Pilot Test of Contingency Management and Brief Motivational Interviewing + Substance Free Activity Session Interventions + Mindfulness-Based Adherence Promotion
Phase: NA
Conditions: Opioid-use Disorder, Opioid Dependence, Treatment Adherence
Sponsor: Karen Derefinko, PhD

 
1 
 
SMART: Project 3, Pilot Trial of 
Interventions  
Manual of Procedures 
 
June 14, 2021

 
2 
Table of Contents 
1. PREFACE 
7 
2. AWARD AND IRB INFORMATION 
7 
2.1. Study Title 
7 
2.2. Award Information 
7 
2.3. IRB 
8 
2.4. Clinical Trials Registration 
8 
3. OVERVIEW 
9 
3.1. Forward 
9 
3.2. Objectives 
9 
3.3. Design and Outcomes 
9 
3.4. Duration 
10 
3.4.1. CM Group Course and Session Duration 
10 
3.4.2. BSM Group Course and Session Duration 
10 
3.4.3. Final Assessment (Participant) 
10 
3.4.4. Final Chart Review 
10 
3.4.1. Figure 1. 
12 
3.5. Sample Size and Population 
12 
3.5.1. Randomization 
12 
3.5.2. Inclusion/Exclusion 
12 
3.6. Cascade of Events 
13 
3.6.1. Baseline Visit 
13 
3.6.2. Sessions1-4: Intervention Treatment 
13 
3.6.3. Visit 4 ONLY: Follow-up Call (Blinded) 
14 
3.6.4. Final Chart Review 
14 
4. INVESTIGATORS AND STAFF 
14 

3 
4.1. Investigators 
14 
4.1.1. Principal Investigator 
14 
4.1.2. Co-Investigators 
14 
4.2. Staff 
15 
4.2.1. Project Management 
15 
4.2.2. Clinical Research Staff 
15 
4.3. Investigator and Staff Responsibilities 
15 
4.3.1. Investigators 
15 
4.3.2. Project Manager 
16 
4.3.3. Study Coordinator 
16 
4.3.4. Interventionists 
17 
4.3.5. Research Assistants 
17 
4.4 Chain of Command 
17 
5. TRAINING PLAN 
17 
5.1. Pre-Initiation Training 
17 
5.2. Ongoing Training 
17 
5.3. Clinical Training 
17 
5.4. Fidelity 
18 
6. RECRUITMENT PLAN 
18 
7. ELIGIBILITY CRITERIA 
18 
8. PROCEDURES 
19 
8.1. Recruitment 
19 
8.2. Enrollment 
19 
8.2.1. Consent 
19 
8.2.2. Baseline Visit 
19 
8.2.3. Randomization 
20 
8.4. Tasks to Complete Prior to the Session 
20 

4 
8.5 Session Windows 
20 
8.6. Intervention Sessions 
20 
8.5.1 CM Intervention Description 
21 
8.5.2. BSM Intervention Description 
22 
8.6. Distressed Participant Procedures 
22 
8.6.1. Warning Signs 
23 
8.6.2. Clinic Distress Procedure 
23 
8.6.3. Telephone/Zoom Distress Procedure 
23 
8.7. Recording 
26 
8.8. Tasks to Complete After the Session 
27 
8.8.1. Data Checking 
27 
8.8.2. Gift Card Distribution 
27 
8.9. Gift cards 
28 
8.9.1 Gift card ordering 
28 
8.9.2. Gift Card Storage 
28 
8.9.3. Gift Card Log Example 
28 
8.9.4. Gift Card Receipt 
28 
8.10. Option for Scheduling 
29 
8.10. Study Contacts 
29 
8.11. Adverse Events 
30 
8.12. Participant Retention for Enrolled Participants 
30 
8.12.1. Standard Interventionist Retention Skills 
31 
8.13. No-Show Protocol 
31 
8.13.1. Rescheduling Protocol 
31 
8.13.2. “Hard to Reach” Participant Retention 
32 
18.13.3. Participant Withdrawal 
33 

5 
18.14. Official Withdrawal Procedures 
35 
9. Data Safety Monitoring Board 
35 
9.1. Members of the DSMB 
35 
9.2 Responsibilities of the DSMB 
36 
10. ALTERNATIVE PROCEDURES: COVID 
36 
11. PROFESSIONALISM IN THE WORKPLACE 
38 
11.1. Professional Attire 
38 
11.2. Professional Behavior 
38 
11.2.1 Respect for Others 
39 
11.2.2 Responsible Use of University Resources 
39 
11.2.3 Standards of Attendance and Timeliness 
39 
12. MEASURES 
40 
12.1. Table 1. List of Measures 
40 
12.2. Measure Items 
41 
11.2.1. Contact Information 
41 
12.2.2. Referral source 
41 
12.2.3. Screening Questionnaire 
41 
12.2.4. Exclusion reason (if applicable) 
42 
12.2.5. Demographics 
42 
12.2.6. Opioid Use Disorder Criteria 
43 
12.2.7. Adherent for first follow up physician visit 
45 
12.2.8. Adherent for second physician visit 
45 
11.2.9. Adherent for third physician visit 
45 
12.2.10. Adherent for fourth physician visit 
46 
12.2.11. Cumulative Adherence 
46 
11.2.12. Urine Toxicology 
46 
12.2.13. Timeline followback 
46 

6 
12.2.14. Delay Discounting 
48 
12.2.15. Opioid Purchase Task 
49 
12.2.16. Engagement in Substance Free Activities 
50 
12.2.17. Time Spent on Activities Worksheet (to be uploaded as picture to database). 
51 
12.2.18. Opioid Cravings Scale 
52 
12.2.19. Buprenorphine-Naloxone dose log 
53 
12.2.20. Dosage of Buprenorphine-Naloxone Prescribed 
53 
12.2.21. Treatment Satisfaction 
53 
12.2.22. Prescription Drug Monitoring data 
54 
12.2.23. PEG for Chronic pain (3 items) 
54 
12.2.24. EQ 5D 5L 
55 
12.2.25. PHQ-2 depression 2 items 
56 
12.2.26. GAD 2 anxiety 2 items only (also a 7 item version) 
56 
12.2.27. Treatment history (times in treatment, medication used) 
56 
12.2.28. Economy Contribution Questions 
57 
12.2.29. For Participants Who Have Stopped Center for Addiction Science Treatment Only 
57 
12.2.30. Adverse Events 
57 
12. CM INTERVENTION SCRIPT 
59 
13. BSM INTERVENTION SCRIPT 
60 
14. VIRTUAL MAILING PROCEDURES 
81 
Appendix A. IRB Approval Letter 
85 
 

 
7 
1. PREFACE 
The purpose of this document is to provide a Manual of Operating Procedures (MOP) for Project 3 of 
SMART (Pilot Test of Contingency Management [CM] and Brief Motivational Interviewing + Substance 
Free Activity Session Interventions + Mindfulness-Based Adherence Promotion [BSM]). The role of the 
MOP is to facilitate consistency in protocol implementation and data collection across participants and 
study staff. Use of the MOP increases the likelihood that the results of the study will be scientifically 
credible and provides reassurance that participant safety and scientific integrity are closely monitored. 
2. AWARD AND IRB INFORMATION 
 
2.1. Study Title 
Full Title: Pilot Test of Contingency Management vs. Brief Motivational Interviewing + 
Substance Free Activity Session + Mindfulness-Based Adherence Promotion 
Working Title: SMART Project 3.  
2.2. Award Information 
 
Funding Agency: National Center for Complementary & Integrative Health (NCCIH)  
Award number: R61AT010604-01 
Grant Title: Testing the Effects of Contingency Management and Behavioral Economics on 
Buprenorphine-Naloxone Treatment Adherence Using a Sequential Multiple Assignment 
Randomized Trial (SMART) Design 
  
Grant Years: 
R61: 2019-2021 
R33: 2021-2024 
  
Grant Amount: $3,358,258 
 
Program Director: Clinical Research – Peter Murray, PhD 
Division of Extramural Research  
National Center for Complementary & Integrative Health (NCCIH)  
6707 Democracy Boulevard, Suite 401 Bethesda, Maryland 20892-5475  
Phone: 301-496-4054  Email: peter.murray@nih.gov 
 

8 
2.3. IRB 
Project number: 20-07418-XP 
The University of Tennessee Health Science Center IRB (FWA00002301) approved this study on 
6/30/20. The IRB Reference number is 20-07418-XP UM. IRB approval is provided in Appendix 
A.   
2.4. Clinical Trials Registration 
This study is now registered with clinicaltrials.gov, registration number, it's NCT04464421.

 
9 
3. OVERVIEW 
3.1. Forward 
The SMART Project 3 manual includes concepts, strategies and materials that have been used in 
previous substance use intervention, abstinence, and medication adherence trials, including the 
interventions that were previously designed by our Co-PI’s and their current and former 
colleagues. Their contribution is acknowledged with thanks to the investigators and staff 
involved.   
It is essential that staff adhere to the Manual of Procedures (MOP) as closely as possible. This 
MOP is the official reference for how the SMART Project 3 study should be conducted.  
Familiarize yourself with these materials. The Principal Investigator, or Project Manager can 
answer questions you have about the study and its implementation.  
It should be noted that Interventionists have some flexibility in implementing the treatment 
protocol to tailor the intervention to participant needs. However, Interventionists should not 
modify the protocol in significant ways and should always notify the Project Manager of protocol 
modifications, deviations, or violations.  
3.2. Objectives 
Our goal with this research is to examine the feasibility, satisfaction rates, and efficacy of two 
interventions, Contingency Management (CM) and Brief Motivational Intervention + Substance 
Free Activities + Mindfulness-Based Adherence Promotion (BSM), to improve buprenorphine-
naloxone adherence during the treatment initiation phase (first 5 physician visits). Once 
feasibility, satisfaction, and efficacy are acquired, Project 4 (the randomized clinical trial 
associated with the R33 award phase) will be conducted. 
Feasibility in this trial is defined as the ability to recruit, treat, and follow up participants within 
the target timeline and costs. Recruitment, intervention, and retention actuals (vs. goals) will be 
evaluated by investigators and the Data Safety Monitoring Board (DSMB) which will be 
convened every 6 months. 
Satisfaction will be measured with a measure developed from previous research. 
Efficacy will be evaluated in terms of participant adherence to buprenorphine-naloxone 
treatment: Showing up to scheduled appointments with their physician at the Center for Addiction 
Science AND the presence of buprenorphine in the participant’s urine screen, conducted as a part 
of buprenorphine treatment.  
3.3. Design and Outcomes 

10 
This project will use a randomized design to compare treatment satisfaction and effectiveness of 
Contingency Management (CM) and Brief Motivational Intervention + Substance Free Activities 
Session + Mindfulness-Based Adherence Promotion (BSM) for medication adherence in patients 
who are initiating buprenorphine-naloxone treatment at our Center for Addiction Science (N=40). 
The interventions will take place across the first 4 physician visits of buprenorphine-naloxone 
treatment, starting after treatment intake.  
Primary outcomes will include feasibility and satisfaction at the fourth weekly intervention visit, 
and an efficacy comparison of intervention group differences in buprenorphine-naloxone 
treatment adherence, defined as (1) attendance at physician visit AND (2) buprenorphine-
naloxone presence in urine toxicology.  
3.4. Duration 
3.4.1. CM Group Course and Session Duration 
Participants assigned to the CM arm will have contact with study staff at their first 
physician visit (intake visit at the Center for Addiction Science) and then at the following 
4 physician visits that are scheduled as a regular buprenorphine-naloxone treatment 
course. These visits are often scheduled at 1 week, 2 weeks, 4 weeks, and 8 weeks 
following intake (see Figure 1). However, this varies with some patients, thus 
participation could potentially last 4 months as a result of them being seen on a monthly 
basis.  Participation at each intervention session is expected to last for 10minutes for the 
assessment and 2 minutes for the intervention (“number wheel” gift card picker).    
3.4.2. BSM Group Course and Session Duration 
Participants assigned to the BSM arm will have contact with study staff at their first 
physician visit (intake at the Center for Addiction Science) and then at the following 4 
physician visits that are scheduled as a regular treatment course. These visits are often 
scheduled at 1 week, 2 weeks, 4 weeks, and 8 weeks following intake (see Figure 1). 
However, this varies with some patients, thus participation could potentially last 4 
months as a result of them being seen on a monthly basis. Participation is expected to last 
10 minutes for the assessment and 30 minutes for the psychosocial intervention.  
3.4.3. Final Assessment (Participant) 
All participants will complete a blinded treatment satisfaction follow-up assessment 
shortly after completing Session 4 Part 1.  Session 4 Part 2 assessment is to be conducted 
by an assessor blind to study conditions. 
3.4.4. Final Chart Review 

11 
To examine treatment efficacy, we will also collect treatment attendance and urine 
toxicology information 30 days after S4 is completed (or the S4 window closes for those 
who do not complete the S4 intervention). 

 
12 
3.4.1. Figure 1.  
 
3.5. Sample Size and Population 
Approximately 40 participants will be recruited from UTHSC’s Center for Addiction Science 
(CAS) for this study. We will randomize 20 participants to the CM group, and 20 participants to 
the BSM group.  
3.5.1. Randomization 
Participants are individually assigned to a study arm by block randomization (1:1 
allocation, block length of 4). 
3.5.2. Inclusion/Exclusion 
Participants must be 18 years of age or older and presenting for buprenorphine-naloxone 
treatment. Patients must be eligible to receive buprenorphine-naloxone medication (e.g., 
Suboxone, Bunavail, Zubsolv) during their visit at CAS. This study is open to all eligible 
participants.  
Notably, due to the nature of medical treatment, approximately 5% of new patients will 
not follow the “regular” intake course of buprenorphine due to previous treatment and/or 
treatment initiation using injectable depot buprenorphine administration (which requires 
fewer physician visits). Because all patients initiating treatment are at risk for drop 
out/low adherence, we wish to enroll these participants if at all possible under the 
stringent timelines for this study. We will therefore enroll unusual buprenorphine-

 
13 
naloxone initiation timelines on a case by case basis, dependent upon the ability to 
complete study procedures within the study timeline.  
3.6. Cascade of Events  
3.6.1. Baseline Visit 
1. Explain study to participants to see if they are interested in participating 
2. Obtain informed consent 
3. Screening for inclusion/exclusion criteria 
4. Complete baseline assessment questionnaires (20 minutes) 
5. Measures of buprenorphine-naloxone dose prescribed at this visit will be 
acquired from the medical record 
6. Randomization 
3.6.2. Sessions1-4: Intervention Treatment 
1) Assessment questionnaires with interventionist 
a) Assessment questionnaires completed (10 minutes) 
2) Engage in either CM (2 minutes) or BSM (30 minutes) 
a) BSM: 
i) All BSM sessions will be audio-recorded in order for the study staff to 
evaluate treatment fidelity. Participants will be informed when the 
recording device is on, and permission to record will be obtained as soon 
as the recording device is started. Participants may refuse to have the 
session recorded and still participate. Audio recordings will be de-
identified and labeled with a Study ID number stored on an encrypted 
computer. 
b) CM: 
i) A number wheel (pickerwheel.com) with varying levels of gift cards 
(ranging from $25 to $100) will be available.  
ii) Urine toxicology will be obtained from the chart to assess presence of 
buprenorphine in urine (criteria for reward).  
iii) Participants will be informed of the buprenorphine toxicology result.  
(1) IMPORTANT: IT IS BUPRENORPHINE IN URINE THAT 
RESULTS IN A GIFT CARD WIN. 
(2) We ARE NOT providing feedback to the participant about the use of 
illicit substance presence in urine as this is not criteria for reward.  
iv) For those who have buprenorphine in urine, they will be allowed to spin 
the wheel in order to determine the amount of gift card earned.   
v) For those who DO NOT have buprenorphine in urine, no wheel spin will 
be done.  
3) Chart Review Following Intervention 

 
14 
a) Information about buprenorphine-naloxone dose, all urine screen results (13 
panel), and other substance use disorder diagnosis will be copied from the 
participant’s medical chart.  
b) Opioid prescriptions will be obtained from prescription drug monitoring 
database.  
3.6.3. Visit 4 ONLY: Follow-up Call (Blinded) 
Assessments and treatment satisfaction questionnaire with Research Assistant blinded to 
treatment condition (25 minutes) 
3.6.4. Final Chart Review 
At 30 days following the last intervention visit, we will conduct a chart review to assess 
outcome data relevant to efficacy (attended medical treatment visit, buprenorphine in 
urine). 
4. INVESTIGATORS AND STAFF 
4.1. Investigators 
4.1.1. Principal Investigator 
Karen Derefinko, PhD 
University of Tennessee Health Science Center 
66 N. Pauline Street, Suite 649 
Memphis, TN 38163 
901-448-2526 
kderefin@uthsc.edu  
4.1.2. Co-Investigators 
  
Karen Johnson, MD, MPH - UTHSC, Study Physician, kjohnson@uthsc.edu 
Fridtjof Thomas, PhD - UTHSC, Statistician, fthomas4@uthsc.edu  
Matt Harris, PhD - UT Knoxville, Economist, mharris@utk.edu 
James Murphy, PhD - University of Memphis, Clinical Psychologist,  
jgmurphy@memphis.edu  
 
 
Ronald L. Cowan, MD, PhD – UTHSC, Clinical Psychiatrist, 
rcowan3@uthsc.edu 
 
Marthinus Zeeman, MD - UTHSC, Interim Clinic Director, 
mzeeman@uthsc.edu   
 

 
15 
Katie Witkiewitz, PhD (Consultant) - University of New Mexico, Clinical 
Psychologist,  
katiew@unm.edu 
 
 
4.2. Staff 
4.2.1. Project Management 
Sarah Hand, MPH 
Research Manager 
shand@uthsc.edu  
 
Vacant 
Research Project Coordinator 
 
4.2.2. Clinical Research Staff 
Lakisa Ards, MPH, CHES 
Research Study Coordinator I 
lards@uthsc.edu  
 
Miesha Sain, BS 
Research Coordinator II 
msain@uthsc.edu  
 
Kristen Barnett, BA 
Research Assistant 
Kbarne42@uthsc.edu 
4.3. Investigator and Staff Responsibilities  
4.3.1. Investigators 
Dr. Karen Derefinko will be responsible for the day-to-day supervision of the project and 
all aspects of the planning, training, recruitment, assessment procedures, and evaluation 
of the interventions in the proposed study. In collaboration with the research team, Dr. 
Derefinko will be responsible for decisions about the development of the study protocol, 
the training needed for the research staff who will be conducting the intervention, and 
interpretation of the data analysis and manuscript and presentation preparation.  
Dr. Zeeman will assist with recruitment from UTHSC Center for Addiction Science and 
provide the medical care associated with the buprenorphine-naloxone medication.  
Dr. Karen Chandler Johnson will serve as the study physician for reporting of Adverse 
Events associated with the intervention, not the buprenorphine-naloxone medication. Dr. 

 
16 
Johnson will assist with decisions about the development of study protocol, interpretation 
of the data, and manuscript preparation. 
Dr. Fridtjof Thomas will oversee data cleaning, including qualitative data, and conduct 
all quantitative analyses. He will assist Dr. Derefinko with the rational assignment of 
participant clauses in qualitative analyses. He will prepare results for publication and 
assist in manuscript development.  
Dr. James Murphy will participate in intervention development and interventionist 
training. He will also conduct treatment fidelity on an ongoing basis. 
Dr. Matt Harris will conduct economic analyses of the intervention costs based upon 
efficacy. 
Dr. Ronald Cowan will assist with the development of recruitment sites and advise on 
study design. 
Dr. Katie Witkiewitz will advise the development of the mindfulness aspect of the 
intervention.  
4.3.2. Project Manager 
The Research Manager (Sarah Hand) will be responsible for general oversight of 
operational activities and supervision of personnel involved in data collection. She will 
be responsible for initial development of the MOP, development and maintenance of the 
database, exporting data and preparing for analysis. Ms. Hand will also prepare monthly 
reports on study progress for the investigative team. 
The Research Project Coordinator will be responsible for direct staff supervision 
(coordinators, interventionists, and research assistants). The Project Coordinator will 
provide feedback on job performance and will conduct evaluations as per the 
requirements of UTHSC. The Project Coordinator will also be responsible for assigning 
additional tasks to staff as necessary to complete study goals. 
4.3.3. Study Coordinator 
The Lead Study Coordinator (Sain) will be responsible for study management tasks, 
including updating the Manual of Procedures, maintaining the regulatory binder 
(electronically), observing and reporting any study procedural issues to the study 
management, monitoring protocol adherence, ensuring data quality, reporting protocol 
deviations, completing IRB submissions/updates, developing consent forms, training 
staff, registering and updating the clinicaltrials.gov record, and relaying specific tasks to 
study staff members.  

 
17 
4.3.4. Interventionists 
The Interventionists (Ards and Sain) will be responsible for participant and clinic 
relations including recruiting, consenting, and assessing participants. Ards and Sain will 
conduct BSM and CM intervention and will receive weekly supervision by Drs. 
Derefinko and Murphy. 
4.3.5. Research Assistants 
The Research Assistant will participate in recruiting, consenting, retention, blinded 
follow up assessments, and data abstraction. 
4.4 Chain of Command 
The Study Coordinator, Interventionists, and Research Assistant will report directly to the Project 
Coordinator regarding job responsibilities and duties. Should there be a conflict in reporting that 
requires the Study Coordinator, Interventionists, and Research Assistant to report to someone 
other than the Project Coordinator, the staff member will report to the Research Manager.  
All Clinical Supervision will be provided by designated Investigators (Derefinko and Murphy). 
5. TRAINING PLAN 
5.1. Pre-Initiation Training 
All Clinical Research Staff will be trained in data collection, data entry, database use, informed 
consent procedures, protection of human subjects, good clinical practice, adverse event reporting, 
and administrative protocols (e.g., randomization, CAS procedures) by the Project Coordinator.  
Interventionists will be trained by Dr. Murphy to deliver the BSM intervention. The Study 
Coordinator will train the Research Assistant in chart review procedures. 
5.2. Ongoing Training 
Data will be monitored throughout the study so that any quality assurance issues can be handled 
in a timely manner. Any issues with data collection, data entry, informed consent, and incentive 
distribution will be monitored by Ms. Hand and the study coordinator and will be addressed at 
biweekly staff meetings. A log of data cleaning completions for staff will also be accessible in the 
study’s OneDrive folder. 
 
5.3. Clinical Training 

 
18 
Clinical supervision for Interventionists will be provided by Drs. Derefinko and Murphy. This 
supervision will cover issues raised by fidelity checks, clinical training maintenance (e.g., 
practice of motivational interviewing techniques), and general evaluation of participants’ 
progress. This is a good time for Interventionists to bring up clinical issues that have happened 
during the week, and for problem-solving how to interact with resistance participants. 
5.4. Fidelity 
All treatment sessions for Project 3 will be audio recorded. Fidelity for content will be conducted 
on 50% of all sessions (40 of a total 80 intervention sessions recorded) by Dr. Derefinko. 
Feedback regarding Interventionist performance will be provided by Dr. Derefinko and will be 
addressed in supervision.   
6. RECRUITMENT PLAN 
Recruitment will occur through the CAS clinic and the American Recovery Clinic (ARC). Dr. Zeeman 
and the other physicians at the clinic will be informed of the eligibility criteria so they can note potential 
participants. At each patient’s visit, the physician will tell the new patient they may be eligible to 
participate in research that will assist them in adhering to buprenorphine treatment. The physician will 
make sure to explain that this is not required and is different from what they are receiving as standard 
treatment. If the patient expresses interest, the doctor will bring the patient to a research room where a 
research staff member will explain the study. The staff member will check for eligibility, and if eligible, 
consent the participant. Additionally, staff members may approach the physician or clinic staff in regard 
to determining some eligibilty criteria for the patients after reviewing the clinic’s schedule of 
appointments.   
Please see the “Alternative Procedures: COVID” section if in-person recruitment is not possible.  
7. ELIGIBILITY CRITERIA 
Participants must meet the following eligibility criteria to participate in this study:  
● Present for an appointment at CAS or ARC for buprenorphine-naloxone treatment of OUD 
● Be eligible for buprenorphine-naloxone treatment (e.g., Suboxone, Bunavail, Zubsolv) as 
determined by Dr. Zeeman 
● At least 18 years of age or older 
● Access to a telephone 
● Ability to understand consent procedures 
● Physician confirmation of a “regular” initiation visit schedule (to ensure completion within pilot 
study window) 

 
19 
8. PROCEDURES 
 
8.1. Recruitment 
Recruitment will occur through the CAS and ARC clinics. Potential participants will be identified 
from the appointment schedule at the beginning of each day by Dr. Zeeman or the attending 
physician. At each patient’s visit, the physician will tell the patient they may be eligible to 
participate in research. The physician will make sure to explain that this is not required and is 
different from what they are receiving as standard treatment. If the patient expresses interest, the 
doctor will bring the patient to a research room where a research staff member will meet with the 
participant. The study will be explained to the participant using the consent statement. 
Additionally, staff members may approach the physician or clinic staff in regard to determining 
some eligibilty criteria for the patients after reviewing the clinic’s schedule of appointments.   
8.2. Enrollment 
8.2.1. Consent 
Project staff will answer any questions about the entire process and an informed consent 
will be obtained. No study assessment will take place prior to obtaining consent from 
each subject. Standard language in our consent form assures the participants of the 
confidential nature of the study and the ability to withdraw from the study at any time. 
The consent forms will contain HIPAA language. This study will be approved by the 
UTHSC IRB.  
Participants will be given a copy of the consent statement for their records. The consent 
discussion will be documented on the eligibility page of the FileMaker Database. 
Participants will be informed that regardless of their adherence to clinic visits or use of 
buprenorphine-naloxone (the primary study outcome), they will be eligible to complete 
assessments at scheduled intervals and will be compensated for these assessments. This 
will enable the study team to discover whether drop out of treatment leads to relapse to 
opioids and if treatment is sought elsewhere. 
8.2.2. Baseline Visit 
After consent, the participant will complete the baseline assessments with the study team 
member. Dependent upon COVID-19 County and UTHSC requirements for in-person 
assessments, participants will either fill out paper forms on their own or be interviewed 
by the staff member. Responses will be recorded in the FileMaker database. 
If a participant is unable to complete their baseline assessment on the day of enrollment, 
that is ok. Assessments may also be completed over the phone. Assessments however, 
must be finished before Visit 1. 

 
20 
 
8.2.3. Randomization 
Once consent has been signed by the participant and study staff and the baseline 
assessment is complete, the staff member will randomize the participant. The 
randomization scheme is posted on the “SMART: Project 3 Regulatory” OneDrive file. 
Only appropriate staff have editing privileges for this document to avoid tampering. 
Participants will be immediately informed regarding the treatment arm they have been 
assigned to.  
Participants will also be randomized to a counselor who will work with them throughout 
their participation in the study. 
8.4. Tasks to Complete Prior to the Session 
Please remember: Both CM and BSM conditions need to be recorded. 
8.5 Session Windows  
Following the Baseline Visit, participants will complete 4 sessions  in no greater than 30-day 
increments. These visits will be referred to as Session 1 (S1), Session 2 (S2), Session 3 (S3), 
Session 4 (S4). The window scheduling guidelines for sessions are as follow:  
§ 
S1 opens when their 1st physician return visit is scheduled. 
§ 
S1 closes the day before their S2 is scheduled OR at 30 days from S1 window open. 
§ 
S2 opens when their 2nd physician return visit is scheduled or the day after S1 window 
closes (e.g. if S1 is not completed in order to keep under the 30 day maximum). 
§ 
S2 closes the day before their S3 is scheduled OR at 30 days from S2 window open. 
§ 
S3 opens when their 3rd physician return visit is scheduled or the day after S2 window 
closes. 
§ 
S3 closes the day before their S4 is scheduled OR at 30 days from S3 window open. 
§ 
S4 opens when their 4th physician return visit is scheduled or the day after S3 window 
closes. 
§ 
S4 closes 4 weeks from S4 window open (but continue to try to assess). 
 
8.6. Intervention Sessions 
Prior to the session, Interventionists will prepare for the brief assessment conducted during each 
treatment session by finding the participant in the Filemaker database, or if offline, entering the 
participant information on the top of the assessment materials.  

 
21 
Interventionists will also prepare to administer the appropriate session (1, 2, 3, or 4) (within the 
appropriate condition).  
In addition, Interventionists will prepare the recording device to ensure that the session is 
recorded. If remote, the interventionist will text or email the participant a Zoom telephone 
number with a meeting ID for them to call and be placed in a meeting. The interventionist will 
ensure that Zoom is recording once permission is granted from participant. All sessions will be 
recorded and uploaded to OneDrive folder (SMART Project 3/Recordings) and labeled with the 
participant’s study ID, session number (1, 2, 3, 4), condition (CM vs. BSM), and staff initials. 
(e.g. 301 S2 BSM AB) 
At each session , the Interventionist will meet with the participant to complete the assessment 
questionnaires and complete the intervention – either a BSM session or a wheel spin for 
additional gift cards for CM (if requirements are met). 
If the participant drops out of treatment at the Center for Addiction Science, they will no longer 
receive the CM or BSM. However, all assessments will be conducted regardless of the 
participant’s adherence to medical treatment at the CAS. Upon completion of the assessment, 
participants will still earn the $50 gift card. This will allow us to understand the reason for the 
participant’s non-adherence to treatment, and to evaluate whether these individuals pursue 
treatment elsewhere. 
The intervention scripts are available in section 13 of the manual of procedures.  
8.5.1 CM Intervention Description 
Record all interactions with CM participants.  
Participants who are assigned to CM will complete their assessments with the 
Interventionist. After the assessments are complete, the study staff will check the results 
of the urine screen. In the event that a participant misses their clinic visit, assessments 
may still be completed at any time during the window. If the participant completes their 
clinic visit before the session window closes they may be contacted to complete a wheel 
spin, if eligible.  
Adherent (buprenorphine present in urine) 
If the participant is determined as adherent (i.e., buprenorphine present in urine), they 
willspin a computer number wheel with varying value gift card amounts ($25-$100) 
with a bonus $100 gift card given for consecutive adherence (attendance at the clinic 
and buprenorphine present in urine) across all 4 sessions . The number wheel will 
consist of 4 $25 gift cards, 3 $50 gift cards, and 3 $100 gift cards.  
Non-Adherent (buprenorphine not present in urine) 

 
22 
If the participant is determined as non-adherent (i.e., buprenorphine not present in 
urine), they will NOT spin the number wheel. 
 
8.5.2. BSM Intervention Description 
Record all interactions with BSM participants.  
Participants who are assigned to BSM will complete their assessments with the 
interventionist. After the assessments are complete, the interventionist will engage the 
participant in the BSM intervention. A SOBER handout will be given to the participant at 
their baseline visit (See section 13). Participants will also receive a Tips for Improving 
Self-Control handout at session 4.  
If a participant misses a session, the interventionist will continue with the next session in 
numerical order. So, if a participant is on S2 and missed S1, the interventionist will 
deliver S1 content during session 2. 
This intervention consists of 4 sessions: 
Session 1 
This session will cover reasons for attending treatment, goals, time spent on valued 
activities, future events, and mindfulness-based coping (SOBER). 
Session 2 
This session will substance goals check in, substance free activities, and mindfulness-
based coping (SOBER). 
Session 3 
This session will cover goals check in, substance free activities check in, and 
mindfulness-based coping (SOBER). 
Session 4 
This session will cover self-control improvement, and review goals, substance free 
activities, and mindfulness-based coping (SOBER). 
In the event that a participant misses their clinic visit, assessments may still be completed 
at any time during the window. If the participant completes their clinic visit before the 
session window closes they may be contacted to complete a counseling session.  
 
8.6. Distressed Participant Procedures  

 
23 
Detecting severe emotional distress is the responsibility of all SMART staff who interact 
with participants.  
8.6.1. Warning Signs 
Warning signs include:  
● Talking about/making plans for suicide (“I’m going to end it..”)  
● Expressing hopelessness about the future (e.g., Things will never get better for 
me...”)  
● Displaying severe/overwhelming emotional pain or distress (“I can’t take this 
anymore, I’m at a breaking point!”)  
● Showing worrisome behavioral cues or marked changes in behavior, particularly 
in the presence of the warning signs above. Specifically, this includes significant 
withdrawal from social connections/situations, changes in sleep (increased or 
decreased), anger or hostility that seems out of character or out of context, recent 
increased agitation or irritability  
People may give direct as well as indirect verbal cues about suicidal thoughts. These 
typically communicate feelings of being trapped, helpless, and hopeless  
SMART staff should use clinical judgment to further assess whether distress indicates 
lasting and unchanging conditions:  
Example of limited distress (time-limited/likely to change):   
● Participant: “My husband is driving me crazy! I can’t take this 
anymore!”   
● Interventionist: “Sounds like you’re experiencing some stress right now.”  
● Participant: “Yeah, but he’s only doing overtime this week. Next week 
we’re back to normal.”  
● Example of lasting/unchanging distress:   
● Participant: “I lost another job, the third one in a row. It never gets 
better.”   
● Interventionist: “Sounds like you’re experiencing some stress right now.”  
● Participant: “Yeah, I’m useless, always have been. I’m a burden to my 
family. At least if I died they could get the insurance money.”  
8.6.2. Clinic Distress Procedure 
If the participant is seen in the clinic, the interventionist will follow UCH’s Behavioral 
Health Emergency-Suicidal Ideation procedure (policy number: BH.001), which requires 
that the study staff inform the behavioral specialist on staff or clinic doctor (Dr. Zeeman).  
8.6.3. Telephone/Zoom Distress Procedure 

 
24 
During phone assessments and psychosocial intervention sessions, the interventionist will 
follow the procedures below. If the participant is not at the clinic, the following rules will 
be enacted: 
1. Initiate Discussion: 
a. “I am concerned about you. It sounds like you are experiencing very 
serious emotional distress right now. Before we continue with the 
session, I am going to need to ask you some questions to ensure you are 
doing ok.” 
2. Get physical location 
a. “Just in case we get disconnected, I am going to need you to tell me 
where you are. Sometimes, when people feel this upset, they need 
immediate help, and I want to make sure I can provide that for you.” 
3. Assess for suicidal ideation/intent/plan: 
“Let me ask you some questions about how severe your distress is.” 
Suicide Behaviors Questionnaire-Revised (fillable for printout) 
Osman eta/ (1999) Revised. Permission for use granted by A. Osman, MD 
Question 
Possible answers 
Points  
Subtotal 
1. Have you ever thought about 
or attempted to kill yourself? 
Never 
1 
______ 
It was just a brief passing thought 
2 
I have had a plan at least once to kill 
myself but did not try to do it 
3 
I have had a plan at least once to kill 
myself and really wanted to die 
3 
I have attempted to kill myself, but did 
not want to die 
4 
I have attempted to kill myself, and 
really hoped to die 
4 
 
 
 
 
2. How often have you thought 
about killing yourself in the past 
year? 
Never 
1 
______ 
Rarely (1 time) 
2 
Sometimes (2 times) 
3 
Often (3-4 times) 
4 
Very Often (5 or more times) 
5 
 
 
 
 
3. Have you ever told someone 
that you were going to commit 
suicide, or that you might do it? 
No 
1 
______ 
Yes, at one time, but did not really want 
to die 
2 
Yes, at one time, and really wanted to 
die 
2 
Yes, more than once, but did not want to 
do it 
3 
Yes, more than once, and really wanted 
to do it 
3 
 
 
 
 
4. How likely is it that you will 
attempt suicide someday? 
Never 
0 
______ 
No chance at all 
1 
Rather unlikely 
2 

 
25 
Unlikely 
3 
Likely 
4 
Rather likely 
5 
Very likely 
6 
 
 
 
 
TOTAL FOR ALL ITEMS:  
 
Scoring: 
< 4 = Not reportable 
Assessment will be documented. 
 
“It sounds like you are definitely experiencing some distress, but you 
have a handle on it at the moment.” 
 
Provide list of resources. 
 
Document events in file. 
 
 
4-6 = Mild to 
Moderate Distress 
Assessment will be documented. 
 
Participant will be provided a listing of community resources and 
encouraged to seek help. 
 
“It sounds like you are definitely experiencing some distress. I 
encourage you to consider reaching out to one of these organizations 
for help or support.” 
 
Provide list of resources. 
 
Document events in file. 
 
 
7 or more points but 
no immediate plan = 
Severe Distress and 
Suicidal Ideations, 
With No Intent or 
Plan 
Develop an action plan to get help from a mental health professional.  
The action plan will be documented. 
 
“You are definitely experiencing distress but it sounds like you are 
not in immediate danger of self-harm. Is this correct?” 
 
“I would like to come up with a plan to help you get some support. Is 
there someone you can talk to about your distress?” 
 
Provide list of resources. 
 
Document events in file. 
 
Follow up with participant in two days to ensure help seeking is 
occurring. 
 
Document follow up in file. 
 
Severe distress incidents will be reported to an on-site Clinical 
Supervisor (Dr. Marthinus Zeeman). 
 
 
7 or more points and 
immediate plan = 
Severe Distress and 
Suicidal Ideations 
With Intent or Plan 
Maintain contact with the participant and put the patient in touch 
directly with emergency services (either by phone if in person or by 
calling 911, if on telephone). Maintain contact until responsibility is 
transferred. 

 
26 
 
“Because you indicated to me that you intend to harm yourself and 
that this is likely, I am going to remain with you (on the phone) until 
help arrives. I am going to call emergency services to come speak 
with you at the address you provided me at the start of these 
questions. While I arrange this, I want to keep speaking with you 
about how you are feeling and what you need to do to feel better.” 
 
If crisis situation (i.e., person is very agitated), may need to text 
another staff member to call local 911 and provide address  
This works even if the person is not in Memphis – the police will 
transfer the information to the local precinct. 
 
§ 
National Suicide Prevention Lifeline: 1 (800) 273-8255 
o Hours: 24 hours, 7 days a week 
o Languages: English, Spanish 
o Website: www.suicidepreventionlifeline.org)    
 
Contact Dr. Karen Derefinko to alert her to the situation, during or 
immediately after. 
 
All actions should be documented in file. 
 
Severe distress incidents will be reported to an on-site Clinical 
Supervisor (Dr. Marthinus Zeeman). 
 
Adult crisis resources in Shelby County: 
§ National Suicide Prevention Lifeline – 1-800-273-TALK (8255) 
§ Memphis Police – (901) 545-2677 OR 911 
§ Mobile Crisis – Adult: (901) 577-9400 
§ Mobile Crisis – Children and Youth: 1-(866) 791-9226, (901) 252-7734 
§ Memphis Crisis Center – (901) 274-7477 
§ Community Behavioral Health – (901) 577-1004, 1-800-538-7540 
§ Lakeside Hospital – (901) 377-4733, 1-800-323-5253 
§ MSARC (Memphis Sexual Assault Resource Center) – (901) 272-2020 
§ St. Francis Hospital Clinical Assessment – (901) 765-1400 
§ YWCA Abused Women’s Services – (901) 725-4277 
§ Community Mental Health Centers 
o Case Management, Inc. (formerly Southwest Mental Health 
Center) 
14 North Bellevue Boulevard, Memphis, TN 38104 
4041 Knight Arnold Road, Memphis, TN 38118 
(901) 821-5600 
o Alliance Healthcare Services Memphis locations: 
§ 3810 Winchester Road or 3628 Summer Avenue: (901) 
369-1400 
§ 2579 Douglas Avenue: (901) 369-1400 
§ 2100 or 2150 Whitney Avenue: (901) 353-5440 
§ 951 Court Avenue: (901) 259-8900 
 
8.7. Recording 

 
27 
All sessions (CM and BSM) will be recorded. The staff member will turn on the recording device, 
then while recording, will inform the participant that the device has started recording and ask 
permission to continue. At the end of the session, the staff member will inform the participant that 
the device is being turned off. 
Once the participant has left, the recording will be uploaded to a study computer, then uploaded 
to OneDrive and labeled with the Study ID, session number, group, and the staff member initials. 
Once the recording is uploaded, it should be deleted from the recording device and the computer 
(if applicable). 
8.8. Tasks to Complete After the Session 
8.8.1. Data Checking  
Interventionists and the Research Assistant will conduct routine checks of paper forms 
and the questionnaires in the database following session completion. Checks regarding 
data fidelity (e.g., values appropriate to the field, such as age = 99) and data completeness 
(was a question or measure missed) will be completed. If the correct value is unknown by 
the Interventionist, the participant will be re-contacted to request the correct data value. 
The Research Manager will be in charge of data cleaning. All data will be exported every 
3 months for review and cleaning. 
A data cleaning log for each session is located on OneDrive for staff to log completed 
data checks.  
8.8.2. Gift Card Distribution 
All gift cards will be pre-purchased, hard copy gift cards.  
Baseline Assessment Incentive: All participants will receive a $50 gift card for enrolling 
and completing a baseline visit.  
Assessment Completion Incentive: After each assessment, participants will receive a 
$50 gift card to their choice of store (Kroger or Walmart). Research staff will log out the 
gift card(s), make a photocopy of the gift card(s), and have the participant sign the 
photocopy to document distribution. Research staff will date the photocopy and file 
appropriately.   
CM Group Rewards: Patients in the CM arm will have the opportunity to spin a 
computer number wheel if it is determined that buprenorphine is in their urine at the 
physician visit. If all 4 urine screens across the study duration show buprenorphine in 
urine, the participant will receive a $100 bonus gift card.  
This is allowed by UT policy FI0313. 

 
28 
8.9. Gift cards 
8.9.1 Gift card ordering 
The Study Coordinator will be responsible for ordering gift cards and maintaining 
inventory. Gift card orders should be sent to Andrea Briggs via email. Orders typically 
take 3-6 weeks to receive. 
8.9.2. Gift Card Storage 
When a gift card order is received, the gift cards are stored in the Pauline 6th floor safe 
until they can be transported to CAS. The safe at CAS can have a maximum of $3,000 in 
gift card value at any time. Gift cards and gift card log will be kept in a locked safe in a 
storage closet  in the clinic. The safe should only be opened when a gift card is needed 
and only 3 staff members are allowed to have the access code to the safe per UT Fiscal 
Policy. 
Gift cards are to be kept in the locked study safe at all times. Gift cards should only be 
checked out of the safe when they are ready to be disbursed to a participant. The gift card 
log will be kept in the safe and filled out each time a gift card is moved in or out of the 
safe. We will also keep a google sheet logging the incentives.  
 
8.9.3. Gift Card Log Example 
 
 
Card Number  
Pin 
Amount 
LOG IN 
Initials 
LOG IN 
Date 
DISPENSE 
Date 
LOG 
OUT 
Initials 
 
 
 
  
  
  
  
 
 
 
  
  
  
  
 
 
 
  
  
  
  
 
 
 
  
  
  
  
 
 
 
  
  
  
  
8.9.4. Gift Card Receipt 

 
29 
Study ID 
 
 
 
Date: 
 
 
 
The participant and I, the research staff member, checked the balance of the gift card before 
distribution. We discussed that the SMART Research Study is not responsible for and will not replace 
lost or stolen gift cards once the gift card has been disbursed. 
Staff Initials: 
 
Gift Card Amount: 
 
Participant Initials: 
 
Quantity: 
 
 
8.10. Option for Scheduling 
Since the patient will have scheduled their next physician appointment, we will not schedule their 
next research appointment (unless we are remote, in which case the session will be yoked to their 
CAS appointment, to be scheduled immediately following their appointment at the CAS). We 
will use the medical charts to block off time for the participant’s S1 (ex: the participant schedules 
a 2:00 pm doctor’s appointment, their research appointment will be at 2:45 pm). Appointment 
times are not stringent, so if a participant gets done with their physician visit early and their 
assigned counselor is free, they can complete their session  early. 
Note on Assessment for participants who fail to attend treatment: 
The study staff will continue to contact the participant to complete their assessments if a 
participant stops attending CAS. Study staff will inform the participant that they will not be 
receiving treatment (i.e., CM of BSM intervention). However, they can continue to earn gift cards 
for completing assessments. Assessments and intervention may occur in two visits if a participant 
missed their clinic visit, but later rescheduled and completed their clinic visit before the closing 
of the session window. Study staff will also inform the participant that information shared will 
not be disclosed to clinic staff or doctors. 
8.10. Study Contacts 
Study Phone: 901-448-3099 
Email: smartresearch@uthsc.edu 
Website: https://www.getsolidinitiative.org/smart 
Facebook: https://www.facebook.com/GetSolidInitiative  

 
30 
8.11. Adverse Events 
If patients experience an adverse event during the course of the study, we will conduct an 
assessment, complete an Adverse Event form, and follow the adverse event reporting system as 
required by our IRB and NIH regulations. We will assess Adverse Events at each intervention 
session.  
Adverse events are defined as any untoward or unfavorable medical occurrence in a human 
subject, including any abnormal sign (for example, abnormal physical exam or laboratory 
finding), symptom, or disease, temporally associated with the subject’s participation in the 
research, whether or not considered related to the subject’s participation in the research. 
Serious adverse events are any adverse event temporally associated with the subject’s 
participation in research that meets any of the following criteria: 
(1) results in death; 
(2) is life-threatening (places the subject at immediate risk of death from the event as it 
occurred); 
(3) requires inpatient hospitalization or prolongation of existing hospitalization; 
(4) results in a persistent or significant disability/incapacity; 
(5) results in a congenital anomaly/birth defect; or 
(6) any other adverse event that, based upon appropriate medical judgment, may 
jeopardize the subject’s health and may require medical or surgical intervention to 
prevent one of the other outcomes listed in this definition 
At every session, we will assess both Adverse Events and Serious Adverse Events (AEs and 
SAEs).  
All SAEs related to study participation are to be reported to the Project Manager who will report 
to the Study Physician (e.g., Dr. Karen Chandler Johnson) within 24 hours of occurrence, and are 
to be reported to the UTHSC IRB immediately. 
UTHSC’s IRB operating procedures regarding AE’s can be found here: 
https://www.uthsc.edu/research/compliance/irb/researchers/documents/adverse-event-
reporting.pdf  
We do not anticipate any study related SAEs (we haven’t observed treatment related SAEs in any 
of our studies) as our study involves an over-the-counter medication and psychosocial 
intervention.  
A copy of the Adverse Events reporting tool is located in the Measures section. 
8.12. Participant Retention for Enrolled Participants 
If a participant is having difficulty participating in sessions regularly, it is the job of the 
Interventionist to find out obstacles to treatment and work with the participant to overcome these 
obstacles.  
Once a participant is enrolled, it is the Interventionist’s goal is to retain them in the study.  

 
31 
In addition to FileMaker, Interventionists should regularly update the Retention Log in OneDrive 
with their active participants. Interventionists have the flexibility to provide participants whatever 
form of treatment is needed to retain them in the study. Before offering participants special 
arrangements, Interventionists will review these cases with the Study Team.  
Procedures are in place to assist you in retaining participants. These include incentives for 
assessments ($50 gift cards), as well a t-shirt and welcome bag (snacks and cloth face mask) that 
will be provided at enrollment.  
8.12.1. Standard Interventionist Retention Skills 
Always take a positive approach with the patient.  Always be understanding of their 
situation. 
Acknowledge situation when appropriate, (e.g., condolences for a recent family death; 
inquiring how they are doing when ill or hospitalized.) 
Always document the reason a participant did not participate and any suggested approach 
for handling the missed session. Also document on the Process Note any participant 
circumstances that we may want to stay aware of (e.g., death in family, illness).  
Standard retention practices include: 
• 
Birthday cards 
• 
Holiday cards 
• 
Reminders pre-session (day before) 
8.13. No-Show Protocol 
If enrolled participants are not available for a session (despite attending the medical visit), we will 
attempt to contact non-enrolled participants in a number of ways.  
Participants who “no show” for a scheduled session will first be called or texted at 15 minutes 
past the appointment time. The staff member should contact the participant to check on him/her 
and attempt to reschedule the appointment (i.e., leaving a message to this effect if the participant 
does not answer the phone). If the participant is not contacted the day of the appointment, the 
interventionist should also follow-up with the participant the next day in an attempt to reschedule. 
Alternate contact info may also be utilized in efforts to reach the participant.  
8.13.1. Rescheduling Protocol  
Participants will be allowed unlimited occasions of rescheduling a session , as we want to 
retain all enrolled participants in the study. However, staff (together with the Project 
Coordinator) should use their judgment about this rule on a case-by-case basis and 

 
32 
always prioritize completing assessments if the participant cannot complete intervention 
sessions.  
8.13.2. “Hard to Reach” Participant Retention 
Participants who miss sessions and remain in session window should be subject to 
intensive retention efforts by Interventionists.  
Main strategy: Starting with preferred modality, cycle through different modalities, days 
of the week, times of day, and different strategies to reach participant. 
Modalities: phone, text, email, mail, alternate contact 
Phone call strategies: 
Call and leave a voicemail 
Call once then follow up with text (ex: Hi _____, I just left you a message trying 
to reschedule, if you can call me back when you get a chance that would be 
great!) 
Call once, then call again 10-15 minutes later (try leaving a VM the first time, 
but if they don’t answer the second time don’t leave another message) 
Call with google voice number or clinic telephone to catch participant off-guard 
Call alternate, ask if they know a good time to call participant or if you can leave 
a message with them (do not disclose the purpose of the study to alternate) 
Alternating times of day within a week 
For those who are early or middle of their window, try one morning call, one 
afternoon call, and one evening call within the span of a week 
Ex: Monday afternoon, Tuesday morning, Thursday evening 
Can also send texts or other modalities during this time 
E-mail and Mailing strategies: 
For participant who you’ve had a hard time reaching via quicker methods 
Examples: 
Hope you’re doing well! We’ve had a hard time getting a hold of you by phone 
so I just wanted to check in. If you could give me a call at 901-448-3099, we’d 
love to get you scheduled for you next session! 

 
33 
Just wanted to check in on you because I’ve had a hard time getting a hold of 
you. The last day for you to do this session is _______. If you can give me a call 
at 901-448-3099, we can figure out a time that works for us to get this session in! 
Facebook Message Strategies: 
We will have links stored for participants who message us on Facebook. This 
will allow us to send a message to those participants from the SMART page. 
Use the same type of language used in mailings and/or text messages 
Example 
Hope you’re doing well! We’ve had a hard time getting a hold of you by phone 
so I just wanted to check in. You can either message me back on here or give me 
a call at 901-448-3099. 
Just wanted to check in on you because I’ve had a hard time getting a hold of 
you. The last day for you to do this session is _______. Would you have some 
time Tuesday at 9 to do your session? 
Also a great tool to get updated contact information if needed 
Contact attempts per stage in window: 
Early to mid window: contact at least 3 times a week using at least 2 different 
modalities 
Late window (last week): contact daily at different times of the day, leave 
message with last day to do session so the participant has a deadline. 
As a last chance effort the day before a window closes, you could text the 
participant and offer them a slot the next day. You can tentatively book them on 
the calendar and even if they don’t respond, go ahead and try to call at the 
suggested time. 
Ex: Hi _______, tomorrow’s our last day for us to get this session in. Could I call 
you at 10:00 tomorrow to do that? 
Should the window for a session close, retention efforts should be stopped, but 
resumed just prior to the opening of a new window. 
18.13.3. Participant Withdrawal 
Some participants may passively drop out of treatment, whether because of scheduling 
conflicts, life stressors, disappointment with their outcome, or not liking the phone 
sessions. Some participants will develop conflicts or barriers that keep them from 

 
34 
attending phone sessions on a regular basis and may wish to actively withdraw from the 
study.  
These participants may or may not be aware that there are options to help them stay 
involved. 
For participants who decline all offers of intervention, be sure to leave the door wide 
open.  
If the participant is reached, the Interventionist will attempt to re-engage the participant 
with any of the following techniques: 
Maybe we can change something? 
Discuss the barriers with the participant. Help the participant brainstorm solutions to the 
barriers or any alternative options that will help the participant stay involved.  
Offer flexible schedules for participating in phone sessions. Can they participate in just 
two meetings a month? One meeting a month? Can they take a break for a month or two 
and then see if they can resume phone sessions?  Stick to just email communication for a 
period of time? 
The Project Coordinator may also contact the participant to see if switching counselors 
would help the participant re-engage. 
Document all efforts to keep the participant enrolled in the study on the Contact Notes. 
Maybe you will want to start again at the next session ? 
Maybe the participant could take a break from the study (become inactive), and possibly 
resume later if there are later visits that could be completed (ex: a participant cannot 
complete S1 but they might want to be contacted at  S2).  Make sure they are aware that 
you are available to help them with questions or concerns at any time and that we may 
periodically contact them throughout the remainder of the study. Interventionists should 
indicate that they would be happy to work with a participant anytime they are ready to 
focus again on smoking cessation.  
Can you still participate in the last follow up? 
If the participant does not want to continue participating in phone sessions, emphasize to 
them the importance of completing the  assessments. Ask the participant if he/she is 
willing to complete these measures. The participant would be considered inactive and 
would still receive the $50 gift card if the session  is completed (S1, S2, S3, or S4). 
Emphasize that their data is needed for the success of the research, whether or not they 
have been actively participating or not and whether or not they’ve quit. In order to answer 
the research questions, we need to know what worked and what DID NOT work for 

 
35 
participants so we can help others better in the future. Explain that without their data, we 
will be missing some of the most crucial information we need to collect.  
Participants who do not complete the Baseline assessment within the designated window 
will be administratively withdrawn from the study since they did not complete any 
treatment. 
18.14. Official Withdrawal Procedures   
Document all efforts to keep the participant enrolled in the study on the Contact Notes. 
If, after all alternative options are explored and exhausted, the participant still chooses to 
withdraw from the study, document the date of the discussion. 
The Study Coordinator will put notification of intent to withdraw in writing in a letter to 
the participant. 
A copy of an official withdrawal letter is provided in Appendix B.  
Study Coordinator will then: 
Mark as withdrawn on the Regulatory Form. 
Report to IRB on annual progress report. 
Notify PI by email if there are abnormal circumstances surrounding the withdrawal. 
9. Data Safety Monitoring Board 
9.1. Members of the DSMB 
Chair: Christopher Barrick, PhD, Department of Family Medicine, Jacobs School of Medicine 
and Biomedical Sciences, State University of New York at Buffalo, Phone: (716) 887-2538, 
Email: barrick@ria.buffalo.edu 
Member: Margaret DeBon, PhD, Executive Director, Baptist Clinical Research Institute, 
BMHCC Corporate Office, Phone: (901) 226-1673, Email: Margaret.DeBon@BMHCC.org 
Member: Todd A DeWees, PhD, Senior Associate Consultant I, Mayo Clinic, Phone: 480-301-
9458, E-mail: DeWees.Todd@mayo.edu 
Member: Iliyan Ivanov, MD, Associate Professor in Child and Adolescent Psychiatry, Icahn 
School of Medicine at Mount Sinai, New York, NY, Email: iliyan.ivanov@mssm.edu 

 
36 
Member: R. Kathryn McHugh, PhD, Assistant Professor of Psychology, Department of 
Psychiatry, Harvard Medical School, Phone: 617.855.3169, Email: 
kmchugh@mclean.harvard.edu  
9.2 Responsibilities of the DSMB 
The roster of proposed DSMB members will be submitted to NCCIH prior to initiating 
recruitment (see DSMB Charter, separate document due to length). Types of credentials that our 
intended DSMB members will possess are: 1) experience conducting behavioral intervention 
studies; 2) experience with treating opioid use disorder; and/or 3) biostatistical expertise in 
intervention studies. As DSMB members, they will review the reports sent by the study 
statistician (at the frequency outlined above) and will use the checklist attached to this document 
(Appendix C) to determine whether there is any corrective action, trigger of an ad hoc review, or 
stopping rule violation that should be communicated to the study investigator, the University of 
Tennessee Health Science Center IRB and the NCCIH.   
10. ALTERNATIVE PROCEDURES: COVID 
In the case that study staff are unable to recruit and provide the intervention in-person, the 
following alternative procedures will take place.  
 
All individuals entering the CAS must abide by the rule of wearing a face mask at all times.  
. 
 
Procedures 
Recruitment  
Study staff will review the clinic schedule the day before and the day of to  determine 
which patients are eligible. Study staff will come into the clinic to discuss the study and 
recruit eligible patients. 
Enrollment 
Consent  
If the patient agrees to participate, the study staff will consent in person. The 
study team will take all precautions to protect themselves and the patient (e.g., 
PPE and practice social distancing).  
For participants unable to complete consent in person and who have access to a 
computer, a DocuSign link will be sent immediately to conduct consent during 
the call. A blank copy of the consent form will be mailed to the participant  

 
37 
All other consent procedures will be the same as written above. 
         
 
Randomization 
Once the patient consents and completes baseline assessments, randomization 
procedures will stay the same as written above. 
Baseline Assessment 
Baseline assessment will take place in-person or over the telephone. Assessment must be 
completed prior to the participant’s first physician return visit. Procedure will stay the 
same as written above. 
Sessions 1-4 
Following the Baseline Visit (BV), participants will complete sessions on the same 
schedule as their appointments at CAS, but windows will not exceed 30-day increments. 
Sessions and follow-up procedures will stay the same as written above with a few 
modifications (see below).  
  
 
CM Session 
Study staff will contact participants by phone or text to schedule a time to 
complete their assessment and CM intervention via Zoom call on the day of the 
participants' scheduled appointment. The participant will be given a 30-day 
window (starting with the day of their office visit) to complete the assessment or 
it must be completed prior to the next scheduled clinic visit for the patient. 
If participant attends the physician appointment and has buprenorphine in urine: 
Once the assessment is complete, the study staff will spin the number wheel 
while the participant is on the phone (“virtual wheel”). The study staff will 
inform the participant of the gift card amount earned and will immediately mail 
the gift card. 
Study staff will also take a screenshot of the number wheel results, and text or 
email the participant the photo. The study staff will upload the photo to 
FileMaker for future records.  
For those who DO NOT have buprenorphine in urine:  
Once the assessment is complete, the study staff will inform the participant that 
they did not have buprenorphine in their urine and are not eligible for the virtual 
spin.  

 
38 
BSM Session 
Study staff will contact participants by phone or text to schedule a time to 
complete their assessment and intervention via Zoom call. The call will be 
scheduled and completed within 30-days or the day before their next scheduled 
office visit. The intervention portion will be audio recorded.  
         
 
Recording procedures will be the same as written above. 
Incentives 
 
 
Gift Card Distribution Procedures 
Procedures will stay the same as written above with slight modifications. Gift cards will 
be mailed. A google sheet will be used to track the gift cards distributed.  
Virtual mailing procedures in section 14.  
Gift Card Storage 
All procedures will stay the same as written above. 
11. PROFESSIONALISM IN THE WORKPLACE 
Employees will follow University of Tennessee Policies, some of which are noted in this section. 
11.1. Professional Attire 
It is important that employees maintain a conservative, neat and clean appearance appropriate for 
the work environment. Preventive Medicine takes a “business casual” approach which includes 
suits, dress pants, dresses, and skirts, but may also include collared shirts, golf or “polo” shirts 
and pressed khaki pants.  
Attire that is not appropriate for the workplace includes t-shirts, tight or short pants/skirts, tank 
tops, halter tops, low-cut blouses or sweaters, or any extreme style or fashion in dress, footwear, 
accessories, or fragrances. Certain employees may be required to meet special dress, grooming 
and hygiene standards, such as wearing uniforms or protective clothing, depending on the nature 
of their job, which will be defined by the department. Some departments adopt casual or dress-
down days. In this instance employees are still expected to adhere to the aforementioned 
appearance but are not permitted to wear ripped, frayed clothing, disheveled clothing, work-out 
gear, tight clothing, revealing or otherwise workplace-inappropriate clothing is not permitted on 
any given day.  
11.2. Professional Behavior 

 
39 
 
11.2.1 Respect for Others 
People are the University of Tennessee’s most important resource for accomplishing its 
teaching, research, and public service missions. Accordingly, employees are expected to 
be committed to creating an environment that promotes academic freedom, diversity, fair 
treatment, and respect for others. Employees are expected to treat one another public in 
an honest and respectful manner. Specific examples of this behavior include disorderly 
conduct, including, but not limited to, using discriminatory, abusive, or threatening 
language; fighting, provoking a fight, or attempting bodily harm or injury to another 
employee or to any other individual or threatening physical action or injury on university 
property or during university activities; or other conduct that threatens or endangers the 
health, safety, or well-being of any person. 
11.2.2 Responsible Use of University Resources 
Employees must use university property, funds, technology, time, and other resources for 
legitimate business purposes. Employees must not use university resources for personal 
gain or to benefit third parties. These could include using university resources for 
personal needs, family matters, schoolwork, or abusing work time for any personal 
reasons. This also includes instigating or participating in deliberate low productivity 
and/or interfering with another employee’s work. 
11.2.3 Standards of Attendance and Timeliness  
SMART Project 3 employees are expected to be on time for work and on time for 
sessions. Employees should be clocked in and at their desk at their start time at the 
beginning of the day. Please note: Remote work still requires employee engagement 
during working hours, as designated.  
The university has policies on repeated tardiness and absences. Repeated tardiness is 
defined as arriving at work past the appointed starting time without supervisory approval. 
Other absences include the failure of employees to report to their work place at the 
beginning of the work period, leaving work before the end of the work period, and failure 
to inform the supervisor when leaving the work area. 
All appointments with participants should be started at the exact time scheduled, give or 
take 1 minute. If a staff member knows they will be more than 15 minutes late for a 
scheduled appointment, they should ask another staff member to call the participant and 
inform them that they are running late or to call and reschedule the participant. 

 
40 
12. MEASURES 
12.1. Table 1. List of Measures 
Measure 
Time to 
Complete 
(minutes) 
Baseline 
1,2, 4, 
and 8 
week 
sessions 
 
8 week 
blind 
Medical 
Chart at 
30 days 
Contact Information  
1 
X 
 
 
 
Referral source (how did they get to the CAS)? 
<1 
X 
 
 
 
Screening Questionnaire 
<1 
X 
 
 
 
Exclusion reason (if applicable) 
n/a 
 
 
 
 
Demographics (gender/race/ethnicity/education/zip 
code/insurance)  
3 
X 
 
 
 
Opioid Use Disorder (Diagnostic and Statistical 
Manual of Mental Disorders-5)93 interview 
1 
X 
 
 
 
Attended first physician visit 
n/a 
 
X 
 
 
Attended second physician visit 
n/a 
 
X 
 
 
Attended third physician visit 
n/a 
 
X 
 
 
Attended fourth physician visit 
n/a 
 
X 
 
 
Number of treatment visits attended (allow for drop 
out, drop back in): CUMULATIVE ADHERENCE 
n/a 
 
 
 
X 
Urine Toxicology (buprenorphine and all other 
substances) 
n/a 
X 
X 
 
X 
Timeline followback on alcohol, substance use, and 
opioid use 
3 
X 
X 
 
 
Delay Discounting58 
2 
X 
 
X 
 
Opioid Purchase Task46 
1 
X 
X 
 
 
Engagement in Substance Free Activities54 
2 
X 
 
X 
 
Time Spent On Activities 
2 
X 
 
 
 
Opioid Craving Symptoms95 (Opioid Cravings Scale) 
1 
X 
X 
 
 
Buprenorphine-Naloxone dose log (did you miss any 
days?) 
<1 
 
X 
 
 
Dosage of Buprenorphine-Naloxone Prescribed 
(obtained from medical record at each session ) 
n/a 
X 
X 
 
X 
Treatment Satisfaction 
4 
 
 
X 
 
Prescription Drug Monitoring data 
n/a 
X 
X 
 
X 
PEG for Chronic pain (3 items) 
<1 
X 
X 
 
 
EQ5D5L (6 items) Quality of life for cost-effectiveness 
analyses 
3 
X 
 
X 
 
PHQ-2 depression 2 items 
<1 
X 
X 
 
 
GAD 2 anxiety 2 items only (also a 7 item version) 
<1 
X 
X 
 
 
Treatment history (times in treatment, medication 
used) 
<1 
X 
 
 
 
Economy Contribution (3 items) 
<1 
X 
X 
 
 
If dropped out: Are you receiving but (or opioid 
replacement) treatment somewhere else? 
<1 
 
X 
 
 
Adverse Events 
<1 
 
X 
 
 
Participant time to complete all measures at sessions:  
 
20.5 
11 
10 
n/a 
 
 

 
41 
12.2. Measure Items (NIH REQUIREMENTS HIGHLIGHTED IN 
YELLOW) 
 11.2.1. Contact Information 
Patient 
 
Name:  
Last, First, MI 
Address: 
Include Apt # if applicable 
Zip Code (enter separately for NIH) 
XXXXX 
Phone 1 (cell): 
(xxx) xxx-xxxx 
Phone 2: 
(xxx) xxx-xxxx 
Email 1: 
 
Email 2: 
 
Preferred method of contact? 
Phone, text, email 
 
 
Emergency Contact 1 
 
Name:  
Last, First, MI 
Relationship: 
(spouse, family, friend) 
Address: 
Include Apt # if applicable 
Phone: 
(xxx) xxx-xxxx 
Email: 
 
 
 
Emergency Contact 2 
 
Name:  
Last, First, MI 
Relationship: 
(spouse, family, friend) 
Address: 
Include Apt # if applicable 
Phone: 
(xxx) xxx-xxxx 
Email: 
 
 
12.2.2. Referral source  
How did you get referred to the Center for 
Addiction Science? 
open-ended referral to be categorized later 
 
12.2.3. Screening Questionnaire 
 
Inclusion 
 
1. 
Presenting for their intake visit to the Center for Addiction 
Science for treatment of opioid use disorder 
Yes / No 
If no: Exclude 

 
42 
2.  Access to a telephone 
Yes / No 
If no: Exclude 
3.  Eligible for receipt of buprenorphine-naloxone medication (e.g., 
Suboxone, Bunavail, Zubsolv) 
Yes / No 
If no: Exclude 
4. 
Able to understand consent procedures 
Yes / No 
If no: Exclude 
 
Exclusion 
 
5. 
Have a known contraindication to buprenorphine-naloxone 
medication treatment for opioid use disorder 
Yes / No 
If yes: Exclude 
 
 
12.2.4. Exclusion reason (if applicable) 
Exclusion reason variable to be entered by staff 
for ease of access for DSMB report: 
List number of reason for exclusion from above 
screener. 
 
12.2.5. Demographics 
 
Date of Birth 
 xx/xx/xxxx 
Age 
 
Sex at Birth 
Male 
Female 
Gender Identity 
Male 
Female 
Other (enter what 
is said) 
 
 
Race 
 White/Caucasian 
Black/African 
American 
Multiracial 
Asian 
Alaskan Native 
Pacific Islander 
Native American  
Other (specify) 
 
Ethnicity 
 Non-hispanic 
Hispanic 
 
 
 
Highest level of education 
8th grade or less 
9th through 11th 
grade 
12th grade or 
GED 
Associate’s degree 
Vocational/trade 
school 
Some college 
Bachelor’s degree 
Graduate degree 
 
 
 
Less than $10,000 
per year 
$10,000 to $19,999 
per year 
$20,000 to 
$29,999 per year 

 
43 
 
 
Annual household income 
$30,000 to $39,999 
per year 
$40,000 to $49,999 
per year 
$50,000 to 
$59,999 per year 
$60,000 to $69,999 
per year 
$70,000 to $79,999 
per year 
$80,000 to 
$89,999 per year 
Over $100,000 per 
year 
Prefer not to answer 
 
Do you currently have a job? 
No 
Yes-part time 
Yes-full time 
Relationship Status 
Single 
Married 
Divorced 
Widowed 
Cohabitating 
 
What insurance do you use when you 
visit the Center for Addiction 
Science? 
(open-ended write in?) 
 
12.2.6. Opioid Use Disorder Criteria 
Diagnostic and Statistical Manual of Mental Disorders - 5 
Check all that apply: 
1. 
Are you often taking opioids in larger amounts or over a 
longer period of time than intended? 
 
2. 
Have you tried or been unable to cut down or control your 
opioid use? 
 
3. 
Have you spent a great deal of time in activities that are 
necessary to obtain your opioid, use the opioid, or recover 
from its effects? 
 
4. 
Do you have cravings, or a strong desire to use opioids? 
 
5. 
Is your opioid use resulting in failure to fulfill your role 
obligations at work, school or home? 
 
6. 
Have you continued to use opioids despite having persistent 
or recurrent social or interpersonal problems (caused or 
exacerbated by the effects of opioids)? 
 
7. 
Have you given up or reduced time spent of important social, 
occupational or recreational activities because of your opioid 
use? 
 
8. 
Have you used opioids in situations in which it is physically 
hazardous? 
 
9. 
Have you continued your opioid use despite physical or 
psychological problems that are caused or made worse by 
opioids? 
 
10. 
*Tolerance 
Do you need to use more and more opioids to achieve your 
high?   
or 
Do you get less of an effect from your opioid than you used 
to?   
 
11. 
*Withdrawal 
 

 
44 
Do you feel withdrawal when you don’t take opioids? 
or  
Do you take opioids to avoid feeling withdrawal? 
Have Filemaker autoscore: 
 
Total Number Boxes Checked: _________________ 
 
Severity designated: Mild: 2-3 symptoms. Moderate: 4-5 symptoms. Severe: 6 or more symptoms 

 
45 
12.2.7. Adherent for first follow up physician visit 
 
Showed up for Center for Addiction 
Science appointment at scheduled 
day/time? 
 Yes / No 
AND 
 
Had buprenorphine in urine screen (either 
at the visit or when urine specimen came 
back from lab)? 
 Yes / No 
If both items answered “Yes” then adherent is affirmed through Filemaker calculation 
 
 
12.2.8. Adherent for second physician visit 
 
Showed up for Center for Addiction 
Science appointment at scheduled 
day/time? 
 Yes / No 
AND 
 
Had buprenorphine in urine screen (either 
at the visit or when urine specimen came 
back from lab)? 
 Yes / No 
If both items answered “Yes” then adherent is affirmed through Filemaker calculation 
 
 
11.2.9. Adherent for third physician visit  
Showed up for Center for Addiction 
Science appointment at scheduled 
day/time? 
 Yes / No 
AND 
 
Had buprenorphine in urine screen (either 
at the visit or when urine specimen came 
back from lab)? 
 Yes / No 
If both items answered “Yes” then adherent is affirmed through Filemaker calculation 

 
46 
12.2.10. Adherent for fourth physician visit 
 
Showed up for Center for Addiction 
Science appointment at scheduled 
day/time? 
 Yes / No 
AND 
 
Had buprenorphine in urine screen (either 
at the visit or when urine specimen came 
back from lab)? 
 Yes / No 
If both items answered “Yes” then adherent is affirmed through Filemaker calculation 
 
 
12.2.11. Cumulative Adherence  
Number of treatment visits attended 
(allow for drop out, drop back in) 
Filemaker calculation 
 
11.2.12. Urine Toxicology  
Check all that are present in urine collected by Center for Addiction Science 
Buprenorphine 
Yes 
No 
THC 
Yes 
No 
Cocaine 
Yes 
No 
Opiates 
Yes 
No 
Amphetamines 
Yes 
No 
Methamphetamines 
Yes 
No 
 Phencyclidine (PCP) 
Yes 
No 
MCMA 
Yes 
No 
Barbiturates 
Yes 
No 
Benzodiazepines 
Yes 
No 
Methadone 
Yes 
No 
Tricyclic antidepressants 
Yes 
No 
Oxycodone 
Yes 
No 
ETC 
Yes 
No 
Fentanyl 
Yes 
No 
 
12.2.13. Timeline followback 
Today’s date: 
 
 
 
 
 
 
 
 
(fill in day 
of the 
week) 
(fill in 
day of the 
week) 
(fill in day 
of the 
week) 
(fill in 
day of the 
week) 
(fill in 
day of the 
week) 
(fill in 
day of the 
week) 
(fill in 
day of the 
week) 
 
(example) 
Monday 
(example) 
Tuesday 
(example) 
Wednesday 
(example) 
Thursday 
(example) 
Friday 
(example) 
Saturday 
(example) 
Sunday 
Did you have 
any illicit 
substances or 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 

 
47 
alcohol on ___ 
day? 
If yes to alcohol:  
Number of 
standard drinks 
on this day 
# drinks 
# drinks 
# drinks 
# drinks 
# drinks 
# drinks 
# drinks 
Marijuana on 
this day? 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Cocaine on this 
day? 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Crack on this 
day? 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Amphetamine 
or other 
stimulant on 
this day? 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Opioid drugs 
that weren’t 
prescribed to 
you? (not 
including 
fentanyl or 
methadone) 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Heroin on this 
day? 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Hallucinogens, 
including 
MDMA/ecstasy 
on this day? 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Sedatives and 
hypnotics, 
excluding 
Benzodiazepines 
on this day? 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Benzodiazepines 
on this day? 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Inhalants on 
this day? 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Fentanyl on this 
day? 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Methadone on 
this day? 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
Yes / No 
 

 
48 
12.2.14. Delay Discounting 
In this experiment you will be presented with two amounts of money to choose between. One of the 
amounts will be available now and the other will be available in the future. Your job is to indicate 
which option you would prefer by pressing "q" for the left option and "p" for the right option. 
 
You should indicate your true preference because at the end of the experiment a random trial will be 
chosen and you will receive a bonus payment proportional to the option you selected at the time point 
you chose. 
$54 today 
$55 in 117 days 
$55 today 
$75 in 61 days 
$19 today 
$25 in 53 days 
$31 today 
$85 in 7 days 
$14 today 
$25 in 19 days 
$47 today 
$50 in 160 days 
$15 today 
$35 in 13 days 
$25 today 
$60 in 14 days 
$78 today 
$80 in 192 days 
$40 today 
$55 in 62 days 
$11 today 
$30 in 7 days 
$67 today 
$75 in 119 days 
$34 today 
$35 in 186 days 
$27 today 
$50 in 21 days 
$69 today 
$85 in 91 days 
$49 today 
$60 in 89 days 
$80 today 
$85 in 157 days 
$24 today 
$35 in 29 days 
$33 today 
$80 in 14 days 
$28 today 
$30 in 179 days 
$34 today 
$50 in 30 days 
$25 today 
$30 in 80 days 
$41 today 
$75 in 20 days 
$54 today 
$60 in 111 days 
$54 today 
$80 in 30 days 
$22 today 
$25 in 136 days 
$20 today 
$55 in 7 days 
 

 
49 
12.2.15. Opioid Purchase Task 
Instructions 
The following questionnaire will ask you how many of your chosen opioids you would purchase 
depending upon how much they cost. Imagine that you will have to consume all purchases in a single 
day, you cannot stockpile or get the opioids from another source, and you have no opioids available 
from previous days. 
How many opioid pills would you purchase if 
they were:  
Number they would purchase: 
Free? 
 
$0.25 
 
$0.50 
 
$1 
 
$1.50 
 
$2 
 
$2.50 
 
$3 
 
$4 
 
$5 
 
$6 
 
$7 
 
$8 
 
$9 
 
$10 
 
$15 
 
$20 
 

 
50 
12.2.16. Engagement in Substance Free Activities 
Please rate the extent to which the following factors have been helpful in your recovery from 
opioids either currently or during periods in the past when you stopped using.   
Check or mark the box to indicate your answer. 
 
1 
Not at all 
helpful 
2 
Somewhat 
helpful 
3 
Very 
helpful 
 
 
√ 
 
1) Change in your social group to avoid drug users 
 
 
 
2) Increasing your social support, making new friends  
 
 
 
3) Developing a new hobby or reinvesting in previous hobbies 
(e.g., hunting, fishing, gardening) 
 
 
 
4) Exercising  
 
 
 
5) Running   
 
 
 
6) Reading  
 
 
 
7) Participating in yoga, meditation, or other forms of 
relaxation  
 
 
 
8) Spending more time with your family  
 
 
 
9) Change in your employment situation (working more or 
changing your job) 
 
 
 
10) Spending time in nature  
 
 
 
11) Addressing relationship or family issues/conflict 
 
 
 
12) Private religious activity (praying, meditating, reading 
scripture or religious books) 
 
 
 
13) Attending religious services  
 
 
 
14) Finding new ways to manage pain  
 
 
 
15) Taking medication for depression or anxiety  
 
 
 
16) Changing your diet to eat healthier foods  
 
 
 
17) Engaging more with social media (e.g., Facebook) 
 
 
 
18) Engaging less with social media (e.g., Facebook) 
 
 
 
19) Cooking/baking 
 
 
 
20)  Changing your living situation/moving 
 
 
 
21) Drinking less alcohol or quitting drinking altogether 
 
 
 
22) Using less marijuana or quitting marijuana use altogether  
 
 
 
23) Quitting smoking  
 
 
 
24) Using more alcohol  
 
 
 
25) Using more marijuana  
 
 
 
26) Smoking more 
 
 
 
27)  Engaging in creative activities (music, art, etc.) 
 
 
 
28) Getting involved with a team sport 
 
 
 
29) Getting involved in a community organization  
 
 
 
30) Volunteering  
 
 
 

 
51 
31) Getting a pet 
 
 
 
32) Participating in a 12-step or other support group  
 
 
 
33) Seeing a professional counselor/therapist  
 
 
 
34) Helping others   
 
 
 
35) Taking a college class or educational/training program  
 
 
 
36) Sexual activity  
 
 
 
37) Eating more 
 
 
 
38) Addressing a health issue 
 
 
 
39) Avoiding high-risk situations for use/relapse 
 
 
 
40) Limiting access to money  
 
 
 
41) Telling your friends about your plan to stop using  
 
 
 
42) A change in your financial situation  
 
 
 
43) Reminding yourself about the risks of using  
 
 
 
44) Increasing your self-confidence/self-esteem  
 
 
 
45) Practicing positive self-talk (e.g., “I’m a good person” or “I 
can do this without pills”) 
 
 
 
46) Managing anger 
 
 
 
47) Other (write in) 
 
 
 
 
 
12.2.17. Time Spent on Activities Worksheet (to be uploaded as picture to database). 
 
Instructions: 
Please list how many hours EACH WEEK you spend doing each of the activities 
listed below.  
For example, if you spend 2 hours each day playing video games, that would be 
14 hours each week for the activity named “Watching TV or surfing the internet.”  
 
How many 
hours do you 
spend doing 
this activity 
EACH 
WEEK? 
Family 
 
Work 
 

 
52 
Education, hobbies, creative activities 
 
Exercise, time in nature, or self-care 
 
Watching TV or surfing the internet 
 
Religious or spiritual activity, community life 
 
Using opioids or other drugs/alcohol 
 
Substance recovery/treatment (includes counseling/medication visits 
and time in meetings like AA or NA) 
 
Socializing with people who are supportive of your recovery 
 
Socializing with people who are not supportive of your recovery 
 
 
 
12.2.18. Opioid Cravings Scale 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
1. How much do you currently 
crave opiates? 
Not 
at all 
 
 
 
 
 
 
 
 
 
Extremely 
2. In the past week, please rate 
how strong your desire to use 
opiates has been when 
something in the environment 
has reminded you of opiates 
No 
desire  
 
 
 
 
 
 
 
 
 
Extremely 
strong 
3. Please imagine yourself in 
the environment in which you 
previously used opiates. If you 
were in this environment 
today and if it were the time of 
day that you typically used 
opiates, what is the likelihood 
that you would use opiates 
today? 
Not 
at all 
 
 
 
 
 
 
 
 
 
I'm sure I 
would use 
opiates 

 
53 
12.2.19. Buprenorphine-Naloxone dose log 
How many days since your last visit to the Center 
for Addiction Science? 
Enter # 
How many days during this period did you skip 
your buprenorphine dose? 
 
 
12.2.20. Dosage of Buprenorphine-Naloxone Prescribed  
(obtained from medical record at each session ) 
Medication name 
 
Mg prescribed (buprenorphine) 
 
MME calculation 
 
 
12.2.21. Treatment Satisfaction 
 
 
 The person who presented the material: 
 
 
 
 
 
1. 
Was easy to talk to. 
Strongly 
Disagree 
Somewhat 
Disagree 
Neutral 
Somewhat 
Agree 
Strongly 
Agree 
2. 
Was concerned about me. 
Strongly 
Disagree 
Somewhat 
Disagree 
Neutral 
Somewhat 
Agree 
Strongly 
Agree 
3. 
Understands me. 
Strongly 
Disagree 
Somewhat 
Disagree 
Neutral 
 
Somewhat 
Agree 
Strongly 
Agree 
4. 
Seemed competent and well trained. 
Strongly 
Disagree 
Somewhat 
Disagree 
Neutral 
Somewhat 
Agree 
Strongly 
Agree 
5. 
Seemed well organized. 
Strongly 
Disagree 
Somewhat 
Disagree 
Neutral 
Somewhat 
Agree 
Strongly 
Agree 
6. 
Gave me the opportunity to express my thoughts 
about treatment. 
Strongly 
Disagree 
Somewhat 
Disagree 
Neutral 
Somewhat 
Agree 
Strongly 
Agree 
7. 
Helped me believe that I can change my opioid use 
if I want to. 
Strongly 
Disagree 
Somewhat 
Disagree 
Neutral 
Somewhat 
Agree 
Strongly 
Agree 
8. 
Argued with me. 
Strongly 
Disagree 
Somewhat 
Disagree 
Neutral 
Somewhat 
Agree 
Strongly 
Agree 
9. 
Tried to convince me that I needed to change my 
behavior. 
Strongly 
Disagree 
Somewhat 
Disagree 
Neutral 
Somewhat 
Agree 
Strongly 
Agree 
10. Made me feel that it is up to me to make decisions 
about staying in treatment. 
Strongly 
Disagree 
Somewhat 
Disagree 
Neutral 
Somewhat 
Agree 
Strongly 
Agree 
11. Gave me the chance to ask questions. 
Strongly 
Disagree 
Somewhat 
Disagree 
Neutral 
Somewhat 
Agree 
Strongly 
Agree 
 
 
The next questions are related to your treatment, not your counselor. 
12. How interesting did you find this treatment? 
Totally 
bad, boring 
OK 
 
Excellent, 
it was great 
 
13. How personally relevant did you find this 
treatment? 
Not at all 
relevant to 
me 
OK 
 
Excellent, 
it was very 
relevant to 
me 
 
14. How effective do you think this treatment was 
in helping you stay in treatment? 
Not at all 
effective 
Somewhat 
effective 
 
Very 
Effective 
 

 
54 
15. 
Those who drop out of treatment only: Please 
indicate how likely you are to restart 
buprenorphine treatment in the near future 
I will not 
change my 
smoking 
Unsure 
 
I will 
change my 
smoking 
N/A, 
already 
quit 
16. 
How effective, overall, do you think this 
program will be in helping people stay in 
opioid treatment? 
 
1 = Not useful or effective 
 
10 = Highly effective. The best treatment I could 
imagine. 
17. What components of the treatment were most 
effective for you? 
 
(Open ended) 
18. Can you think of any ways to make this 
intervention more effective and user-friendly? 
 
(Open ended) 
19.  
What initially made you want to enroll in the 
study? 
 
a.  
b. I wanted help staying in treatment 
c. Gift cards 
d. One-on-one counseling 
e. Other (specify) 
 
20. 
What was your motivation to stay in the study 
and complete your sessions? 
 
 
(Open ended) 
 
12.2.22. Prescription Drug Monitoring data 
 
Number of opioid prescriptions found in the 
prescription drug monitoring database since last 
visit 
# 
 
12.2.23. PEG for Chronic pain (3 items) 
 
0 
No Pain 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Pain as bad as 
you can imagine 
What number best describes your pain 
on average in the past week? 
0 
No Pain 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Pain as bad as 
you can imagine 
What number best describes how, during 
the past week, pain has interfered with 
your enjoyment of life? 
0 
No Interference with 
Enjoyment 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Completely 
Interfered with 
Enjoyment 
What number best describes how, during 
the past week, pain has interfered with 
your general activity? 
0 
No Interference with 
Activity 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Completely 
Interfered with 
Activity 

 
55 
12.2.24. EQ 5D 5L 
Descriptive System items: 
Instructions: Select the answer that best applies to you 
Answer score: 
1 
2 
3 
4 
5 
MOBILITY 
I have no 
problems in 
walking 
around 
I have slight 
problems in 
walking 
around 
I have 
moderate 
problems in 
walking 
around  
I have severe 
problems in 
walking 
around 
I am unable 
to walk 
around 
SELF-CARE 
I have no 
problems 
washing or 
dressing 
myself 
I have slight 
problems 
washing or 
dressing 
myself 
I have 
moderate 
problems 
washing or 
dressing 
myself 
I have severe 
problems 
washing or 
dressing 
myself 
I am unable 
to wash or 
dress myself 
USUAL 
ACTIVITIES 
(e.g. work, study, 
housework,family 
or leisure 
activities) 
I have no 
problems 
doing my 
usual 
activities 
I have slight 
problems 
doing my 
usual 
activities 
I have 
moderate 
problems 
doing my 
usual 
activities 
I have severe 
problems 
doing my 
usual 
activities 
I am unable to 
do my usual 
activities 
PAIN / 
DISCOMFORT 
I have no 
pain or 
discomfort 
I have slight 
pain or 
discomfort 
I have 
moderate 
pain or 
discomfort 
I have severe 
pain or 
discomfort 
I have 
extreme pain 
or discomfort 
ANXIETY / 
DEPRESSION 
I am not 
anxious or 
depressed 
I am slightly 
anxious or 
depressed 
I am 
moderately 
anxious or 
depressed 
I am severely 
anxious or 
depressed 
I am 
extremely 
anxious or 
depressed 
 
VAS scale item 
Instructions:  
We would like to know how good or bad your health is today.  
This scale is numbered from 0 to 100. 
100 means the BEST health you can imagine. 
0 means the WORST health you can imagine. 
From 0 to 100, how good is your health today? 
Score (0 to 100):  

 
56 
12.2.25. PHQ-2 depression 2 items 
Instructions: Over the last 2 weeks, how often have you been bothered by the following problems? 
Score: 
0 
1 
2 
3 
1. Little interest 
or pleasure in 
doing things 
Not at all 
Several days 
More than half 
the days 
Nearly every day 
2. Feeling down, 
depressed or 
hopeless 
Not at all 
Several days 
More than half 
the days 
Nearly every day 
 
12.2.26. GAD 2 anxiety 2 items only (also a 7 item version) 
Instructions: Over the last 2 weeks, how often have you been bothered by the following problems? 
Score: 
0 
1 
2 
3 
1. Feeling 
nervous, anxious 
or on edge 
Not at all 
Several days 
More than half 
the days 
Nearly every day 
2. Not being able 
to stop or control 
worrying 
Not at all 
Several days 
More than half 
the days 
Nearly every day 
 
12.2.27. Treatment history (times in treatment, medication used) 
How many times have 
you been in treatment for 
opioid use disorder 
(addiction)? 
(fill in number) 
 
If “0”, end this questionnaire. 
Treatment #1 (most 
recent) 
 
 
 
How long were you in 
treatment (months)? 
(fill in number of months) 
Was this counseling, 
medication, or both? 
Counseling 
Medication 
Counseling and 
Medication 
Was it successful (were 
you able to stop using 
opioids)? 
Yes / No 
Treatment #2 
 
 
 
How long were you in 
treatment (months)? 
(fill in number of months) 
Was this counseling, 
medication, or both? 
Counseling 
Medication 
Counseling and 
Medication 
Was it successful (were 
you able to stop using 
opioids)? 
Yes / No 
Treatment #3… etc. up to 
5 only 
 
 
 
 

 
57 
12.2.28. Economy Contribution Questions  
1. 
Are you working? 
Yes 
No 
 
If yes 
1.a.  
How many hours a week? 
 
1.b. 
How much do you make an hour? 
 
1.c. 
How long have you been with your current 
employer? 
 
2. 
Are you receiving SNAP/TANIF/SSDI/other 
public assistance? 
Yes 
No 
3. 
Have you had any police contact since last 
session ? 
Yes 
No 
 
12.2.29. For Participants Who Have Stopped Center for Addiction Science 
Treatment Only 
Are you receiving buprenorphine-naloxone 
treatment from a different provider at this time? 
Yes / No 
Are you receiving any treatment for opioid use 
disorder at this time? 
Yes / No 
 
12.2.30. Adverse Events 
What was the adverse event? _________________________________________________________ 
 
Onset Date: ____ / ____ / ____ 
 
End Date: ____ / ____ / ____ 
 
Was the participant using the study drug(s) at the time of the event?  
o Yes 
o No 
 
Was the event related to the study intervention or study drug?  
o Unrelated 
o Unlikely 
o Possible 
o Probable 
o Highly Probable  
 
Action Taken:  
o None 
o Study Drug Paused 
o Study Drug Discontinued 
o Study Participation Paused 
o Study Participation Ended 
 
If study participation was stopped, was it stopped due to the AE?  
o Yes 
o No 
o N/A 
 
Was the event expected? 

 
58 
o Yes 
o No 
 
Severity of AE:  
o Mild 
o Moderate 
o Severe 
 
SAE Category: 
o Not an SAE 
o Inpatient hospitalization  
o AE resulted in death 
o Life threatening 
o Permanent or severe disability  
o Congenital anomaly 
o Treatment to prevent an above serious event 
 
Outcome:  
o Completely recovered 
o Recovered with sequalae 
o Condition improving 
o Condition present and unchanged 
o Condition deteriorated  
o Death due to this AE 
o Other 
______________________________________________________________________________
______________________________________________________________________________ 
 
Narrative/Comments:  
______________________________________________________________________________
______________________________________________________________________________ 
______________________________________________________________________________
______________________________________________________________________________ 
______________________________________________________________________________ 
 
Staff Initials: ________ 
 
 
 
 
MD Check Off Initials ________ 
 
Date: ____ / ____ / ____ 
 
 
o Approved 
o Needs QC 
 
MD Additional Information Needed:  
______________________________________________________________________________
______________________________________________________________________________ 
______________________________________________________________________________
______________________________________________________________________________ 
 
QC Completed By ________ 
QC Date: ____ / ____ / ____ 
MD CHECK OFF SECTION

 
59 
12. CM INTERVENTION SCRIPT 
 
Hi _________. Nice to see you again. As you may remember, we check on your toxicology results to 
determine whether you are eligible for the number wheel.  
 
Buprenorphine Present: 
I see today you do have medication in your system. Congratulations! You are eligible for the wheel spin. 
As a reminder, the wheel includes gift cards ranging from $25 to $100. You will spin and land on a 
random number.  
https://pickerwheel.com/ 
 
Buprenorphine Not Present:  
I see today you do not have medication in your system. I’m sorry, but you will not be eligible for the 
wheel spin today. 
 

 
60 
13. BSM INTERVENTION SCRIPT 
Psychosocial Intervention Session 1 (40 minutes with assessments):   
 
Session Prep:  
a. Ensure participant has received SOBER Handout at baseline 
b. Print off blank Goals worksheet for Session 1 to fill out during session 
c. Participant should have completed the “Time Spent on Activities Worksheet” at baseline. 
i. 
Have a graph of the time spent in each activity prepared and sent to the participant 
before the session begins 
d. Print off blank Future Event Description worksheet for Session 1 (Goals, Future Event 
Description) to fill out during session  
1. Introduction (2 minutes)  
a. Getting Permission to Record  
i. Hi _____, is this still a good time for us to do our first session together? 
Great!  
ii. Before we get started today, I wanted to let you know all of our sessions 
will be recorded for the purpose of the study.  
iii. Do I have your permission to record this session? Thank you so much.  
b. Mandated reporting  
i. Also, I wanted to let you know that I am a mandated reporter. That means 
if you let me know about any ongoing abuse, either to yourself or to 
someone else, or if you inform me of any intentions to harm yourself or 
someone else, I am obligated by law to report that. If anything like that 
comes up during any of our sessions, I would let you know ahead of time.  
ii. Do you have any questions about that?  
 
2. Assessment (10 minutes)  
a. Complete session one assessment forms in FileMaker.  
b. Thank you for taking the time to answer all those questions. 
c. Because you finished your assessment, I will mail you that $25 gift card. Do you 
prefer Kroger or Walmart? Great!  
d. Please allow 2-3 business days for it to arrive. If there are any issues, please 
don’t hesitate to reach out!  
 
3. Build Rapport (1 minutes) 
a. So I’d like to get to know a little more about who you are. Tell me who are the 
most important people in your life and one or two things you like to do – just a 
minute’s worth of who you are. 
i. Wait for participant to tell you about themselves – MAXIMUM 1 minute 
 
4. Orientation to Session (1 minute) 
a. Thank you for telling me about yourself. 
b. Let me tell you about what we will be doing with our time together. 
i. My overall goal is to support your treatment at the Center for Addiction 
Science and help you meet your goals.  
ii. During our 4 sessions together, we will discuss your goals and values, 
identify some drug and alcohol free activities you would like to start doing, 
and teach you some relaxation skills.  
c. Do you have any questions before we start?  

 
61 
i. Answer questions 
 
5. Goals for Treatment/Motivational Interviewing Discussion (5 minutes) 
a. Have blank “Goals Worksheet” printed out and ready to use 
b. Introduce Purpose 
i. Now first, I want to talk about your goals, both short and long term. This is 
to help you start to expand your thinking into the future. 
ii. Why did you decide to start treatment that this time? 
1. Things they want to accomplish as a result of being in treatment 
c. Discuss Goals 
i. Thank you for sharing that with me. 
ii. Now, what are your overall life goals? What would you like to 
accomplish?  
1. Listen and reflect. 
2. Summarize the goals they tell you.  
3. Help them to identify at least one goal that might lead to an 
increase in positive drug-free activities. Many participants will 
naturally bring up a goal that will serve this purpose (e.g., getting 
in shape, meeting new people, getting a new job, improving family 
relationships). If they do not, you can ask them if they can think of 
a goal that would enrich their life in some way by enhancing their 
social support, enjoyment, or giving them a sense of 
accomplishment or purpose?     
4. OK, great, so you would like to ________ and ____ and ______ .  
d. Possible activity: Choose Goal and Break Down into Small Steps.  
i. Note: Only ask them to break down a goal into smaller steps if you think 
that would lead to increases in positive drug-free activities.   
ii. Now let’s choose one of those goals and really think about what it will 
take to reach it. How about X (goal that can lead to increased drug free 
activities) 
1. Sometimes, breaking a goal down into smaller steps helps you get 
started on it. 
2. Write goal on the “Goals” worksheet (see separate page, below). 
iii. Now let’s list some short-term, specific things you need to do that will help 
you to reach your goal. 
1. Keep asking open-ended questions to identify 3 very specific 
behaviors. 
e. Summarize 
i. OK, so I have that your big goal is to _____, and you will get there by 
doing ____, _____, and _____. Does that sound right? 
ii. Now I would like to ask you, how might relapse impact this goal? 
1. Let them answer 
2. I see, so relapse would make it difficult to ____, but if you stay in 
treatment, this goal might be reachable. 
iii. I’m going to text you this worksheet I filled out so you can reflect on these 
steps we talked about and also fill in the steps for the other two goals you 
identified 
iv. Send this list to the participant via text or email (if using social distancing 
procedures) 
 
6. Time Spent On Activities of Daily Life (5 minutes) 
a. Participant should have completed the “Time Spent on Activities Worksheet” at 
baseline. 

 
62 
b. Graph participant’s time spent in each activity prior to session, and hand it, text it, 
or email it to the participant. Their answers should be in the baseline assessment 
in filemaker. 
c. Have this graph in front of you for this activity. 
d. Introduce Activity 
i. Let’s change gears now and talk about the activities that are important to 
you in life; your priorities and core goals for yourself.   
1. You may remember that when you first came in, we asked you to 
fill out a questionnaire about how many hours per week you spend 
doing different things. 
2. I took what you wrote, graphed it out, and gave it to you before our 
session today.  
ii. Now, if it’s okay with you, I’d like to talk about these activities.  
1. One of the reasons we summarize this information is because 
people rarely think about how they spend their time, even though 
it says a lot about what they find important.  
iii. So, looking across this graph at the time you spend doing different things, 
what stands out to you? 
iv. What are some areas that you might like to change the amount of time 
you spend on them? 
e. FOR THOSE WITHOUT ACCESS TO THE GRAPH 
i. Since you can’t see the graph, let’s walk through a few areas. 
ii. You stated that you spend ____ hours a week with your family.  
1. How do you feel about that when you think about your goals? 
iii. You spend _____ hours a week on work.  
1. How do you feel about that when you think about your goals? 
iv. You spend _____ hours a week on education, hobbies, or creative 
activities.  
1. What kinds of things do you do? 
2. How do you feel about the amount of time you spend on this when 
you think about your goals? 
v. You spend _____ hours a week on exercise, time in nature, or self-care.  
1. What do you think about your time spent on these activities when 
you think about your goals? 
vi. You spend ____ hours a week watching TV or surfing the internet.  
1. What do you think about your time spent on these activities when 
you think about your goals? 
vii. You spend ____ hours a week on religious or spiritual activity, community 
life.  
1. How do you feel about that when you think about your goals? 
viii. You spend ____ hours a week using opioids or other drugs/alcohol.  
1. How do you feel about that when you think about your goals? 
ix. You spend ____ hours a week on substance recovery and treatment.  
1. What do you think about your time spent on recovery activities 
when you think about your goals? 
x. You spend ______ hours a week socializing with people who are 
supportive of your recovery.  
1. What do you think about your time spent doing this when you think 
about your goals? 
xi. You spend _____ hours a week socializing with people who are not 
supportive of your recovery.  
1. What do you think about your time spent doing this when you think 
about your goals? 

 
63 
f. Summarize: 
1. So it sounds like you would like to spend more time ____ and also 
_____ because that fits with your goals of _____ and _____. 
2. What would keep you from changing how you spend your time?  
7. Future Events (10 minutes) 
a. Have blank “Future Event Description Worksheet” ready to use 
b. Prepare Think Activity 
i. Now let’s do a short thinking exercise. I am going to ask you to think 
specifically about positive (nice, happy) future events that could happen if 
you remain in recovery.  
1. If you are comfortable, you may close your eyes for a moment so 
that you can focus.  
2. Visualize your life 3 months into the future. 
ii. Think about aspects of your life that matter to you.  
1. It could be how you want to grow mentally, spiritually, or 
physically. Think about how you would want your body and 
physical fitness to be, or what new skills or hobbies you may want 
to learn, or what new career building skills you would want to 
develop, or anything that gives you a sense of meaning, mission, 
or purpose.  
iii. Pick any of these categories that are important in your life and take a 
minute to visualize and imagine how will feel in your life 3 months from 
today.  
1. Wait about 60 seconds to let the person imagine this future event. 
c. Describe Activity 
i. Now, let’s talk about a specific type of positive (nice, happy) experience 
you are looking forward to having in your life. 
2. I want you to be specific about what you will be doing, who you 
will be with, how you imagine this one experience will feel, and the 
types of thoughts and emotions you have when this event takes 
place. 
3. Tell me about the future event (or events) you imagined. 
ii. Write down and summarize for patient. 
1. So, if you remain in recovery, you are looking forward to ______, 
with ________, and this will feel __________. Did I get that right? 
2. That’s really something to look forward to. 
 
8. Mindfulness-Based Adherence Promotion Intervention (5 minutes) 
a. The last thing we’ll discuss today is something called the SOBER breathing 
space. We’re going to go over this in more detail in the weeks to come, but I want 
you to have an idea of what it is to help you start working through some of your 
triggers.  
b. Explain the Acronym 
i. SOBER stands for:  
1. Stop and see what happens 
2. Observe physical sensations and emotion regulation changes in 
the body 
3. Breathe by deliberately bringing attention to the breath  
a. Describe to the participant how to breathe in through their 
nose and out through their mouth slowly.  
4. Expand awareness of the situation  
5. Respond mindfully (versus reacting) 

 
64 
c. Give/Send participant SOBER Handout 
i. I’m sending you a handout with the SOBER skillset so that you can start 
using this at home. 
d. Trigger identification 
i. Is there a trigger that you’re worried could come up this coming week? 
1. i.e., something that reminds them of opioid (or other drug) use.  
ii. This coming week, if ______ comes up, what would it be like to take a 
few minutes to SOBER?  
 
9. Wrap-Up (1 minute) 
a. We talked about a lot today. I appreciate your openness.  
b. To summarize:  
i. It seems like you are motivated to spend more time on _____ given how 
important it is for you.  
ii. From all the information we covered today, I’m curious about what stands 
out most for you? 
i. Allow participant to answer. 
c. Do you have any questions for me?  
d. Let’s schedule our next session  together, based around your clinic visit.   
e. Provide participant with date and time of session.  
 
What to send to participant after Session #1: 
1. Completed “Goals Worksheet” 
2. Gift Card for completed assessment 
 
Upload into Database after Session #1: 
1. Completed “Goals Worksheet” 

 
65 
Goals Worksheet 
List participant’s goals. If useful, break down goal into smaller steps.  
Following the session, upload this as a picture into the database under session 1 tab. 
 
 
 
Goal 
Short term, 
specific goals 
1.  
1.  
2.  
3.  
2. 
 
 
1.  
2.  
3.  
3. 
1.  
2.  
3.  

 
66 
Time Spent on Activities Worksheet (uploaded at baseline as picture to database) 
 
Instructions: 
Please list how many hours EACH WEEK you spend doing each of the activities 
listed below.  
For example, if you spend 2 hours each day playing video games, that would be 
14 hours each week for the activity named “Watching TV or surfing the internet.”  
 
How many 
hours do you 
spend doing 
this activity 
EACH 
WEEK? 
Family 
 
Work 
 
Education, hobbies, creative activities 
 
Exercise, time in nature, or self-care 
 
Watching TV or surfing the internet 
 
Religious or spiritual activity, community life 
 
Using opioids or other drugs/alcohol 
 
Substance recovery/treatment (includes counseling/medication visits 
and time in meetings like AA or NA) 
 
Socializing with people who are supportive of your recovery 
 
Socializing with people who are not supportive of your recovery 
 
 

 
67 
Example Graph of Time Spent on Activities Worksheet 
0
5
10
15
20
25
30
35
40
45
50
Family
Work
Education, hobbies, creative activities
Exercise, time in nature, or self-care
Watching TV or surfing the internet
Religious or spiritual activity, community life
Using opioids or other drugs/alcohol
Substance recovery/treatment
People who are supportive of your recovery
People who are not supportive of your recovery
Hours per Week Spent
Activities

 
68 
Future Event Description Worksheet 
Write event below to summarize for the participant. 
 
 
 
 
 
 
 
 
Following the session, upload this as a picture into the database under session 1 tab. 
 
 

 
69 
SOBER Handout  
Handout is to be given to the participant at their baseline visit.  
 
 
 
 

 
70 
Psychosocial Intervention Session 2 (39 minutes with assessments):  
 
Session Prep:  
a. Goals Worksheet from session 1 that you filled out for the participant. 
b. Participant’s completed Substance Free Activities Worksheet (from Baseline 
Assessment) 
o Look over participant’s preferred substance free activities questionnaire from 
baseline. 
o Identify activities local to the participant’s home or available online that could 
fulfill these activity needs. 
o Focus more on increasing activities that include socializing with people 
supportive of recovery, exercise/time outdoors, and goal-directed/creative 
activities.  
o Focus less on activities that might jeopardize recovery (time with users, 
activities that increase stress) or that are recovery neutral (passive leisure 
activities like watching TV) those should be less of a focus  
§ 
In the case of risky activities, the clinician can ask the client how that 
activity would relate to their recovery goals – get the participant to make 
this link. 
c. ***during pandemic*** Pleasant Activities handout 
 
1. Introduction (1 minute)  
a. Getting Permission to Record  
i. Hi _____, how are you today? Is this still a good time for us to do our 
second session together? Great! And before we get started today, do I 
have your permission to record this session? Thank you.   
 
2. Assessment (10 minutes)  
a. Complete session two assessment forms in FileMaker.  
b. Because you finished your assessment, I will mail you that $25 gift card. Do you 
prefer Kroger or Walmart? Please allow 2-3 business days for it to arrive. Thanks 
for getting the assessment completed today.  
 
3. Continue to Build Rapport (2 minutes) 
a. Tell me how you’ve been since the last time we spoke.  
b. Wait for participant to tell you how they are. 
 
4.  Orientation to Session (1 minute) 
a. Today we are going to build on what we discussed last time by discussing your 
activities, and revisiting the SOBER breathing exercise. 
b. What questions or thoughts do you have about our last session?  
c. If the participant missed the previous session , take a few moments to inform 
them of the information they missed.  
 
5. Goal Setting Exercise (5 minutes) 
a. Have completed “Goals Worksheet” available from Session 1 
b. To start today, I’d like to revisit your goals from session 1.  
c. Restate Goals 
i. During session 1, you mentioned that this was your primary goal:  
1. (read their primary goal from worksheet) 

 
71 
2. Has this goal changed?  
3. Have you had the opportunity to work towards this goal in the past 
week?  
a. “No” is an acceptable answer.  
b. Normalize that their goal right now may be “survival” and 
that’s ok 
d. Benefits and Barriers 
i. Let’s talk more about the goal you identified. 
1. What would be the benefits of achieving this goal?  
2. What do you think might get in the way? 
ii. A goal that may seem completely appropriate may have some unforeseen 
barriers  
e. Tracking progress and organizing activities with an app or calendar: 
i. Finally, I would like to ask you how you keep track of what activities you 
have planned? 
ii. Do you use any sort of calendar?  
1. Some people find it helpful to write down activities in your calendar 
ahead of time.  
a. What do you think about this? 
2. If they are agreeable: 
a. Do you like a written calendar or use of a device, like a 
smartphone phone? 
b. Briefly summarize their thoughts on this (example: ok, so you 
might consider using the calendar on your phone to keep 
track of your activities). 
 
6. Substance Free Activity: Identifying Activities (7 minutes) 
a. Have participant’s completed Substance Free Activities Worksheet (from 
Baseline Assessment) available 
b. Orient participant to topic 
i. Let’s move to a new subject now. 
ii. Many people who decide to make a change in their drug use find that 
developing other ways of having a good time, in order to fill the void left 
by drug or alcohol use, is a crucial part of their recovery.  
c. Review their answers to the substance free activities worksheet 
i. When you enrolled in the study, you completed a list of substance free 
activities that you enjoyed or found important to your recovery  
1. These are the activities you ranked the HIGHEST 
a. Which of these activities/hobbies do you enjoy the most?  
b. Write down activities participant enjoys the most 
2. What do you like about _(the activities they mention)_____? 
a. Talk through a few activities, focusing on exercise, 
socializing with non-users, and goal-directed, creative 
activities. 
3. What are some of the reasons you want to focus on ___(the 
activities they mention)___? 
a. Talk through each activity they listed (limit this to 5 
activities or less) 
4. What are some of the things that could get in the way of enjoying 
these activities? 
a. For people who report few enjoyable activities help them to 
problem solve how they could access more activities.   
 

 
72 
7. Increasing Substance Free Activities (7 minutes) 
a. Orient participant to topic 
i. Now let’s talk about taking some steps to increase your drug free 
activities. 
ii. Your preferred activities are ___(list from above)____________ . 
1. What are some realistic steps you can start to take to implement 
this into your life more often?  
2. How would ________ activity fit in with your recovery plan?   
b. Tell them what you found for them 
i. Great! To help you learn about some of these activities you mentioned 
last week, I have put together some information on how you can get 
involved in some of these activities in your community.  
1. Encourage the participant to ask questions and take a few 
moments to explain the specific resources you provided (e.g., 
“You talked a lot about spending time with animals as a helpful 
tool in your recovery. Did you know that the Humane Society of 
Memphis is always looking for volunteers or foster homes for 
animals? Here is their information.” 
ii. What are your thoughts in contacting one or two of these places next 
week (or doing these activities)?  
1. Write down plan on the Session 2 Substance Free Activities Plan 
worksheet.  
2. If the participant does not express any motivation to incorporate 
substance-free activities into his/her life, the interventionist should 
focus on fostering ambivalence in the participant about his/her 
current time allocation. The interventionist should explore with the 
participant the pros and cons of continuing to allocate his/her time 
in this manner.  
3. The interventionist could also try to help the participant in 
considering more long-term goals if they are ambivalent with 
short-term.  
4. If there are barriers to participating in the substance free activities, 
the interventionist should help the participant problem solve ways 
to get involved in said substance-free activities.  
c. Pleasant Activities Worksheet 
i. Give worksheet to participant. 
ii. Lots of folks are having trouble finding ways to manage their stress during 
COVID. Here is a handout with a list of relaxing activities people can do at 
home.  
iii. Some of these may work for you, others may not. It is really to help you 
identify some strategies you can use, even when life isn’t normal. 
d. Wrap Up 
i. It sounds like you’ve put a lot of thought into how you would like to use 
your time. We can continue to talk about this next time. 
ii. I am going to send you this worksheet after our session today. 
iii. Send to participant following session 
 
8. Mindfulness-Based Adherence Promotion Intervention (5 minutes) 
a. Before we wrap up our time together today, let’s talk a little more about the 
SOBER acronym we discussed last time. How has SOBER been working for 
you?  
iv. Remind the participant of the SOBER acronym if needed (Stop, Observe, 
Breathe, Expand, and Respond).  

 
73 
 
9. Wrap-Up (1 minute) 
a. We covered a lot today during our session. Do you have any questions for me?  
b. Let’s schedule our next session together. 
c. Provide participant with date and time of session.  
 
 
What to send to participant after Session #1: 
1. Completed “Substance Free Activities Plan Worksheet” 
2. Gift Card for completed assessment 
 
Upload into Database after Session #1: 
1. Completed “Substance Free Activities Plan Worksheet” 

 
74 
2. Session 2: Substance Free Activities Plan Worksheet  
 
 
 
 
Substance Free Activity 
Steps to start this activity 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
75 
Psychosocial Intervention Session 3 (41 minutes with assessments):   
Session Prep:  
• 
Have participant’s Substance Free Activities Plan Worksheet available from session 
2. 
 
 
1. Introduction (1 minute)  
a. Getting Permission to Record  
b. Hi _____. Is this still a good time for us to do our next session together? Do I 
have your permission to record this session? Thank you!   
 
2. Assessment (10 minutes) 
a. Complete session three assessment forms in FileMaker. 
b. Because you finished your assessment, I will mail you that $25 gift card. Do you 
prefer Kroger or Walmart? Please allow 2-3 business days for it to arrive.  
 
3. Continue to Build Rapport (2 minutes) 
a. How have you been doing since we last spoke? 
a. Wait for participant to answer. 
 
4.  Orientation to Session (1 minute) 
a. Today, we are going to review the opioid-free activities you’ve been trying, and 
have a discussion about the deeper meaning of the SOBER breathing exercise.  
b. What questions or thoughts do you have about our last session? 
c. If the participant missed the previous session , take a few moments to inform 
them of the information they missed. 
 
5. Substance Free Activity Session Review (5 minutes) 
a. Last time, we talked more about the hobbies/activities you would like to try. What 
steps were you able to take towards starting the activities you mentioned?   
i. Allow the participant time to reflect and discuss the resource guide from 
the last session .  
b. Since _____ is a really important activity to you, what are some things that you 
can do to make progress towards this goal?  
i. Possible questions you might ask: 
1. What would be the benefits of achieving these goals?  
2. What do you think might get in the way?  
3. How will you know if your plan is working?  
4. How will you know if you are getting off track? What steps would 
you take to get back on track?  
c. Summarize the goals/plans to the participant has for implementing substance-
free activities.  
i. So you still want to try ______, but it turns out it costs too much to join the 
gym. So instead, you’re thinking about ____. Does that sound right? 
 
6. Mindfulness-Based Adherence Promotion Intervention (20 minutes) 
a. Orientation 
i. Let’s spend a few minutes today talking specifically about the SOBER 
acronym. 
1. S is for Stop and see what happens 

 
76 
2. O is for Observe physical sensations and emotion regelation 
changes in the body 
3. B is for Breathe by deliberately bringing attention to the breath  
4. E is for Expand your awareness of the situation 
5. R is for Respond mindfully 
6. These last two letters are very important to practice but can 
sometimes be a little more challenging to understand. Let’s talk 
about it.  
b. Surf the Urge 
i. Sometimes in the moment urges or moods can feel overwhelming – does 
that sound familiar? Our natural tendency is to give in to momentary 
urges and maybe in the past we have used alcohol or drugs to cope with 
urges, but we do have a choice. We can learn to “surf the urge” of a 
trigger to ride out cravings, urges, and triggers as they come up.  
ii. Let’s practice this now. 
iii. I want you to imagine a situation that you are currently dealing with, 
maybe something recent that you found triggering. This doesn’t need to 
be the most difficult situation you can think of, but one that is difficult or 
challenging for you. 
1. For those who are currently distressed, no need to elicit a trigger 
iv. Do you have something in mind? 
v. OK, let’s walk through the steps. 
1. Stop: Just take a moment to stop your immediate urge to react.  
2. Observe: Take a moment to really assess what you’re feeling. 
Notice your emotions. Also, notice how your body feels during this 
time.  
a. Also notice any thoughts that are coming up. 
3. Breathe: Take at least three deep and slow breaths to ride the 
wave of your trigger. Allow yourself to focus on the rhythmic 
breathing. You don’t need to change your breathing, just notice it. 
a. Take a minute to breathe with the participant in through 
their nose and out through their mouth slowly.  
b. You might notice your mind wandering. That’s ok, just 
bring it back to the breath. 
4. Expand: Work to expand your awareness of the situation. You 
already are slowing down your breath, now focus on the breath to 
allow your body and your mind to soften. We are expanding our 
awareness back out to the feelings in the body, the sensations of 
being in the room, and allowing ourselves to be centered and 
grounded in this moment. 
5. Respond: Allow yourself to respond mindfully. How can you truly 
take care of yourself in this situation? What do you really need? 
Take a moment to choose your response – knowing that you do 
have a choice.  
a. People may think of this as “wise mind” – acting with 
purpose and reason. 
b. Importantly, the person might still choose the same 
reaction/response – that is okay. Our goal is to just be 
more present with our response to situations, triggers, 
urges. Allow the participant some time to process this part 
of SOBER. Encourage the participant to be empowered to 
make a choice and to be more present when choosing a 
response.  

 
77 
 
7. Wrap-Up (2 minutes) 
a. We covered a lot today during our session. I did want to remind you that next 
time is actually going to be our last session together! Do you have any questions 
for me today?  
b. Let’s schedule our final session together. 
c. Provide participant with date and time of session.  
 
 

 
78 
Psychosocial Intervention Session 4 (38 minutes with assessments):   
1. Introduction (1 minute)  
a. Getting Permission to Record 
b. Hi _____, how are you today? Is this still a good time for us to do our final 
session together? Great! And before we get started today, do I have your 
permission to record this session? Wonderful, thank you!   
 
2. Assessment (20 minutes)  
a. Complete session four assessment forms in FileMaker.  
b. Because you finished your assessment, I will mail you that $25 gift card. Do you 
prefer Kroger or Walmart? Please allow 2-3 business days for it to arrive.  
c. Thanks for getting the assessment completed today. 
 
3. Orientation to Session (1 minute) 
a. Today, we will discuss improving self-control. We’ll also review the opioid-free 
activities you’ve been trying, and touch base on how SOBER has been working 
for you.  
b. What questions or thoughts do you have for me before we get started?  
c. If the participant missed the previous session , take a few moments to inform 
them of the information they missed.  
 
4. Improving Self-Control (5 minutes) 
a. I would like to introduce you to an activity we call “improving self-control.” 
b. You may not know this, but self-control changes for people during the course of 
recovery. 
c. What do you think self-control is? 
i. 
Let participant answer. 
ii. 
Yes! We also think of it in these ways: 
1. The ability to identify your long-term goals and act in a way that is 
consistent with those goals 
2. The ability to wait for a bigger reward to come at a later time. 
3. The ability to keep working on a task or goal even if it difficult or 
results in frustration or set basks 
d. Improving Self-Control 
i. 
What are some ways you think people can improve their self-control? 
1. Great ideas! I have some other ideas – do you mind if I share 
them? 
2. Identify your short and long term goals  
a. What are your values, what is important to you in life? 
b. Where do you want to be in 2 years? In 10 years? 
3. Write down these goals and consult them regularly as you decide 
on what you are going to do each day. 
4. Make your goals public (post them on Facebook, tell your friends 
and family)  
a. GET SOCIAL SUPPORT 
5. Record your progress towards your goals (can do this with pencil 
and paper, on your phone, or on your computer) 

 
79 
6. Make specific commitments to the things you want to get done 
(e.g., if you want work out every morning, make a plan to do this 
with a friend). 
7. Use rewards for accomplishing your goals (stickers, money you 
put away to spend if you accomplish your goal each week, etc.). 
8. Remind yourself of the benefits of accomplishing your long term 
goals (e.g., a promotion, higher salary, nurturing important 
relationships, being healthy, etc.) 
9. Self-control is like a muscle. Self-control gets stronger with 
practice – its gets easier over time to resist temptation and to stick 
with your healthy routines and commitments.  
a. Also remember HALT: hungry, angry, lonely, tired. It’s hard 
to have self-control if you are tired, grumpy, hungry, sad, 
etc. Get good rest, eat well, exercise, take short breaks 
from challenging activities, and plan fun events to keep 
your mood good. 
10. Identify (and avoid) high risk people and situations that get in the 
way of your goals 
11. What do you think about these ideas? Would you find any of them 
useful? Which ones? 
 
5. Substance Free Activity Check In (5 minutes) 
a. I know we’ve talked a lot about some activities/hobbies you’ve started to work on. 
How has it been going trying _____? 
i. 
Allow the participant a few minutes to discuss the opioid-free activities.  
b. Focus the conversation on problem-solving any barriers that have come up for 
them with their new activity/hobby.  
c. I have one more tip to offer you as you continue to fill your time with new opioid 
free activities. It’s always helpful to have a calendar or use your phone to 
schedule your plans. This will be helpful to increase your awareness of what’s on 
your schedule and the activities you have to look forward to! 
d. What other questions do you have about your new opioid-free activities? 
 
6. Mindfulness-Based Adherence Promotion Check In (5 minutes) 
a. Tell me a little bit about your experiences in using the SOBER breathing space.  
b. Take some time to complete one final review of SOBER and problem-solve ways 
to help the participant use this in daily life.  
c. SOBER stands for:  
i. 
Stop and see what happens 
ii. 
Observe physical sensations and emotion regulation changes in the 
body 
iii. 
Breathe by deliberately bringing attention to the breath  
iv. 
Expand awareness of the situation  
v. 
Respond mindfully (versus reacting) 
d. We’ve gone over how to use the SOBER breathing space when experiencing 
cravings, urges, and triggers. How do you think you will continue to use this skill 
to support your recovery?  
 
7. Wrap-Up (1 minute) 
a. We have covered a lot of things during our sessions together over the past few 
months. What questions do you have for me?  

 
80 
b. Allow the participant to process any last-minute concerns or questions. Thank the 
participant for their time in the study.  
 
 
 
*Participants will also receive a copy of the “Tips for Improving Self Control Handout” located on 
OneDrive.* 
 

 
81 
14. VIRTUAL MAILING PROCEDURES  
Session /Mailing Procedures:  
Baseline  
• 
If participant completes the full package in-person, they will receive a $50 gift card before they 
leave the clinic.  
 
o Each interventionist is responsible for taking care of their own gift cards and welcome 
package (T-shirt, copy of consent, SOBER handout [BSM group only], and business 
card).  
 
Instructions:  
§ 
Log gift cards out of the safe.  
§ 
Complete the GC sheet and make copy of gift card for study records.  
• 
Ppt. will need to sign off on the sheet. Once completed place in GC 
binder. 
§ 
Present GC to ppt  
§ 
Welcome ppt. to the study and hand them their welcome bag.  
§ 
Schedule next session (based on their appt. with clinic).   
 
 
• 
If the participant takes the packet home, they will need to return the package back or call to 
complete the assessment over the phone. Once completed, we will mail them a $50 gift card; if 
they come back into the clinic, we will give them a gift card in person.  
 
o Each interventionist is responsible for taking care of their own gift cards and welcome 
package (T-shirt, copy of consent, SOBER handout [BSM group only], and business 
card).  
 
Instructions:  
§ 
Schedule a time to complete baseline.  
• 
Inform the ppt. that we will not be able to mail GC without 
completing the pack first.  
§ 
Welcome ppt. to the study and hand them their welcome bag.  
• 
T-shirt, copy of consent, SOBER handout [BSM group only], and 
contact card.  
• 
No GC will be given until pack is completed.  
Once baseline is completed:  
§ 
Log gift cards out of the safe.  
§ 
Complete the GC sheet and make copy of gift card for study records.  
• 
Once completed place sheet in GC binder (ppt. will not need to sign).  
§ 
Mail GC to ppt.  

 
82 
• 
Mail can be dropped off at the UCH lobby or nearest postal office.  
• 
Use SMART mailer and envelop. 
 
 Sessions 1-3 (Virtual)  
• 
After the participant completes all the assessments and the intervention, they will receive their 
GC. Appointments will be scheduled within 30 day windows.  
 
o CM Group Instructions:  
§ 
Complete assessments  
§ 
Inform ppt. of the GC amount they will receive, and to please allow 2-3 
business days to arrive.  
• 
$50 for completing assessments.  
• 
Additional GC will depend on the following:  
Urine toxicology results 
§ 
If participant is compliant, buprenorphine in their urine, we will 
spin the virtual wheel for them and inform them of the amount 
received.  
§ 
If participant is not compliant, no buprenorphine in their urine, 
we will inform them that they will not be able to participate in 
the number wheel at this time.  
 
§ Study team will take a screenshot of the number wheel and will text or email 
ppt. the results; only when applicable.  
 
§ 
Place ppt. ID and GC amounts in the GC google sheet for future mailing.  
• 
Study staff that is present in the clinic will be responsible for GC 
mailings for that day.  
• 
If no staff is available that day, please inform the ppt. that they will 
receive GC in X number of days (based on when staff will be in clinic 
next). 
§ 
Mail GC to ppt.  
• 
Mail can be dropped off at the UCH lobby or nearest postal office.  
• 
Use SMART mailer and envelop. 
 
 
o BSM Group Instructions:   
§ 
Complete assessments and intervention.  
§ 
Inform ppt. of the GC amount they will receive ($50), and to please allow 2-3    
     business days to arrive.  
§ 
Place ppt. ID and GC amounts in the GC google sheet for future mailing.  

 
83 
• 
Study staff that is present in the clinic will be responsible for GC 
mailings for that day.  
• 
If no staff is available that day, please inform the ppt. that they will 
receive GC in X number of days (based on when staff will be in clinic 
next).  
§ 
Mail GC to ppt.  
• 
Mail can be dropped off at the UCH lobby or nearest postal office.  
• 
Use SMART mailer and envelop. 
 
Note: If study team does not have access to postage stamps, Wednesdays and Fridays will be 
designed gift card mailing days. Study team will alternate days that they deliver gift cards to the 
UTHSC main campus.   
o Wednesdays: Red bag will be dropped off at the Pauline bldg.  
o Fridays: Study team will take the red bag to the mail room in the Madison bldg.  
 
Instructions: 
• 
Use the GC google sheet to confirm gift cards that need to be mailed.  
• 
Log gift cards out of the safe.  
• 
Complete the GC sheet and make copy of gift card for study records.  
• 
Once completed place sheet in GC binder (ppt. will not need to sign).  
• 
Place GC in red bag and take to designed mailing area for that day.  
o Use SMART mailer and envelop.  
• 
Log mileage from clinic to the main office and submit monthly.  
 
Session 4 (Virtual):  Part 1  
• 
After the participant completes Part 1 of the assessments and the intervention, they will schedule 
Part 2 of the session .  
 
Instructions:  
§ 
Complete Part 1 assessments  
§ 
Complete the intervention  
§ 
Schedule follow-up call with the RA. 
• 
RA will be responsible for logging ppt. ID, completion date, and GC amount 
in the google sheet and notifying team of completion status.  
• 
Note: Ppt. will not receive GC unless they complete all parts of the session 
(Part 1 & 2 Assessments and intervention).  
 
 Session 4 (Virtual): Part 2  
To be completed by RA.  
• 
Complete Part 2 assessments and log session info. in the google sheet for future GC mailing.  

 
84 
 
 
Instructions: 
§ 
Complete Part 2 assessments  
§ 
Complete treatment satisfaction survey  
§ 
Notify team of completion (via email or GroupMe msg.).  
§ 
Log study ID, date of completion, and GC amount in the google sheet  
§ 
Mailing will be the same as  Sessions 1-3.  

 
85 
Appendix A. IRB Approval Letter 
 
 
 

 
86 
 
 
 

 
87 
Appendix B. Withdrawal Letter  
  
DATE:  
  
Dear Study Participant:  
This is to notify you that as you requested, you have officially withdrawn from the study “Testing the 
Effects of Contingency Management and Behavioral Economics on Buprenorphine-Naloxone Treatment 
Adherence Using a Sequential Multiple Assignment Randomized Trial” (SMART) Design Internal Review 
Board Number: 20-07418-XP UM. Please be aware that all data you have provided for this study has 
been destroyed and is not accessible by anyone.   
Please contact the study team if you should have any questions regarding your participation in this study 
in the future.  
  
Sincerely,  
Sarah Hand, MPH, CCRP  
Senior Research Project Coordinator  
Center for Population Sciences   
Department of Preventive Medicine   
University of Tennessee Health Science Center   
66 North Pauline, Suite 466  
Memphis, TN 38163  
(901) 448-3174