Clinical trial NCT02995915
Conditions: Smoking Cessation Alcohol Drinking
Sponsor: Duke University
Start date: 2016-11-01; Completion date: 2020-03-02
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Alcohol misuse and smoking constitute two of the three leading preventable causes of death in the United States. The purpose of this research study is to develop an intervention designed to help people stop drinking alcohol and stop smoking at the same time.

Detailed description:
Alcohol misuse and smoking constitute two of the three leading preventable causes of death in the United States. Reluctance to treat tobacco dependence among those with AUD is misguided as recent research suggests smoking cessation treatment can be effective, does not increase risk of relapse to alcohol, and may even improve rates of sobriety. There is strong evidence for the short-term efficacy for alcohol misuse and smoking of contingency management (CM). It is an intensive behavioral therapy that provides incentives (vouchers, money) to individuals misusing substances contingent upon objective evidence from drug use. Implementation of CM has been limited because of the need to verify abstinence multiple times daily using clinic based monitoring. The investigators recently developed a smart-phone application which allows a patient to video themselves several times daily while using a small CO monitor and to transmit the data to a secure server which has made the use of CM for outpatient smoking cessation portable and feasible. This mobile CM (mCM) approach paired with cognitive-behavioral counseling and pharmacological smoking cessation aids has been effective in reducing smoking.

Thus, the purpose of this project is to develop a combined alcohol and smoking mCM intervention. The intervention will be developed in two successive cohorts of five participants, who will provide information on treatment acceptability and feasibility. A third cohort of participants (n=45) will participate in a randomized clinical trials to further examine feasibility and efficacy. The long term goal is to develop mCM procedures that will be used as part of a multi-component intervention to concurrently and effectively treat both alcohol misuse and smoking. As part of this project, the investigators will develop a multi-component telehealth alcohol and smoking mCM intervention. It will include mCM, cognitive-behavioral phone counseling, and standard smoking cessation pharmacotherapy. The work proposed in these aims will provide the first step toward implementation of an innovative approach that builds upon the power of mHealth technology to reduce the prevalence of both alcohol misuse and smoking.

Arms: arm 1: This arm includes a proactive tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, a tele-medicine clinic for access to smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM). arm 2: This arm includes a proactive tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and tele-medicine clinic for access to smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants will receive monetary compensation for each assessment, regardless of abstinence.
Interventions: intervention 1: Nicotine Replacement Therapy intervention 2: Bupropion intervention 3: Cognitive Behavioral Treatment intervention 4: Mobile Contingency Management intervention 5: Mobile Monitoring
Intervention descriptions: intervention 1: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or nicotine lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings intervention 2: All participants who are medically eligible will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up. intervention 3: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation. intervention 4: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence. intervention 5: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.

Protocol documents:
Prot_SAP_000.pdf: 
Mobile Contingency Management for Concurrent Abstinence From Alcohol 
and Smoking 
NCT02995915 
 
 
 
Study Protocol and Statistical Analysis Plan 
Document Date: March 18, 2019 


Research Summary, version date 3/18/2019 
 
Page 1 of 32 
Title: Mobile Contingency Management for Concurrent Abstinence from Alcohol and 
Smoking 
 
Principal Investigator: Eric Dedert, Ph.D. 
 
Background:  
 
Alcohol and nicotine are the most frequently used drugs in the United States (Kandel, 
Chen, Warner, Kessler, & Grant, 1997) and each results in substantial morbidity, 
mortality, and functional impairment. While the rate of smoking is only 19% in the 
general U.S. population, an estimated 60% of those with an alcohol use disorder (AUD) 
smoke (Falk, Yi, & Hiller‐Sturmhofel, 2006). Similarly, daily smokers have approximately 
three to four times the risk of alcohol misuse, while former smokers have risk levels 
near that of those who had never smoked (Chiolero, Wietlisbach, Ruffieux, Paccaud, & 
Cornuz, 2006; Grant, Hasin, Chou, Stinson, & Dawson, 2004; McKee, Falba, O'Malley, 
Sindelar, & O'Connor, 2007). Naturalistic studies of persons who both smoke and 
consume alcohol suggest that smoking and consumption of alcohol tend to occur on the 
same occasions (Gulliver et al., 1995; Lisha, Carmody, Humfleet, & Delucchi, 2014). In 
addition, the pattern of relapse risk across time is similar for smoking and alcohol, 
following a log‐logistic function in which the first days carry the highest risk followed by 
decelerated risk with increased time of abstinence (Kirshenbaum, Johnson, Schwarz, & 
Jackson, 2009). Several studies have observed substantial decrease in alcohol 
consumption in former smokers (Chiolero et al., 2006; McKee et al., 2007; Morabia, 
Curtin, & Bernstein, 1999), and treatment research has found successful smoking 
cessation to be related to subsequent decreases in alcohol consumption (Friend & 
Pagano, 2005). Despite the lethality of these problems and the potential for synergistic 
effects of addressing both AUD and smoking, there is a lack of validated treatment 
approaches for achieving concurrent abstinence (Holt, Litt, & Cooney, 2012).  
 
As chronic, relapsing conditions, AUD and smoking are well‐suited to intensive 
behavioral treatments that intervene frequently in the early stages of achieving 
abstinence (McFall et al., 2010; Willenbring, 2013). Unfortunately, inpatient substance 
use disorder treatment is very costly, and episodic outpatient treatment is often 
insufficient for achieving abstinence (Willenbring, 2013). One especially efficacious 
treatment for AUD is contingency management (CM), an intensive behavioral treatment 
that frequently provides monetary reinforcement of abstinence from substances. 
Among psychosocial treatments for substance use disorders generally, CM has the 
largest effect of any single intervention, but an even larger effect has been observed in 
the few studies that have combined CM with CBT (Dutra et al., 2008). Unfortunately, the 
burdensome requirement of clinic based assessment multiple times each day has largely 
limited the widespread use of CM. 
 
While there is a large body of evidence to support the short‐term efficacy of CM 
approaches for treatment of both AUD and smoking independently, the proposed pilot 


Research Summary, version date 3/18/2019 
 
Page 2 of 32 
intervention will be the first to utilize CM as part of a concurrent treatment of AUD and 
smoking. Because successful smoking cessation alone is expected to reduce relapse to 
alcohol, the advantages of concurrent treatment go beyond the notable benefit of also 
promoting smoking cessation.  Recent efforts have attempted to expand the reach of 
intensive CM approaches through internet based paradigms (Dallery & Raiff, 2011) 
which overcome the need for clinic monitoring and have been found to be helpful in 
reducing smoking among difficult‐to‐treat populations (e.g. adolescents and rural 
populations; (Dallery, Meredith, & Glenn, 2008; Reynolds, Dallery, Shroff, Patak, & 
Leraas, 2008). Building upon web‐based paradigms (Dallery & Raiff, 2011), we have 
developed a smart‐phone based application and website that significantly reduce the 
labor intensity of CM and increase portability even beyond web‐based approaches. The 
innovative use of mHealth technology removes several barriers to the widespread 
implementation of CM approaches including the need to travel to verify abstinence and 
the automation of complex reinforcement strategies. In addition to the application of 
innovative mHealth technology and concurrent treatment of both AUD and tobacco use, 
the proposed research is particularly novel, in our opinion, because it will be the first 
evaluation of smart phone based mobile CM in conjunction with evidence‐based CBT for 
AUD and smoking cessation, which is expected to significantly increase relapse 
prevention.  
 
Despite established short‐term efficacy, CM has not been widely adopted to treat either 
AUD or smoking. One prominent concern is the long‐term impact of CM after 
contingencies are removed. However, follow‐up abstinence rates for CM treatments 
have been improved by the integration of CBT into CM (Carpenter et al., 2014; R. M. 
Kadden, Litt, Kabela‐Cormier, & Petry, 2007). CM‐induced abstinence could provide 
advantages to CBT alone, as it gives the individual a positive early experience with 
abstinence that 1) increases self‐efficacy, 2) increases engagement in CBT, 3) provides 
the opportunity to practice CBT skills in time to acquire and utilize the coping skills 
provided by CBT, and 4) provides time for people to develop alternative reinforcers to 
substance use, and 5) engages people in CBT intervention that includes coping skills 
acquisition and home practice that encourages generalization of skills to the naturalistic 
environment, which likely contributes to the durability of CBT effects on substance use 
outcomes (Carroll et al., 2000; Carroll et al., 1994; O'Malley et al., 1996). There is 
evidence that CM can be used to treat comorbid substance use disorders, as a trial 
targeting only cocaine use in those who used both cocaine and opioids produced large 
and unexpected reductions in opioid use (Silverman et al., 1998). In addition, previous 
research has found that using CM can be effective in increasing simultaneous abstinence 
from multiple substances (Piotrowski et al., 1999).  
 
There is a surprising lack of research aimed at evaluating multi‐component interventions 
that integrate CM with evidence‐based CBT and pharmacotherapy. The addition of CBT 
is critical because CM interventions alone have been limited in their ability to maintain 
behavior change after the removal of the contingency (Dallery & Raiff, 2012). With the 
inclusion of evidence‐based CBT and a tele‐health clinic for NRT, we will be able to 


Research Summary, version date 3/18/2019 
 
Page 3 of 32 
evaluate whether the tele‐health mCM intervention keeps participants engaged in 
treatment, improves NRT adherence, reduces delay discounting (i.e., decreased 
subjective valuing of rewards that are temporally distant), and increases self‐efficacy, all 
of which have been predictive of long term abstinence from both alcohol and tobacco.  
 
Objectives: 
 
The purpose of this pilot project is to gather feasibility data to support grant 
development for a combined alcohol and smoking tele‐health mCM intervention that 
will effectively treat both disorders. The study will be undertaken with the following 
objectives: 
 
1) Develop a multi‐component alcohol and smoking tele‐health mCM intervention 
in two successive cohorts of five participants. The first cohort of treatment 
completers (n = 5) will provide qualitative data from participants and therapists, 
which will be utilized to modify the treatment components including the 
therapist manual, mCM apps, and data collection procedures. The second cohort 
(n = 5) will yield qualitative and quantitative data to refine the intervention and 
in preparation for a pilot trial. 
2) Evaluate the feasibility and acceptability (e.g., mCM app reliability, mCM app 
procedures completion, patient satisfaction) of a tele‐health mCM intervention; 
relative to a comparison group receiving a tele‐health intervention without 
mCM, This will be evaluated in a third cohort that will include a pilot trial 
randomizing participants to telehealth with mCM (n = 30) or to a comparison 
group receiving the same phone counseling (Cognitive Behavioral Therapy; CBT) 
and tele‐medicine without mCM (n = 15). 
 
Methods: 
 
Study Design 
 
A successive cohort design will be used to refine the intervention, resulting in three 
cohorts of participants with AUD and cigarette use. The first two cohorts will focus on 
treatment refinement, followed by a third cohort participating in a pilot trial. 
 
Successive Cohort Design Stage 1: Feasibility 
 
The successive cohort design (SCD; Epstein et al., 2007) is an iterative process designed 
to systematically refine and modify behavioral treatments in the early stage of 
development. The SCD model is a good fit for Stage 1 research, which is designed to 
generate or modify existing protocols and conduct preliminary testing before initiating 
larger efficacy trials (Stage II) and effectiveness research (Stage III).  
 


Research Summary, version date 3/18/2019 
 
Page 4 of 32 
The first cohort of five participants will complete the tele‐health mCM intervention and 
provide evaluative feedback during an in‐depth interview administered at the end of the 
study, and described in the Measures section below. A coding scheme will be developed 
for categorizing comments made during the interview based on the study components 
(e.g., mCM procedures, CBT, interface with smart phone app), subcomponents (e.g., 
mCM feasibility, CBT burden), and the evaluations drawn (e.g., CBT session too long, 
video upload still unclear after mCM training).  
 
Successive Cohort Design Stage 2: Treatment Refinement 
 
After the intervention and study have been modified based on information learned from 
the first cohort, we will treat a second cohort (n = 5). Though qualitative data will be 
evaluated and utilized using methods similar to those of the first cohort, the second 
cohort will more closely evaluate quantitative data. We will explore relationships of 
sociodemographic, baseline substance use, and psychiatric comorbidity variables with 
treatment retention and outcomes. This will identify treatment components to modify 
or enhance to maximize treatment effectiveness.  
 
Successive Cohort Design Stage 3: Pilot Trial 
 
After treatment modifications from cohort 2, we will conduct a pilot randomized 
controlled clinical trial. The primary goal of the trial is to evaluate the efficacy of a 
combined tele‐health mCM intervention. The pilot trial will use a two‐group design in 
which 45 participants with an AUD who smoke regularly will be randomized to either: 
TELE‐HEALTH MOBILE CONTINGENCY MANAGEMENT (mCM) INTERVENTION, a 
proactive tele‐health intervention that combines evidence‐based telephone CBT for 
alcohol and smoking cessation, a tele‐medicine clinic for access to nicotine 
replacement therapy (NRT), and intensive CM therapy administered via a smart‐
phone based application (CM). 
OR 
TELE‐HEALTH FOR ALCOHOL AND SMOKING CESSATION, a proactive tele‐health 
intervention that will provide controls for therapist, medication, time and attention 
effects. The tele‐health intervention provides the same evidence‐based telephone 
CBT for alcohol and smoking cessation, and tele‐medicine clinic for access to 
smoking cessation pharmacotherapy as in the mCM intervention, but does not 
include mCM. Instead, participants will receive monetary compensation for each 
assessment, regardless of abstinence ($3.00 for breathalyzer, $1.00 for CO). No 
escalating or reset contingencies will be used to alter monetary compensation 
amounts in this group. Mobile assessments of abstinence will occur on the same 
schedule as the tele‐health mCM condition. 
 
C.9.2. Participant Recruitment, Eligibility, and Screening  
A total of 55 participants with AUD and smoking will be enrolled across the three 
cohorts. Participants will be recruited from primary care and substance abuse clinics at 


Research Summary, version date 3/18/2019 
 
Page 5 of 32 
Duke University. We will also post flyers at local hospitals and in community settings. To 
allow more detailed analysis of the tele‐health mCM intervention that is the focus of 
this study, the pilot trial conducted with the third cohort will randomize 30 participants 
to the tele‐health mCM intervention, and 15 to the tele‐health smoking cessation 
comparison condition. 
 
Completers of the proposed tele‐health mCM intervention will provide self‐report data 
and evaluative feedback during an in‐depth interview administered at the end of 
treatment, and described in the Assessments section below. Content analysis of the 
resulting data will evaluate study components (i.e., mCM procedures, CBT, interface 
with smart phone app, NRT utility and adherence) and subcomponents (e.g., mCM 
feasibility, CBT burden) that they address and the evaluations drawn (e.g., CBT session 
too long, video upload still unclear after mCM training). We will explore 
sociodemographic, substance use, and psychiatric comorbidity variables to examine the 
magnitudes of their associations with treatment retention and outcomes. This will 
identify areas of the treatment potentially in need of modification or enhancement to 
maximize its effectiveness. A summary of the findings will be evaluated by our team of 
clinical researchers (Drs. Dedert, Beckham, Calhoun), all of whom are experienced in 
treatment development and trial design, will evaluate a summary of the findings and 
determine changes to make to the intervention. 
 
Recruitment 
 
Participants will be adult men and women with mild to moderate AUD who smoke 
cigarettes. We aim to enroll 55 participants in the study. In order to reach this 
enrollment goal, we anticipate that 70 participants will sign consent forms. Participants 
will be recruited from primary care and substance use clinics at Duke University Medical 
Center (DUMC). Flyers and brochures will be placed in DUMC clinic areas, and may also 
be placed in community settings such as local restaurants and grocery stores. We will 
also advertise in local newspapers and online classified services such as 
www.craisglist.com and www.dukelist.duke.edu. We will also utilize Duke IRB‐approved 
recruitment services such as ResearchMatch and the Duke Clinical Research Unit 
Research Volunteer Registry to invite patients who have indicated interest in research to 
participate in this study. Finally, Duke providers who would like to invite potentially 
eligible patients to participate in this study will send an invitational letter with a basic 
study description and contact information for study staff. This letter asks patients to let 
the provider know if they do not wish to be contacted about the study. For the 
remaining patients, after waiting at least 10 days, the provider will deliver contact 
information by secure Duke email to study staff. Study staff will then contact patients to 
discuss the study and invite the patient to screen if the patient is potentially eligible. An 
example of the type of letter providers will send is included for IRB review. However, 
please note that providers will be free to write their own letters or modify this letter 
according to their clinical judgment of the type of information that will be most useful 
for informing their patients.  


Research Summary, version date 3/18/2019 
 
Page 6 of 32 
 
Our study team will use social media to reach potentially eligible participants. We have 
developed a Facebook page for posting IRB‐approved study flyers and information for 
this and other studies in the Traumatic Stress and Health Research Laboratory, 
https://www.facebook.com/Duke‐Traumatic‐Stress‐and‐Health‐Research‐Lab‐
379366159145563/. We plan to place pictures of our study flyers on the Facebook page, 
and use Facebook’s post boost to draw attention to the post. The post itself will say 
“Enroll now!” or “Now enrolling!” We will also plan to use Facebook ads to target 
potential participants within a 50‐mile radius of Duke. The proposed Facebook ad 
photos and text have been uploaded to the recruitment materials section of the eIRB 
space. If any participant contacts the email associated with the Facebook page 
(TSHRLab@dm.duke.edu, he/she will be sent an automatic email response. Potential 
participants will also be allowed to indicate that they would like to be contacted by the 
study coordinator by completing a "Contact Me" RedCap survey that gathers their name 
and contact information.. We have attached a screenshot of the RedCap survey with this 
IRB submission, and here is the link to the RedCap Survey: 
https://redcap.duke.edu/redcap/surveys/?s=DCAJXYDCEY. Any participant who 
completes the RedCap survey will be contacted by the study coordinator using the IRB‐
approved telephone script. 
 
If any potential participant contacts the PI or study coordinator by email via 
clinicaltrials.gov, we will send him/her a secured email response asking that he/she 
contact the study coordinator by phone. Any participant who contacts by telephone the 
study coordinator or other study staff regarding the study will be provided more 
information, and will be interviewed using an IRB‐approved telephone screening.  
 
Participants eligible at the phone screen will be scheduled for a screening visit. An email 
address will be collected from the participant to send directions and a parking pass for 
the screening location and send reminders of upcoming study appointments. If a 
participant does not have access to email or a printer, study staff will collect a mailing 
address to send directions and a parking pass via FedEx or traditional mail. Some of our 
participants strongly prefer email communication re: appointments, so we will plan to 
use secured emails re: appointments, etc. for those participants who prefer it.   
 
Three study visits (screening visit, end‐of‐treatment, and six‐month follow‐up) will occur 
at Duke‐leased space at Hock Plaza, and the others will occur via telephone. Once a 
participant reports to the laboratory to begin the study, the study staff member 
obtaining consent will explain the study in detail, provide the participant with an IRB‐
approved written consent form explaining the procedures and risks, and answer any 
questions. The initial consent process and documentation takes place in a quiet, private 
office at Hock Plaza, and participants are given the chance to thoroughly read the 
consent prior to participation. Participants are given a copy of the signed informed 
consent form, and are given phone numbers to call if they have additional questions 
about the consent form or the research, if they have any problems during the study, or 


Research Summary, version date 3/18/2019 
 
Page 7 of 32 
if they have questions about participating in research studies in general. No study 
procedures will begin until informed consent has been obtained. 
 
Participants 
 
Participants will be eligible for inclusion in the study if they meet the following criteria:  
 currently meet criteria for DSM‐5 alcohol use disorder (meeting 2‐8 criteria for 
AUD) 
 have been engaging in hazardous drinking over the past month, defined as either 
exceeding a mean of 14 standard drinks/wk for men, 7 drinks/wk for women; or 
by consuming >5 on at least one occasion in the last month for men, >4 drinks on 
at least one occasion in the last month for women 
 currently smoke at least 7 cigarettes per week 
 can speak and write fluent conversational English 
 are between 18‐80 years of age 
 are willing to make an attempt to quit both alcohol and smoking  
 
Participants will be excluded from the study for the following:  
 are expected to have unstable medication regimen during the study 
 are currently receiving non‐study behavioral treatment for alcohol use disorder 
or smoking 
 have alcohol use disorder that exceeds our severity threshold of 8 symptoms or 
exhibit significant risk for alcohol withdrawal. 
 have AUD that is in early remission, with no symptoms evident over the past 
month 
 have experienced myocardial infarction in past 6 months 
 contraindication to nicotine replacement therapy with no medical clearance to 
participate in the study 
 use other forms of nicotine such as cigars, pipes, or chewing tobacco 
 are currently pregnant 
 have a primary psychotic disorder or current manic episode 
 have had substance use disorder (other than alcohol or nicotine) in the 
preceding 3 months 
 are currently imprisoned or in psychiatric hospitalization 
 
Table 1. Study Procedures 
 
Session 
# 
Location of Visit 
Procedures 
Payment 
1 
Lab 
Consent; psychiatric interview; 
questionnaires; urine drug screen 
and pregnancy test; carbon 
monoxide and breath alcohol 
readings 
$50  


Research Summary, version date 3/18/2019 
 
Page 8 of 32 
1‐3 weeks 
2 
Phone 
Counseling session 1 of 4 
n/a 
1 week 
3 
Phone 
Counseling session 2 of 4; begin 
practice mCM monitoring, begin 
bupropion if eligible 
Up to $34 for 
monitoring 
1 week 
4 
Phone 
QUIT DATE; counseling session 3 of 
4; begin active mCM monitoring OR 
active mobile monitoring (MM); 
begin nicotine replacement therapy 
(NRT) 
n/a 
2 weeks 
5 
Phone 
Counseling session 4 of 4; continue 
active mCM monitoring OR active 
mobile monitoring 
n/a 
1 week 
6 
Phone 
Final week of abstinence induction 
in mCM group; MM group continues 
monitoring; questionnaires 
Up to $702 (mCM) 
OR $132 (MM) for 
active monitoring;  
$50 for assessment 
2 weeks 
7 
Lab 
End thinning (mCM group) OR 
mobile monitoring (MM group); 
return equipment; questionnaires; 
end NRT and bupropion; saliva 
sample; interview about treatment 
Up to $400 (mCM) 
OR $88 (MM) for 
continuing 
monitoring 
$35 for equipment 
return; $50 for 
assessment; $50 for 
saliva sample 
6 months after Session 4 
8 
Lab 
Questionnaires; saliva sample; blood 
spot collection 
$50 for assessment 
and $50 for saliva 
sample; $50 for 
blood spot test 
TOTAL COMPENSATION 
POSSIBLE:   
mCM Group 
Mobile Monitoring 
 
$1521* 
$639* 
*because compensation depends partly on the number of alcohol breathalyzer prompts, 
it is possible that the total compensation will vary slightly. 
 


Research Summary, version date 3/18/2019 
 
Page 9 of 32 
Consent and Screening Procedures 
 
Prior to study entry, potential participants will complete a screening visit, including 
informed consent, the diagnostic interview, breath samples to assess alcohol and CO 
level, symptom self‐report measures, alcohol and smoking history, mental health 
treatment history, and sociodemographic data. Participants will complete the 
Structured Clinical Interview for DSM‐IV (First, Spitzer, Gibbon, & Williams, 1994) to 
diagnose AUD and psychiatric comorbidities. Urine samples will be obtained to screen 
for illicit drug use. Because urine drug screen results are not exclusionary, but rather 
provide descriptive information about the study population, any participant may refuse 
to provide a urine sample for drug screen purposes. We have not added this caveat to 
the informed consent form because we want to encourage participants to provide the 
urine samples. At any time, if a participant refuses to provide a urine sample, this will be 
documented as a protocol deviation. Of note, to date we have had no participants in 
studies in the Traumatic Stress and Health Research Laboratory refuse to provide a urine 
sample for drug screening. Urine drug screen results are collected on the participants’ 
screening cover sheet in their research folder, and then are entered into a password 
protected database that is stored on the Duke psychiatry protected server; this 
database contains only deidentified data. Because the study drugs are each Category C 
drugs, urine pregnancy tests will also be completed for women of childbearing potential. 
We have developed a short interview for female participants; this interview will help us 
determine which female participants must have a urine pregnancy test, and when the 
test should be done. Female participants of childbearing potential who are not pregnant 
must agree to use appropriate contraception during the course of the study, and to 
notify study staff if they become pregnant during the study. Breath alcohol level (BrAC) 
will be assessed and must be 0.0 to continue with the screening.  
 
Participants will be screened for good health via self‐report. If any participant indicates 
that he/she has a primary care provider and/or other treating physician, and the 
participant endorses contraindications to medications our study physician plans to 
prescribe for smoking cessation, medical clearance to take those medications will be 
obtained from that care provider (see letter to physician). If the request is denied, 
potential participants will be excluded from taking any contraindicated medications. If 
the request is not returned within two weeks, the study physician will determine 
eligibility for study medications. We are seeking medical clearance rather than excluding 
participants from taking smoking cessation medications to ensure that we are not 
prematurely ruling out participants who may benefit from smoking cessation 
pharmacotherapy. We are consulting with their primary physician to determine if the 
use of nicotine replacement therapy is appropriate and safe given their current physical 
status and medication regimen. All participants who are medically eligible will also be 
prescribed bupropion. If a participant with a seizure disorder, history of or current 
hepatitis and/or cirrhosis, renal impairment, and/or uncontrolled diabetes wishes to 
enroll in the study, he/she will not receive contraindicated medications. Participants are 


Research Summary, version date 3/18/2019 
 
Page 10 of 32 
informed that they are not required to take bupropion, and will be allowed to 
participate in the study if they refuse to do so.  
 
Telehealth Mobile Contingency Management (mCM) Intervention  
All enrolled participants will receive a tele‐health intervention that combines evidence‐
based telephone CBT for alcohol and smoking cessation, access to nicotine replacement 
therapy (NRT), and intensive CM therapy administered via a smart‐phone based 
application (mCM). The treatment components are separately described below. After 
the baseline assessments to determine eligibility, participants who screen into the study 
will be given smart phones with the mCM app. Participants will also receive a 
breathalyzer and CO monitor. Participants will receive training on mCM procedures by 
study staff. They will then be asked to start submitting practice alcohol and CO 
monitoring videos the day after the screening to provide more time to become expert at 
the mHealth technology and troubleshoot any problems with the assistance of the study 
staff. 
 
Once any necessary approvals for study medications have been provided by the 
participant’s treating physician, participants will advance to the practice week, in which 
participants will be reinforced for completing readings, not contingent on abstinence. 
The practice monitoring will be followed by 3 weeks of Abstinence Induction mCM in 
which monetary reinforcement is provided for every scheduled video, contingent on 
alcohol and smoking abstinence. This will be followed by two weeks of Thinning mCM in 
which the monetary reinforcement remains contingent on alcohol and smoking 
abstinence, but the reinforcement is provided once weekly for providing videos 
bioverifying alcohol and/or smoking abstinence throughout that week. Participants can 
earn $200 for the week if they bioverify abstinence from both alcohol and cigarette 
smoking throughout the week, and must submit at least 90% of weekly videos. If 
participants bioverify abstinence from only one substance throughout the week, they 
will be reinforced $50. The frequency of monetary reinforcement is being reduced in the 
Thinning mCM phase to assist participants in transitioning from intensive monetary 
reinforcement toward managing triggers with infrequent reinforcement. This is 
designed to prevent relapse and promote long‐term abstinence from alcohol and 
cigarette smoking. Target quit dates will be set for the end of the practice week. 
Participants will provide substance use data throughout the mCM phase by completing 
their readings using the mCM app. They will complete interview and self‐report measure 
outcome assessments at 3 weeks post‐quit date (end of Abstinence Induction), at 5 
weeks post‐quit date (end of Thinning mCM), and at 6‐month follow‐up. 
 
Mobile CM Procedures 
As part of a previous project, we developed a smart phone app that allows CM to be 
used outside the clinic to address substance misuse (screenshot shown in Figure 1). On 
this app, individuals can generate a videorecording of themselves breathing into 2 small 
monitoring devices. The breathalyzer and CO monitor are both hand‐held battery 


Research Summary, version date 3/18/2019 
 
Page 11 of 32 
operated instruments that measure alcohol in g/dL and CO in ppm, providing 
lightemitting diode (LED) readings that are visible from the phone’s video recorder. 
 
The CO breath monitor, the iCO Smokerlyzer, is a battery operated instrument that 
measures CO in ppm (http://www.bedfont.com/shop/smokerlyzer/ico_smokerlyzer). 
The Bedfont/coVita iCO™ Smokerlyzer® plugs into a smart phone by means of the 
headphone jack, and communicates with the smart phone app developed by our team. 
Participants are able to see the CO reading within the app, and the app collects the CO 
data directly. Data are stored in the same manner as the video recordings that 
participants upload (see below and in “Protection From Risks: Data Security” herein). 
 
With regards to FDA device issues, Bedfont/coVita will not be seeking 510k Clearance on 
the iCO™ Smokerlyzer® because it does not meet the standard/criteria of a medical 
device. Device manufacturers are required to follow FDA guidance to inform them of 
when a device necessitates 510k application. Per Jason Aversano at Bedfont/coVita, 
their regulatory team has determined that this is not necessary primarily because they 
do not make a medical claim about the device, as it is not designed to diagnose a 
disease or illness. Simply measuring CO is not diagnosing a disease or illness and we 
make no medical claim on the iCO™ Smokerlyer® that it can be used to screen for CO 
poisoning. 
 
For each video recording, participants will be asked to 1) begin a recording using the 
smartphone device; 2) show the pre‐assessment zero breathalyzer reading to the 
camera; 3) expel air from lungs into the breathalyzer while being video‐recorded; 4) 
show the final reading to the camera; and 5) log in to a secure website through the app 
interface on the Google Android operating system that includes pages tailored to each 
participant, and upload the video recordings using encrypted network connections. 
Immediately after completing a breathalyzer reading, participants will provide a CO 
reading following the same procedures. Participants will receive a chart with 
descriptions detailing the rules for earning incentives. Because reinforcers are most 
effective when delivered immediately after the target behavior is performed (Lattal, 
2010), the phone app is designed to allow therapists to provide quick feedback on 
abstinence status, financial amount earned, and how the amount was calculated. 
Participants will be informed that results are pending video review from the study 
coordinator to confirm validity. Based on a previously published protocol using mobile 
CM for alcohol, the alcohol assessments for our study will occur from awakening until 
the participant goes to sleep at night, with a higher probability of assessment occurring 
during high‐risk alcohol consumption times during the day (Alessi & Petry, 2013). High‐
risk consumption times will be based on alcohol consumption patterns, rather than 
smoking patterns, because alcohol is eliminated from body more quickly than CO from 
smoking. The alarm algorithm targets a mean of 10 readings each week, with a variable 
number of alarms across weeks. This will ensure that there are no times in which 
participants are aware that there will be no more assessments for the week. The app is 
designed to alarm‐prompt assessments that could potentially occur at any point during 


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Page 12 of 32 
waking hours, occurring on at least five high‐risk periods each week, and twice in the 
same evening on at least two evenings each week. This procedure is designed to ensure 
that participants do not know when they will have a long period of time between 
readings that would provide an opportunity for drinking alcohol that would be 
metabolized before the next reading. When prompted, participants will have one hour 
to submit their reading, with reminder prompt at 30 minutes. Similar procedures have 
been employed with good adherence and have been well‐tolerated in one published 
study (Alessi & Petry, 2013). Participants will be allowed to opt out of alarms for one 
hour if there are circumstances that would prevent them from safely or conveniently 
responding to an alarm (e.g., while driving, at a meeting, etc.). When participants are 
alarm‐prompted to submit an alcohol reading, they will also receive a text message sent 
to their personal phone number informing them that they have an alcohol reading due 
for submission. The text message will read “A research alarm has gone off. Please 
upload a video by xxxx!” Nothing in the text message to participants will give away the 
nature of this study. This text message is designed to assist participants who are in loud 
areas or will not be near enough to the study‐provided phone to hear the prompt. This 
additional informational procedure is based on qualitative feedback from participants in 
our first two cohorts, who wanted to adhere to monitoring but did not always hear the 
study phone prompts. Participants who prefer not to receive text messages on their 
personal phones will be able to opt out of text messages from the study at any time. 
 
Because CO from smoking a cigarette is metabolized more slowly than a drink of 
alcohol, CO can be assessed less frequently. To take advantage of this feature of CO, and 
to reduce participant burden, we will ask participants to provide CO assessment videos 
at two times each day chosen by the participant, as long as the two CO assessments for 
that day are at least 8 hours apart. By designing the protocol to have CO assessments at 
times chosen by the participant, we expect to relieve participants of the burden to carry 
both the alcohol breathalyzer and the CO monitor during the day. This way, only the 
breathalyzer must be kept with the participant to respond to alarms. For example, 
participants could choose to complete the CO assessments before leaving the house in 
the morning and after returning in the evening. Participants will submit videos as 
needed before the practice week as study staff coordinate approvals for smoking 
cessation pharmacotherapy with the participants’ medical provider. Once the study 
practice week is initiated, participants will be compensated for practicing this data 
collection for one week (see contingency table in mCM manual). Through the smart‐
phone app, participants log‐in to a secure website to upload their video recordings and 
see personalized information regarding their reinforcement information. Study 
coordinators can monitor validity and compliance on a daily basis and offer feedback to 
ongoing participants regarding compensation so they are well‐practiced at the 
procedures by the time contingent reinforcement is initiated. During the practice week, 
participants will be compensated $2.00 for completing a valid alcohol reading, and $1.00 
for a valid smoking reading. After the practice week, the MM group will receive $3 for 
providing a valid on‐time Breathalyzer reading and $1.00 for providing a valid on‐time 
CO reading, regardless of whether they are abstinent from the substance. After the 


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Page 13 of 32 
practice week, monetary reinforcement for the mCM group becomes contingent on 
abstinence, operationally defined as breathalyzer readings that are < 0.02 BrAC and CO 
readings that are < 6 ppm (after the first week). In the first week of abstinence, smoking 
cessation compensation will be based not on CO < 6ppm, but on a proportion of 
participant’s baseline CO as defined by Lamb (Lamb, Morral, Kirby, Iguchi, & Galbicka, 
2004). Because an escalating, versus a fixed reinforcement schedule has produced 
higher abstinence rates (Heil et al., 2008; Stoops et al., 2009), an escalating schedule will 
be used in this protocol. If on each day, if a participant submits all required videos, and 
all videos suggest that they have been abstinent from both alcohol and cigarettes, they 
will receive a $5 bonus (Sunday through Wednesday) or a $10 bonus (Thursday through 
Saturday). Participants will be asked to return the monitoring equipment at the end of 
the monitoring period. To ensure that participants return the breathalyzer, CO monitor, 
and phone, we are providing postage paid return mailers and adding a $35 incentive for 
equipment return. 
 
Cognitive Behavioral Therapy for Alcohol Use Disorder and Smoking Cessation 
Tele‐health mCM treatment will include 4 sessions of CBT telephone counseling for 
alcohol and smoking cessation, outlined for the therapists in the treatment manual. 
Though CBT has not been combined with CM in previous AUD treatment, CBT has been 
used in combination to concurrently treat alcohol use and smoking, and it was feasibly 
implemented and well‐tolerated (Laaksonen, Vuoristo‐Myllys, Koski‐Jannes, & Alho, 
2013). We have developed the CBT manual by drawing on the cognitive‐behavioral 
coping skills therapy portions of the treatment manual generated from Project MATCH 
(NIAAA coping skills manual from Project MATCH, 2003) and the Integrated Care for 
Smoking Cessation manual (McFall et al., 2010), two treatment with empirical evidence 
of efficacy (R. Kadden, Carbonar, Litt, Tonigan, & Zweben, 1998). Due to the substantial 
overlap in treatment procedures and skills acquired in CBT for alcohol and smoking, the 
first 40 minutes of each session will be devoted to material that applies to both 
problems. The final 20 minutes of each session will primarily be devoted to CBT for 
alcohol, as the CBT for alcohol from which our manuals were developed has more total 
treatment time than the manual from which CBT for smoking was adapted. 
 
Pharmacotherapy for Smoking Cessation 
Treatment will include standard pharmacotherapy for smoking cessation. This consists 
of bupropion, nicotine patch, and an 8‐week course of < 2 rescue methods (e.g., 
nicotine gum, lozenge) in participants for whom these medications are not 
contraindicated or who receive medical clearance from a physician. Participants will be 
screened for suitability for NRT or other smoking cessation medication. Participants who 
report being contraindicated to bupropion or NRT (i.e. high blood pressure not 
controlled by medication) must obtain authorization from their physician prior to 
receiving the corresponding medication. If the patient does not have a physician, or the 
physician does not respond to information requests, Dr. Moore will make 
determinations about whether to authorize study medications. Dr. Moore will prescribe 
a tailored amount and delivery type of NRT based on number of cigarettes smoked per 


Research Summary, version date 3/18/2019 
 
Page 14 of 32 
day, quit history, medical conditions, and psychiatric comorbidities. NRT and bupropion 
will be provided via mail. Dr. Moore will write the NRT and/or bupropion prescriptions 
and work with other study staff and participants' primary care physician to discuss 
contraindications. Eligible participants will be provided bupropion for eight weeks. 
Participants will be informed that they can discuss whether or not to continue 
bupropion use for relapse prevention with their personal physician. At the end of the 
study’s course of bupropion, participants will be reminded to confer with their physician 
re: continued bupropion use. For participants who relapse to smoking or are unable to 
quit, Dr. Moore will make decisions about whether to prescribe additional NRT to assist 
the participant in their continued attempts to stop smoking. 
 
6‐Month Follow‐Up 
All participants will be asked to provide a saliva sample to bioverify smoking abstinence. 
Alcohol abstinence will be measured by self‐report, breathalyzer, and a blood spot 
sample that measures PEth at the 6‐month follow‐up. Participants will be encouraged to 
attend the 6‐month follow‐up assessment in the lab. However, if participants are unable 
due to transportation issues or decline to attend the 6‐month follow‐up, we will 
administer interview and questionnaire measures by phone and collect saliva samples 
by mail. 
 
Drinking and smoking will also be monitored by the smart phone app with entries during 
the day for any drinking and smoking occasions. In addition, before the participants’ set 
bedtime, they will be prompted to estimate their total amount of drinking and smoking 
during the day. Finally, at the 6‐month follow‐up, participants will complete a timeline 
follow‐back assessment of alcohol use and smoking, conducted by phone. At the 
screening session, we will administer a questionnaire developed specifically for this 
study that asks about beliefs regarding concurrent treatment of substance use 
disorders. This is called the Concurrent Treatment Questionnaire in Table 2. This will be 
administered at the screening session, end of monitoring, and 6 month follow up. The 
NOSIE, Nicotine and Other Substance Interaction Expectancies Questionnaire, will also 
be administered at these points (Rohsenow, et al. 2005). 
  
Table 2: Study Baseline and Outcome Measures 
 
BL 
CBT 
PT 
EM 
FUP 
BACKGROUND VARIABLES 
Demographics 
X 
 
 
 
 
AUDIT 
X 
 
X 
X 
X 
RAPI 
X 
 
X 
X 
X 
Sheehan Disability Scale 
X 
 
 
 
X 
FTND 
X 
 
X 
X 
X 
SCID 
X 
 
 
 
 
CIWA 
X 
 
 
 
 
QSU 
X 
 
X 
X 
X 
MNWS 
X 
 
 
 
 
Smoking History measure 
X 
 
 
 
 
PANAS 
X 
 
X 
X 
X 


Research Summary, version date 3/18/2019 
 
Page 15 of 32 
AASES 
X 
X 
 
X 
X 
RSEQ 
X 
 
X 
X 
 
ISI 
X 
 
X 
X 
X 
MTSS 
X 
X 
X 
X 
X 
NRT Contraindications 
X 
 
 
 
 
DAR 
X 
 
X 
X 
X 
Patient Health Q‐9 
X 
 
 
X 
X 
Alcohol Readiness to Change 
X 
 
X 
X 
X 
Delay Discounting task 
X 
 
X 
X 
X 
Cigarette Purchase Task 
X 
 
 
X 
X 
Alcohol Purchase Task 
X 
 
 
X 
X 
Self‐efficacy for Smoking 
X 
X 
X 
X 
 
NSSI checklist 
X 
 
 
X 
X 
Fidelity ratings 
 
X 
 
 
 
Penn Alcohol Craving Questionnaire 
X 
X 
X 
X 
X 
ITASr‐SF 
 
 
X 
 
 
Positive and Negative Expectancies 
X 
X 
X 
X 
X 
Smoking Consequences Questionnaire 
X 
X 
X 
X 
X 
Anxiety Sensitivity Index‐Revised 36 
X 
 
 
X 
X 
OSS 
X 
 
 
X 
X 
Voils Medical Adherence 
 
 
 
X 
 
Timeline Follow Back 
 
 
 
 
X 
PROCESS MEASURES 
Smoking cessation aids 
 
 
X 
X 
X 
Conners’ ADHD Scale  
X 
 
 
X 
X 
Barratt Impulsivity Scale 
X 
 
 
X 
X 
Conners CPT 
X 
 
 
X 
X 
Iowa Gambling Task 
X 
 
 
X 
X 
Balloon Analogue Risk 
X 
 
 
X 
X 
Concurrent Treatment Q 
X 
 
 
X 
X 
NOSIE 
X 
 
 
X 
X 
Medication Adherence 
X 
 
 
X 
X 
Qualitative Interview 
 
 
 
X 
 
Treatment feasibility measure 
 
 
 
X 
 
OUTCOME MEASURES 
Efficacy: Prolonged Abstinence; 7‐day; 30‐day abstinence 
 
 
X 
X 
X 
Quit Attempts 
 
 
X 
X 
X 
Tobacco Exposure Questionnaire 
 
 
 
X 
X 
Time‐line Follow‐Back‐Quit Attempts 
 
 
 
 
X 
*BL=baseline; CBT= phone counseling sessions, PT=post‐treatment/thinning; EM=end of monitoring; 
FUP= 6‐month follow up 
 
To assist in evaluating potential study exclusion for the alcohol withdrawal criterion, we 
have adapted the Clinical Institute Withdrawal Assessment for Alcohol to ask about any 
recent periods of time in which potential participants have abstained from alcohol 
(Sullivan et al., 1989). This will be administered at the screening session. Demographics 
information will be collected at the screening session, and the OSS will be administered 
at the screen, end of monitoring, and 6 month follow up to measure changes in 
occupation status and household income. 
 


Research Summary, version date 3/18/2019 
 
Page 16 of 32 
Smoking‐Related Measures 
The Fagerström Test of Nicotine Dependence (Heatherton, Kozlowski, Frecker, & 
Fagerström, 1991), Questionnaire on Smoking Urges (Tiffany & Drobes, 1991), the 
Minnesota Nicotine Withdrawal Scale (Patten & Martin, 1996), and a smoking history 
questionnaire (e.g., number of cigarettes smoked/day, age of first smoking, number of 
previous quit attempts) will be used to measure smoking behaviors at baseline. In 
addition, the FTND, QSU, Dimensions of Anger Reactions, and Patient Health 
Questionnaire will be administered at the end of Abstinence Induction, end of Thinning 
mCM, and 6‐month follow‐up. Participants will also report number of cigarettes smoked 
each day, and days of smoking abstinence. 
 
Participants will be asked to respond to several questions to determine if the patient is 
contraindicated to receive NRT. Collection of alcohol and smoking use data will allow 
calculation of dual abstinence days and longest duration of dual abstinence. The 
Cigarette Purchase Task will be used to evaluate the behavioral economics of cigarette 
use (MacKillop et al., 2008), and the Alcohol Purchase Task will evaluate the same for 
alcohol use (Acuff & Murphy, 2017). At five time points (baseline, quit date, end of 
abstinence induction, end of treatment, 6 month follow‐up), participants will complete 
the Smoking Consequences Questionnaire, the Penn Alcohol Craving Questionnaire 
(Flannery et al., 1999), and the Alcohol Expectancies measure (Lee et al., 2015). 
 
Treatment Process Measures 
Self‐efficacy will be assessed with the Alcohol Abstinence Self‐Efficacy Scale for alcohol 
(DiClemente, Carbonari, Montgomery, & Hughes, 1994) and the Relapse Situation 
Efficacy Questionnaire for smoking (Gwaltney, 2001). Motivation for smoking cessation 
will be measured with the Motivation to Stop Scale (Kotz, Brown, & West, 2013). 
Attitudes toward behavior change with respect to alcohol and smoking behavior will be 
measured with a brief measure of self‐efficacy for quitting alcohol and the Readiness to 
Change Questionnaire (Heather, Rollnick, & Bell, 1993; Rollnick, Heather, Gold, & Hall, 
1992). In addition, confidence to keep from smoking when craving, facing social 
pressure, or experiencing negative emotion will be measured with the Self Efficacy to 
Overcome Personal Barriers to Cessation scale (Velicer, DiClemente, Rossi, & Prochaska, 
1990). Affective states will be measured with the Positive and Negative Affect Scale 
(Watson, Clark, & Tellegen, 1988). Sleep disturbance will be measured with the 
Insomnia Severity Index (Morin, Belleville, Belanger, & Ivers, 2011). These measures will 
be administered at the baseline visit and administered by phone by study staff at the 
end of Abstinence Induction mCM, end of Thinning mCM, and 6‐month follow‐up 
assessments. At the end of Thinning mCM study session, we will ask participants to 
report on any problems with CO monitoring, especially regarding the validity of 
monitoring. All phone counseling sessions will include assessment of alcohol 
consumption and smoking behavior over the past week, as well as readiness to change 
and self‐efficacy measures for alcohol and smoking. 
 


Research Summary, version date 3/18/2019 
 
Page 17 of 32 
Process measures will include number of telephone counseling sessions completed and 
medication adherence. Medication adherence will be defined as using > 80% of 
prescribed medications, as 80% adherence to NRT has been predictive of doubled 
abstinence at 6 months (Catz et al., 2011). The primary self‐report measure of 
adherence will be the number of days NRT is used during the study period. Days of NRT 
use will be recorded at each telephone counseling call. Participants will also be screened 
for NRT or other smoking cessation aid use at each follow‐up. Participants will complete 
the Voils Medical Adherence Questionnaire to measure adherence to smoking 
pharmacotherapy. We will measure patient satisfaction with a questionnaire tailored to 
this study's treatment aims. 
 
At the end‐of‐treatment visit, each participant will complete a qualitative interview 
aimed at gathering detailed information on strengths, weaknesses and general user 
interface components of the intervention. The interview will vary in length, but we 
expect approximately 30 minutes for participants to provide detailed feedback on the 
intervention in this interview.  
 
Participants will complete the computerized delay discounting task for hypothetical 
monetary values. They will choose between a fixed amount with fixed delay and various 
monetary amounts available immediately (Garcia‐Rodriguez, Secades‐Villa, Weidberg, & 
Yoon, 2013). Delays and monetary options will be presented in ascending order and 
adjusted with procedures that successively approximate an indifference point. The delay 
discounting task will be administered by smart phone app at the baseline screening 
session, the end of Abstinence Induction mCM, end of Thinning mCM, and 6‐month 
follow‐up. To assess the impulsivity mechanism more broadly, we will administer two 
self‐report measures of impulsivity and disinhibition at baseline, end of Thinning mCM, 
and 6‐month follow‐up: the Conners’ Adult ADHD Scale, and the Barratt Impulsivity 
Scale (BIS‐15; Spinella, 2007). We will also administer 3 computerized tasks at office 
vists occurring at baseline, end of Thinning mCM, and 6‐month follow‐up: the Conners 
Continuous Performance Test, the Iowa Gambling Task (Bechara et al., 1994), and the 
Balloon Analogue Risk Task (Lejuez et al., 2002). Anxiety sensitivity will also be 
measured at baseline, end of moritoring, and 6‐month follow‐up using the Anxiety 
Sensitivity Index‐Revised 36 (Taylor & Cox, 1998). Because nonsuicidal self injury (NSSI) 
is not uncommon in persons with alcohol use disorders, especially those with other 
comorbid psychiatric diagnoses, we would like to include a brief measure of NSSI at 
several time points in the study, i.e., baseline and follow‐up visits. This measure will be 
administered to all participants at these time points. Participants can refuse to complete 
the measure. However, in our laboratory’s experience, participants typically do not take 
issue with completing this brief measure. 
 
Treatment Fidelity and Therapeutic Alliance Measurement 
We will utilize a revised version of the Yale Adherence and Competence Scale system to 
measure counselor adherence in delivering behavioral treatments for substance abuse 
disorders (Carroll, 2000). The system includes checklists for measuring critical treatment 


Research Summary, version date 3/18/2019 
 
Page 18 of 32 
elements. A random selection of 20% of the counseling sessions will be recorded and 
rated for counselor fidelity/adherence. Audio recordings of these sessions will be made 
using an iPad or iPhone (see “Protection Against Risk and Data Security Measures” 
herein for additional information); only the therapist’s voice will be recorded during the 
conversation. To measure therapeutic alliance, the 16‐item Individual Treatment 
Alliance Scale Revised Short Form (ITASr‐SF) will be utilized. The ITASr‐SF has been 
shown to be related to treatment dropout and treatment response in behavioral 
interventions (Pinsof, Zinbarg, & Knobloch‐Fedders, 2008). This will be administered 
during the end of Abstinence Induction mCM phone session.  
 
Potential Risks 
 
There is a risk of discomfort or distress in answering questions on the study measures. 
However, distress and discomfort related to questionnaire completion is usually 
temporary and well‐tolerated. Risks also include discomfort related to alcohol 
withdrawal and quitting smoking. Symptoms of alcohol withdrawal may include 
headache, insomnia, sweating, shakiness, and rarely, seizures or hallucinations. We will 
minimize risk of alcohol withdrawal by screening participants at high risk for withdrawal 
out of the study. However, in case enrolled patients experience alcohol withdrawal that 
is not reported at the screening visit, we will instruct patients to report symptoms to 
research staff. The physician prescriber will have the flexibility to adjust medications as 
needed to account for changes in clinical variables such as withdrawal, craving, and 
smoking lapse pattern. Participants will be encouraged to utilize emergency resources at 
Duke as needed to address these symptoms.  
 
Quitting smoking may cause difficulty concentrating, poor sleep, increased appetite, 
anxious or depressed mood, and craving for cigarettes. Participants will be offered NRT, 
and there are risks associated with the use of NRT. Minimal risks associated with 
wearing a nicotine patch include skin irritation, dizziness, lightheadedness, increased 
heart rate or blood pressure, nausea or vomiting. If a participant indicates a 
contraindication to NRT (e.g. uncontrolled hypertension), medical clearance for NRT will 
be sought from the participant’s primary care physician and/or the study physician. If a 
participant with a seizure disorder, history of or current hepatitis and/or cirrhosis, renal 
impairment, and/or uncontrolled diabetes wishes to enroll in the study, he/she will not 
receive contraindicated medications.  
 
Participants who are medically eligible will also be prescribed bupropion SR. Risks of 
bupropion use include dry mouth, insomnia, nausea, constipation, headache, shakiness 
or jitteriness, skin rash, sweating, allergic reaction, change in appetite, weight loss, 
dizziness, tremor, thinking abnormally, hot flashes, worsening depression or suicidal 
thoughts and behavior, and ringing in the ears. At the highest dosage of bupropion to be 
used in this study, seizures occurred in 1 out of every 1000 (0.1%) who took this drug. 
Participants are informed that they are not required to take bupropion, and will be 
allowed to participate in the study if they refuse to do so.  


Research Summary, version date 3/18/2019 
 
Page 19 of 32 
 
There is a potential risk associated with the loss of confidentiality of study data. 
Specifically, collection and transfer of videotaped carbon‐monoxide monitoring have 
risks with regards to privacy and confidentiality. Please see “Protection Against Risk and 
Data Security Measures” for details on reduction of risk with regards to the proposed 
videotaping. 
 
Protection Against Risk and Data Security Measures 
 
While participants may benefit from quitting smoking and alcohol use, there are no 
guaranteed benefits to the individual participant and no immediate benefits of the 
proposed research to others. There are potential benefits to others from the 
information generated that potentially will be helpful in developing new combined 
treatments for smoking and alcohol use. In our opinion, the anticipated benefits of this 
study outweigh the potential risks.  
 
The study is completely voluntary and participants are informed that they are free to 
refuse to answer any items on the questionnaires or questions from the interview that 
they do not wish to answer. They are also informed that they are free to decline 
participation in any procedure and can withdraw from the study at any time. 
 
Potential risks will be minimized by carefully screening potential participants according 
to the inclusion/exclusion criteria, closely monitoring symptom levels, and following 
established laboratory procedures associated with participant safety.  
 
If at any laboratory visit the participant’s breathalyzer results are above the legal limit 
and he/she has driven to the appointment, we will advise the participant not to drive 
home. We will encourage him/her to use the local bus system, call for someone to pick 
him/her up, or call a taxi. The study coordinator will help the participant to make these 
telephone calls. However, due to budgetary limitations, the study will not provide 
monetary assistance to these participants who require alternative transportation 
methods. If a participant is unwilling to arrange alternate transportation, we will 
encourage him/her to remain at the medical center for a period of time until he/she 
does not meet legal criteria for intoxication. If a patient does not wish to remain at the 
medical center, and voices intent to drive a vehicle while intoxicated, we will notify the 
Duke police. 
 
We will be providing the study phones to participants for the course of the monitoring 
period and will retrieve them at the conclusion of monitoring. We will restrict access to 
the following applications: internet browsers, installation of apps, deletion of apps, and 
in‐app purchases. We will prevent access to music, podcasts, movies, TV shows, apps, 
and other websites. We will prevent ability to change the following: accounts, cellular 
data use, background app updates, location services, contacts, calendars, reminders, 
photos, Bluetooth sharing, microphone, Twitter, Facebook, and advertising. We will 


Research Summary, version date 3/18/2019 
 
Page 20 of 32 
have the ability to remote wipe the phones if they are not returned. We will encourage 
participants via consent to only enter information on the phone that they are 
comfortable with sharing with the entities listed below.    
 
Regarding mobile information security, we have taken care in previous projects using 
similar methods and technology to develop procedures to limit the risk of breach of 
confidentiality and privacy. For example, the smart phone is programmed such that a 
staff member will set up the telephone and enter the participant’s code into the phone. 
When uploading a video, participants upload directly from the phone to an approved 
website that has been vetted by Duke’s information security officers, and the phone 
programming ensures that the video is uploaded into the correct participant’s area of 
the website. This ensures that study participants’ data is stored in the correct place, and 
that study participants cannot view any other participants’ data. Participants are asked 
to review their videos before posting, and they can choose not to upload any video that 
they don’t wish to upload for any reason. In previous studies that have been run using 
this methodology, we have had no participant complaints regarding issues of privacy 
and confidentiality related to use of the smart phone videotaping procedures. In order 
to enhance participants’ privacy, we will restrict access to several of the telephone’s 
ancillary applications, and we have the ability to remotely delete data from any phones 
that are not returned to the study team. 
 
For the study’s website, we will use shared server space provided by InMotion Hosting, 
Inc (website www.Calhounlab.com). We will be using AES‐256‐CBC encryption with SHAI 
for message authentication and RSA as the key exchange mechanism. The video 
recordings will be collected on devices that are FIPS‐140‐2 compliant. The data at rest at 
InMotion Hosting is AES‐256 encrypted at rest, and the data being transferred are 
encrypted at transfer (AES‐256). Data will be unencrypted only by study staff members 
who have access to the secured server at InMotion Hosting; the encryption key is held 
only by our staff. This will ensure all video uploads and data that the participant sends 
over the internet via their phones will only be transferred over encrypted network 
connections, essentially nullifying the possibility of someone gaining access to the video 
before it reaches our server. InMotion also runs audits regularly of the websites hosted 
within their shared servers to prevent scriptside vulnerabilities, as well as having a 24/7 
support team monitoring their servers. The web application written for this study has 
been checked for SQL injection, Code Injection, XSS, and RFI vulnerabilities and has 
passed. The site will only be accessible by the study participants and the study 
coordinators via 512‐bit SHA‐2 hashed passwords. 
 
In previous studies using this methodology that have been run in the Traumatic Stress 
and Health Research Laboratory, we have had no participant complaints regarding 
issues of privacy and confidentiality related to use of the smart phone videotaping 
procedures. As security controls have not been validated for InMotion Hosting, we will 
include a statement in the informed consent that the data/videos voluntarily submitted 
will be sent to InMotion and are no longer covered by Duke privacy protections. 


Research Summary, version date 3/18/2019 
 
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Audio recordings of counseling sessions and qualitative interviews will be made using a 
Duke‐owned iPhone or iPad that is encrypted at levels compliant with FIPS 140‐2 
standards. The device to be used will be hardened such that only the video recording 
capability will remain. Recordings will be moved from the device to the Duke shared 
server (duhsnas‐pri\dusom_psych\private\Beckham Research Lab\mCM for Alcohol and 
Smoking) as soon as possible after the recordings have been made, and will then be 
deleted from the mobile device. Any device that is not in use will be stored in a locked 
filing cabinet in Dr. Dedert’s office. Recordings of therapy sessions will remain on the 
Duke shared drive until they are evaluated for fidelity, and recordings of qualitative 
interviews will remain there until they have been analyzed for content. After this 
review, recordings will be copied to an encrypted external hard drive for permanent 
storage. The encrypted hard drive will be stored in a locked file cabinet in Dr. Dedert’s 
lab space at Hock Plaza. Only the key personnel listed on the staff listing will have access 
to the encryption password and/or the hard drive. 
 
No “key personnel outside Duke” will have access to identifying information on subjects. 
Two key personnel outside Duke will provide consultation to Dr. Dedert and his study 
staff. Stephen Maisto, Ph.D., SUNY Upstate Medical University, is a clinical psychologist 
with expertise in developing evidence‐based behavioral interventions for alcohol use 
disorders and hazardous alcohol use. He has also conducted research into alcohol 
treatment process and outcome measurement. Dr. Maisto will have primary 
responsibility for training Dr. Dedert and study staff on the phone counseling portion of 
the intervention. Daniel Kivlahan, Ph.D. is a clinical psychologist with the Department of 
Veterans Affairs. He has expertise in clinical research on alcohol and implementation of 
new treatments for alcohol and substance use disorders. Dr. Kivlahan will provide 
insight into telephone counseling for alcohol misuse as well as assist in the development 
and refinement of the treatment, and consult on the measurement of alcohol 
outcomes.  
 
Data that links participants to information collected in the course of a given study will be 
kept separately from identifying information in an electronic, password‐protected MS 
Access database stored at duhsnas‐pri\dusom_psych\private\Beckham Research 
Lab\mCM for Alcohol and Smoking; the key connecting identifying information and data 
will be stored here as well. Hard copy paper records will be stored in a locked filing 
cabinet in the study coordinator’s locked office, within Dr. Beckham’s laboratory space 
at Duke University Medical Center South. Information from the interview and/or 
questionnaires may be entered into a computerized database that will be stored on the 
DUMC server at duhsnas‐pri\dusom_psych\private\Beckham Research Lab\mCM for 
Alcohol and Smoking in a password‐protected database separate from the “logbook” of 
identifying information. This database is accessible only by Dr. Beckham and study staff. 
Any staff members who leave the study for any reason will have access to study 
resources, including data, removed immediately. 
 


Research Summary, version date 3/18/2019 
 
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The study’s safety monitoring plan is based on long‐term clinical and research 
experience with patients with psychiatric illness, and is explained in more detail in the 
“Data and Safety Monitoring Plan” section. All project staff will complete educational 
units required by Duke’s IRB, including CITI training and DSRT training. 
 
Staff Training 
 
Of the measures in this study, only the SCID and the qualitative data interview require 
specific training or skills for administration. As in our other studies, multiple SCID 
diagnostic raters will be utilized over the data collection period. Each rater will be 
trained using SCID standardized training (i.e., manual, videotapes, and co‐rating training 
with a trained rater). Interrater reliability for diagnoses based on videotapes of patient 
interviews across previous studies has been high with a kappa = .96. Additionally, staff 
providing these diagnostic interviews are trained in use of the Psychiatric Emergency 
Standards of Practice. Training is completed and supervised by a Master’s level clinician 
with experience in psychiatric diagnosis, or by Ph.D. level clinical psychologists. Regular 
clinical supervision is provided on a monthly basis in team meetings, and consultation is 
provided regularly to interviewers. 
 
The qualitative data interview will be administered by an experienced clinical 
interviewer with an advanced degree (masters or doctoral). Interview sessions will be 
audio recorded to permit detailed analysis of participant comments and ensure that 
interviews are conducted skillfully and with respect for participant rights. Audio 
recordings are made using an encrypted iPad or iPhone; see “Protection Against Risk 
and Data Security Measures” herein. 
 
Data and Safety Monitoring Plan 
 
Quitting smoking and alcohol use should enhance rather than jeopardize health status, 
and potential serious adverse events (SAEs) for participants in this project are not 
expected. Regardless, we will minimize potential risk by careful screening of potential 
participants (e.g., medical clearance by their primary care provider if there are 
contraindications to smoking cessation pharmacotherapy). 
 
The individuals responsible for data safety and monitoring will be the PI, the project 
manager, and the Study Physician. The Study Physician for this trial will be Scott Moore, 
M.D., Ph.D. Dr. Moore is a board certified general psychiatrist, and is the treating 
physician of the local VA Medical Center’s specialty smoking cessation clinic. As the 
Study Physician, Dr. Moore will ensure participants are medically cleared to participate 
in this trial and will review all reports of adverse events (AEs) sent by the study 
coordinator and evaluate the patient as necessary to determine whether there is any 
corrective action needed. 
 


Research Summary, version date 3/18/2019 
 
Page 23 of 32 
Further data safety and monitoring will be provided by the PI. There will be several 
ongoing mechanisms for monitoring and reporting of AEs: 1) ongoing participant contact 
via study personnel, 2) a phone number provided to participants to report concerns 
related to study participation; 3) weekly meetings between the PIs and study personnel. 
 
The PI will meet at least weekly with study personnel to discuss participants’ reactions 
to the intervention, proper delivery of the intervention, and any adverse events or 
unanticipated problems. Regular meetings between investigators and the project 
manager will allow for ongoing progress reports, including the number of participants 
currently involved in the study groups, attrition rates, and scheduled data collection 
from participants, as well as notification and review of any AEs. Safety monitoring for 
AEs will be conducted in real time by the PI and/or project manager. The following 
information about adverse events will be collected: 1) the onset and resolution of the 
AE, 2) an assessment of the severity or intensity (use existing grading scales whenever 
possible), 3) an assessment of the relationship of the event to the study (definitely, 
probably, possibly or not related), and 4) action taken (e.g., none, referral to physician, 
start or increase concomitant medication). The PI will determine the severity of the 
event, will assign attribution to the event, and will monitor the event until its resolution. 
Any adverse events will be reported to the IRB in accordance with the IRB guidelines.  
 
Plans for Responding to a Participant Who Expresses Suicidal Ideation 
 
Our research laboratory has established, DUMC IRB‐approved standards of practice for 
the evaluation of risk of suicide and homicide. The policy includes a thorough risk 
assessment including evaluation of risk factors and protective factors associated with 
both suicide and homicide. Also included in the policy are differential recommendations 
for action based on determinations of low, moderate, or high risk. Any staff member 
conducting an interview in which moderate or high risk is determined will contact a 
senior staff person with clinical expertise in risk assessment. 
 
Outcome Measurement and Biochemical Verification 
 
Self‐reported and bioverified prolonged abstinence from alcohol, smoking, and dual 
abstinence at the 6‐month follow‐up will be the primary end‐point. Prolonged 
abstinence will exclude substance use in the first two weeks following the quit date to 
give participants time to achieve initial abstinence (Hughes et al., 2003). Self‐reported 
prolonged abstinence will be verified by breathalyzer alcohol assessment and assay of 
cotinine, a metabolite of nicotine in the saliva. Saliva samples will be collected from 
participants at end of treatment, and at 6‐month follow‐ups. Deidentified saliva samples 
will be sent to Salimetrics, and there they will be analyzed for the presence of cotinine 
using a standard cut point of 10 ng/ml to determine abstinence. A blind sample of 5% 
will be run again to assure test accuracy of saliva samples. All participants will be asked 
to provide saliva samples. However if it seems likely that they will have a positive saliva 
cotinine according to the Tobacco Exposure Questionnaire administered at end of 


Research Summary, version date 3/18/2019 
 
Page 24 of 32 
monitoring at 6‐month follow‐up, the collected sample may not be sent to Salimetrics 
for testing. 
 
Participants will also report alcohol consumption patterns such as standard 
drinks/week, heavy drinking episodes (drinking enough so that BrAC would have 
reached 0.08g/dL), proportion of days abstinent, and achieving recommended drinking 
limits (<14 drinks/wk and <5 drinks/day for men; <7 drinks/wk and <4 drinks/day for 
women). Because bioverification of long‐term alcohol abstinence is not substantially 
more reliable than self‐report (Babor, Steinberg, Anton, & Del Boca, 2000), alcohol 
outcomes will primarily be assessed with self‐report. Participants will provide 
breathalyzer verification of alcohol abstinence at the end of Thinning mCM and 6‐month 
follow‐up visits. Participants will also report number of cigarettes smoked each day, and 
days of smoking abstinence. Collection of alcohol and smoking use data will allow for 
calculation of dual abstinence days and longest duration of dual abstinence. Participants 
will be asked to submit a saliva sample for biochemical validation. Saliva will be stored in 
a freezer in a locked office. At the end of the study, the project coordinator will 
personally mail all saliva samples to the appropriate laboratory to be analyzed for the 
presence of cotinine. The saliva will only be tested for cotinine, a by‐product of nicotine. 
This method yields response rates that are comparable to in‐person collection methods 
(i.e., 70%). A standard cut‐point of 10 ng/ml will be used to discriminate those who are 
abstaining from those who are continuing smokers.  
 
Prolonged abstinence from alcohol will be assessed using phosphatidylethanol (PEth) as 
a biomarker at the 6‐month follow‐up visit. While self‐report abstinence has been a 
proven indicator, bioverification using PEth testing is an effective tool for identifying 
heavy drinking (Nanau & Neuman, 2015) , and has a 99% sensitivity for detecting 
excessive alcohol consumption (Aradottir et al., 2006). This will be assessed using a 
dried blood spot collection, collecting 3 spots (about 3 mL) of blood from the 
participants’ finger. PEth testing has been shown to have. The de‐identified test card will 
be collected by ARCpoint labs of Raleigh Durham for analysis. All sharps and 
biohazardous material will be collected and disposed of by ARCPoint labs. 
 
Data Analyses  
 
Descriptive statistics will be used to summarize all study variables. For continuous 
variables, means, standard deviations, percentiles, ranges, box plots and histograms will 
be generated. For categorical variables, frequencies and proportions will be generated. 
We will construct individual and mean trajectory plots of the longitudinal outcome 
variables to understand their general trends over time (i.e., post‐treatment, 6 weeks 
and 6 months). Differences in treatment outcomes will be tested via generalized linear 
modeling. In addition, we will explore the variability and correlation structure of 
longitudinal variables. We will examine all variables to determine if parametric 
distributional assumptions (e.g. normality for the continuous variables) are valid. 
Variables not meeting distributional assumptions will either be transformed or modeled 


Research Summary, version date 3/18/2019 
 
Page 25 of 32 
using nonparametric or semi‐parametric methods (e.g. quasi‐likelihood methods). In 
planning a full RCT of the tele‐health mCM intervention for AUD and smoking, it is 
important to evaluate study feasibility and treatment procedures, as well as gain 
information about effects on proposed outcome variables.  
 
Specific Aim 1: Develop a multi‐component alcohol and smoking tele‐health mCM 
intervention.  
 
Content analysis of the cohort interviews will yield descriptive data regarding 
participants' perceptions of specific components of the treatment at each development 
phase. The first cohort will identify unanticipated problems with treatment procedures 
and equipment, clarify the change process and potentially identify new variables to 
examine as treatment mechanisms, and serve as a check on the appropriateness of the 
selected outcome measures. Participant feedback will also be critical in evaluating the 
user experience so that the phone app and phone counseling procedures can be 
enjoyable to the target population. Though the perspective of each participant in the 
first cohort will be strongly considered, negative feedback about an aspect of the 
intervention from one participant will be weighed against the feedback from others and 
the theoretical underpinnings of the treatment before the research team makes 
changes to the treatment. For example, if any participants note difficulty 
comprehending a treatment component or message, that component will be modified 
for clarity, as that does not conflict with the theoretical approach. Similarly, we will 
consider changes to the sequencing of phone counseling. PIs will meet weekly with the 
phone counselor to discuss narrative summaries of cases and the strengths and 
weaknesses of the treatment, as well as ease of manual use.  
 
Specific Aim 2: Evaluate the feasibility and acceptability (e.g., mCM app reliability, 
mCM app procedures completion, patient satisfaction) of a tele‐health mCM 
intervention; relative to a comparison group receiving a tele‐health intervention 
without mCM. 
 
We will additionally explore differences in alcohol and smoking abstinence outcomes by 
treatment. Because the tele‐health only intervention is expected to have a uniformly 
small impact on alcohol and smoking outcomes in comparison to the tele‐health mCM 
intervention, implementation of an imbalanced‐samples design, with twice as many 
participants randomized to the tele‐health mCM treatment as to the tele‐health only 
treatment, should maximize power for identifying treatment effects. That said, the 
proposed sample has 80% power to detect a treatment effect equivalent to Cohen’s d = 
0.76. For reference, in our pilot study of 22 smokers with PTSD, tele‐health mCM yielded 
an effect size of Cohen’s d = 0.79 at the 3‐month follow‐up. In particular, comparisons 
by treatment at post‐intervention, 6 week follow‐up, and 6‐month follow‐up will be 
made regarding alcohol consumption (drinks/week, number of heavy drinking episodes, 
proportion of days abstinent, and achieving recommended drinking limits) and smoking 
(number of cigarettes smoked each day and number of days of smoking abstinence) via 


Research Summary, version date 3/18/2019 
 
Page 26 of 32 
generalized linear modeling, which can accommodate normally and non‐normally 
distributed (e.g., count) variables.  
 


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Page 27 of 32 
References 
 
Acuff, S. F., & Murphy, J. G. (2017). Further examination of the temporal stability of 
alcohol demand. Behavioural Processes, 141, 33‐41. 
doi:10.1016/j.beproc.2017.03.020. 
Babor, T.F., Steinberg, K., Anton, R., & Del Boca, F. (2000). Talk is cheap: Measuring 
drinking outcomes in clinical trials. Journal of Studies on Alcohol, 61, 55‐63. 
Bechara. A., Damasio, A.R., Damasio, H., Anderson, S.W. (1994). Insensitivity to future 
consequences following damage to human prefrontal cortex. Cognition, 50, 7‐15. 
Bush, K., Kivlahan, D. R., McDonell, M. B., Fihn, S. D., & Bradley, K. A. (1998). The AUDIT 
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Carpenter, V. L., Hertzberg, J. S., Kirby, A. C., Calhoun, P. S., Moore, S. D., Dennis, M. F., . 
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ICF_001.pdf: 
Mobile Contingency Management for Concurrent Abstinence From Alcohol 
and Smoking 
NCT02995915 
Informed Consent Forms 
Document Date: 9/11/2018 


 
 
 
 
Consent to Participate in a Research Study 
Mobile Contingency Management for Concurrent  
Abstinence from Alcohol and Smoking (Stage 2) 
 
Page 1 of 15 
Subject*Initials_________
DUKE UNIVERSITY HEALTH SYSTEM
Form
M0345
 
You are being asked to take part in this research study because you smoke and drink alcoholic beverages 
and wish to quit. Research studies are voluntary and include only people who choose to take part.  
Please read this consent form carefully and take your time making your decision. As your study doctor 
or study staff discusses this consent form with you, please ask him/her to explain any words or 
information that you do not clearly understand.  We encourage you to talk with your family and friends 
before you decide to take part in this research study.  The nature of the study, risks, inconveniences, 
discomforts, and other important information about the study are listed below. 
 
Please tell the study doctor or study staff if you are taking part in another research study. 
 
A grant from the National Institutes of Health (NIH) will sponsor this study.  Portions of Dr. Dedert’s 
and his research team’s salaries will be paid by this grant. 
 
CONCISE SUMMARY
 The purpose of this study is to learn more about ways to help people quit smoking and drinking 
alcohol. This study is looking specifically at the use of monetary rewards and a smart phone 
application for smoking and alcohol cessation. 
If you are eligible to participate in the study, we will randomly assign you to one of two groups 
using a process like drawing a number out of a hat. No matter which group you are assigned to, you 
will receive counseling sessions, medications to help you quit smoking, and mobile technology to 
monitor your drinking and smoking. If you are assigned to the mobile contingency management 
group, you will receive additional incentives to quit smoking and drinking alcohol. In this group, 
you are paid if your home monitoring suggests that you have been abstinent from smoking and/or 
drinking. 
If you participate in the study, there may be a direct benefit to you. You may benefit from stopping 
smoking and drinking alcohol, but this benefit is not guaranteed. Risks of the study include smoking 
withdrawal symptoms and alcohol withdrawal symptoms. There are also some risks involved in 
taking the study medications, including risk of nausea and skin irritation with nicotine patch use. 
The most common side effects of bupropion include dry mouth, trouble sleeping, and nausea. 
Your active participation in the study will last about eight weeks. You will have a follow-up session 
six months after your smoking and alcohol quit date. Altogether, your participation will last about 7 
½ months. 
If you are interested in learning more about this study, please continue to read below.
DUHS IRB
IRB NUMBER: Pro00062101
IRB APPROVAL DATE: 09/11/2018
IRB EXPIRATION DATE: 09/23/2019


 
 
 
 
Consent to Participate in a Research Study 
Mobile Contingency Management for Concurrent  
Abstinence from Alcohol and Smoking (Stage 2) 
 
Page 2 of 15 
Subject*Initials_________
DUKE UNIVERSITY HEALTH SYSTEM
Form
M0345
WHO WILL BE MY DOCTOR ON THIS STUDY? 
If you decide to participate, Drs. Scott Moore and Eric Dedert will be your doctors for the study and will 
be in contact with your regular health care provider throughout the time that you are in the study and 
afterwards, if needed. 
 
WHY IS THIS STUDY BEING DONE? 
The purpose of this study is to learn more about ways to help people quit smoking and drinking alcohol. 
This study is looking specifically at the use of monetary rewards and a smart phone application, or app, 
for smoking and alcohol cessation. 
 
HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY? 
Approximately 70 people will take part in this study at Duke. 
 
WHAT IS INVOLVED IN THE STUDY? 
This table summarizes the study procedures, and they are also described in detail in the text. 
 
Table 1. Study Procedures 
 
Session 
# 
Location of 
Visit 
Procedures 
Payment 
1 
Lab 
Consent; psychiatric interview; 
questionnaires; urine drug screen and 
pregnancy test; carbon monoxide 
and breath alcohol readings 
$50  
1-3 weeks 
2 
Phone 
Counseling session 1 of 4 
n/a 
1 week 
3 
Phone 
Counseling session 2 of 4; begin 
practice mCM monitoring, begin 
bupropion if eligible 
Up to $34 for 
monitoring 
1 week 
4 
Phone 
QUIT DATE; counseling session 3 
of 4; begin active mCM monitoring 
OR active mobile monitoring; begin 
nicotine replacement therapy (NRT) 
n/a 
2 weeks 
5 
Phone 
Counseling session 4 of 4; continue 
active mCM monitoring OR active 
mobile monitoring 
n/a 
1 week 
DUHS IRB
IRB NUMBER: Pro00062101
IRB APPROVAL DATE: 09/11/2018
IRB EXPIRATION DATE: 09/23/2019


 
 
 
 
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Mobile Contingency Management for Concurrent  
Abstinence from Alcohol and Smoking (Stage 2) 
 
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Up to $702 (mCM) 
OR $132 (MM) for 
active monitoring;  
6 
Phone 
End active monitoring; begin wash-
out monitoring in mCM group; 
questionnaires 
$50 for assessment 
2 weeks 
Up to $400 (mCM) 
OR $88 (MM) for 
continuing 
monitoring 
7 
Lab 
End monitoring; return equipment; 
questionnaires; end NRT and 
bupropion; saliva sample; interview 
about treatment 
$35 for equipment 
return; $50 for 
assessment; $50 for 
saliva sample 
6 months after Session 4 
8 
Lab 
Questionnaires; saliva sample; blood 
spot collection 
$50 for assessment, 
$50 for saliva 
sample, $50 for 
blood spot test 
TOTAL 
COMPENSATION 
POSSIBLE: 
mCM Group 
Mobile Monitoring 
 
$1521* 
$639* 
*because compensation depends partly on the number of alcohol breathalyzer prompts that are randomly 
generated, it is possible that the total maximum compensation will vary slightly. 
 
Session 1: If you agree to be in this study, you will be asked to sign and date this consent form. We will 
ask you to do the following tests and procedures to make sure that you are eligible:  
 provide a breath sample by blowing into a device that measures the amount of carbon monoxide 
(CO, a gas found in your breath) in your breath, which will indicate how much you are smoking; 
 participate in an interview about your current mental health; and  
 provide a urine sample so that we can test for substances such as cocaine, heroin, and 
amphetamines. If you are a woman of child-bearing age and/or potential, we will also use this 
urine to perform a pregnancy test. If the urine pregnancy test is positive, you will not be allowed 
to continue study participation. 
 
We will ask you to fill out some questionnaires about yourself. These will include questions about your 
substance use, mood, any self-injurious behaviors, beliefs, and your smoking history.  
 
DUHS IRB
IRB NUMBER: Pro00062101
IRB APPROVAL DATE: 09/11/2018
IRB EXPIRATION DATE: 09/23/2019


 
 
 
 
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Mobile Contingency Management for Concurrent  
Abstinence from Alcohol and Smoking (Stage 2) 
 
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If the screening session results in your being enrolled in the study, you will be randomly assigned to one 
of two treatment groups using a process like drawing a number out of a hat. If you are assigned to the 
first group, you will receive the “Mobile Monitoring” treatment to help you stop drinking alcohol and 
smoking cigarettes. This treatment includes counseling sessions, medications, and a mobile technology 
for you to use in monitoring your alcohol drinking and cigarette smoking behaviors. If you are assigned 
to the “Mobile Contingency Management” group, you will receive the same treatment, except that the 
amount of money you receive as compensation for providing video of tests of your alcohol drinking and 
cigarette smoking behaviors using the mobile health technology will depend on providing test values 
indicating that you have abstained from alcohol and cigarettes. You have a 2 out of 3 chance of being 
assigned to the “Mobile Contingency Management” group.  
 
If you are enrolled, you will be given a CO monitor, breathalyzer, and mobile telephone to take home 
for several weeks. You will use this equipment to monitor yourself taking CO readings twice per day at 
least 8 hours apart. You will also use the equipment to monitor yourself taking breathalyzer readings 
when prompted by alarms from the mobile telephone, and upload them to the study team. The mobile 
telephone has a small video camera. You will be trained how to use the CO monitor and breathalyzer, 
and how to use the telephone to record yourself using the monitors. You will also be trained how to 
upload the video to this study’s website using a mobile application (mCM) that will be on the phone 
you’re given.  You will begin practicing monitoring after this appointment. Between session 1 and 
session 3 (up to four weeks), you will practice monitoring to make sure you have learned how to 
complete monitoring procedures, but you will not be paid for monitoring. 
 
At the end of the study, we will ask you to return the study equipment to the study staff. If you misplace 
the study equipment, or it is stolen while you have it, we ask you to tell a study staff member 
immediately. The telephone has tracking software on it, and we may be able to use the software to locate 
the phone, shut it down, and get all of the data you have stored on it. We will only use the tracking 
software if you report the telephone as lost or stolen, or you fail to return it to us at the end of the study. 
If your telephone or other equipment has been misplaced or stolen, and you still need the equipment to 
continue in the study, we will provide you with a replacement at no cost.  
 
All together, this visit will take about 5 ½ hours to complete. We will pay you $50 for completing this 
session. 
 
Session 2: No matter which treatment group you get as your assigned group, session 2 occurs sometime 
in the first three weeks after Session 1, depending on how long it takes to arrange medications to help 
with your quit attempt. In this phone session, you will participate in the first of four counseling sessions 
designed to prepare you for quitting smoking and drinking alcohol. Each of your phone counseling 
sessions will be audio recorded using an iPad or iPhone. About one in five of your sessions will be 
reviewed by a study staff member to ensure that the phone counseling treatment is being done correctly. 
The recording will be moved from the recording device to a Duke secured server. You will not be paid 
for Session 2. 
DUHS IRB
IRB NUMBER: Pro00062101
IRB APPROVAL DATE: 09/11/2018
IRB EXPIRATION DATE: 09/23/2019


 
 
 
 
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Mobile Contingency Management for Concurrent  
Abstinence from Alcohol and Smoking (Stage 2) 
 
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Session 3: Session 3 occurs about one week after Session 2. If you are medically eligible, we will give 
you a medication to begin taking one week before your smoking quit date. The medication is bupropion 
SR, an antidepressant medication that is FDA approved for treating depression and for helping smokers 
to stop smoking. Before we give you this medication, though, we will make sure you are medically 
eligible to take it. To do that, we may attempt to contact your primary care doctor and/or other treating 
doctor in order to consult with him/her prior to your beginning the medication. If you indicate that you 
have any contraindications to taking the study medication, we will definitely try to contact your 
physician so that he/she can make an informed decision. If you have ever had seizures or currently have 
seizures, please tell the study coordinator. You should not take bupropion if you have uncontrolled 
diabetes, kidney impairment, current or past hepatitis, or current or past cirrhosis. You will still be 
allowed to participate in the rest of the study if your doctor or the study doctor determines you shouldn’t 
take bupropion. You will take 150 mg each day for 7 days and then 300 mg each day and continue 
taking the medication for seven weeks. If you would like to continue using bupropion after this eight 
week period, you will need to speak with your personal doctor about a prescription. You will also be 
given two forms of nicotine replacement therapy, or NRT. This includes nicotine patches and a “rescue 
method,” like nicotine gum or lozenges. We’ll ask you what you prefer. You will be asked to begin 
using these medications on your quit date. 
 
No matter which treatment group you get as your assigned group, starting at Session 3 and lasting until 
Session 7, you will be asked to record and upload your breath alcohol readings each time you hear an 
alarm on your phone. The study phone will send text messages to your personal cell phone each time 
that the alarm sounds. You can opt out of receiving text messages on your personal phone at any time. 
This will happen on average about ten times per week. You will be asked to upload your CO readings 
twice per day with at least eight hours between the readings. You can do the CO readings at whatever 
time you choose. The study’s website will include a personalized study area for you. The study area will 
allow you to see how many readings have been uploaded, and will provide information about monetary 
rewards for your readings. For the first week of monitoring (between session 3 and 4), you will be paid 
$1.00 for each CO reading that you upload regardless of how high or low your CO reading is. You will 
be paid another $2.00 for each breath alcohol reading you upload. In sum, for this practice week of 
monitoring you can earn up to $34 for uploading your readings. 
 
Session 4: This session will occur on your quit date. You will participate in the third counseling session. 
You will be asked to start using nicotine patches and your preferred rescue method. Also, you’ll be 
asked to continue home monitoring. If you are assigned to the Mobile Monitoring group, you will 
continue to be paid regardless of how high or low your alcohol and smoking test readings are. This 
means you will be paid $1.00 for uploading each CO reading video, and $3.00 for uploading each 
breathalyzer reading video within the one hour time period after an alarm. 
 
However, if you are assigned to the Mobile Contingency Management group, starting at this session, 
you will only receive payments for uploading videos that indicate you haven’t been smoking and/or 
drinking. For example, if you upload a video that indicates that you are still smoking, you won’t get paid 
DUHS IRB
IRB NUMBER: Pro00062101
IRB APPROVAL DATE: 09/11/2018
IRB EXPIRATION DATE: 09/23/2019


 
 
 
 
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Mobile Contingency Management for Concurrent  
Abstinence from Alcohol and Smoking (Stage 2) 
 
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for the smoking video. Abstinent readings are breathalyzer readings that are < 0.02 BrAC and CO 
readings that are based on reductions from your baseline value for the first week, and are < 6 parts per 
million after the first week of the quit attempt. Your beginning payment for uploading an alcohol 
breathalyzer video that shows you haven’t been drinking is $3.00. Your beginning payment for 
uploading a CO reading video that shows you haven’t been smoking is $1.00. If you upload videos that 
suggest that you are abstinent from both alcohol and smoking, you will be paid a bonus payment. On 
Sundays through Wednesdays, that bonus will be $5.00. On Thursdays through Saturdays, that bonus 
will be $10.00. The amount that you earn for uploading “clean” readings will increase each time, as long 
as you continue to remain abstinent. If you upload a “dirty” reading (i.e., the number on the monitor 
indicates that you have been using that substance) or do not respond to the alarm, the amount of 
payment will be reset back to the original amounts ($3 and $1). However, after you’ve had three “clean” 
readings, we will reset your payment to the higher amount you were making before. The payment 
schedule for monitoring is complicated, but the study coordinator will provide you with a manual that 
explains it in detail. Actual payment for monitoring will be provided after session 7. 
 
Session 5: Session 5 will occur about two weeks after session 4. In this session, you will have your final 
counseling session, where your counselor will talk to you about strategies for remaining smoke-free. 
You will be asked to continue at-home monitoring. You are not paid for Session 5, but you may be paid 
for “clean” monitoring readings if you are in the Mobile Contingency Management group. You may be 
paid for any monitoring readings if you are in the Mobile Monitoring group. 
 
Session 6: This session will occur about one week after session 5. In this session, the study coordinator 
will ask you some questions about your symptoms and about the treatment, and you will complete some 
questionnaires. You will be paid $50 for completing this session over the phone.  
 
If you are in the Mobile Management group, you will continue to upload videos and payment will 
remain the same. If you are in the Mobile Contingency Management Group, will be asked to continue 
monitoring, but the payment scheme for monitoring will change. Between sessions 6 and 7 (two weeks), 
you are paid $200 at the end of each week if you upload at least 90% of all possible videos for the week 
with clean readings. If you are abstinent from only one substance but have uploaded at least 90% of 
videos for that week, you will earn $50. 
 
Session 7: This session will occur about two weeks after session 6. You will be asked to return the CO 
monitor, the breath alcohol monitor, and the telephone, and to stop doing at home-monitoring. You will 
be asked to complete some questionnaires about the treatment you received and about smoking and 
alcohol use. The study coordinator will also interview you about your experiences with the treatment 
you received. This interview will be audio-recorded using an iPad or iPhone. You will be asked to stop 
using bupropion and NRT. However, if you’re still smoking and would like to try to make another quit 
attempt, you may be allowed to continue using NRT. We will ask you to provide a saliva (spit) sample. 
You can choose to do session 7 in the lab or by telephone. If you choose to do session 7 by phone, we 
will provide you with a safe and cost-free way to mail in your equipment and your saliva sample. You 
DUHS IRB
IRB NUMBER: Pro00062101
IRB APPROVAL DATE: 09/11/2018
IRB EXPIRATION DATE: 09/23/2019


 
 
 
 
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Mobile Contingency Management for Concurrent  
Abstinence from Alcohol and Smoking (Stage 2) 
 
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will be paid $50 for participating in the assessments in session 7, and $50 for providing a saliva sample. 
You will be paid $35 for returning the study equipment.  
 
Session 8: This session occurs 6 months after your quit date (session 4). In this session, you will 
complete some questionnaires about your smoking and alcohol use. We will ask you to provide a saliva 
(spit) sample. We will pay you $50 for participating in this session, $50 for providing the saliva sample, 
and $50 for providing a blood sample by finger prick for a dried blood spot test. 
 
The investigational parts of this study are the questionnaires that we ask you to complete, the home 
monitoring and uploading of videos, and the payments for not smoking and/or not drinking alcohol. If 
you were to go to a doctor for help in stopping smoking, you might not be asked to do those parts.  
 
HOW LONG WILL I BE IN THIS STUDY? 
Your active participation in this study will last about eight weeks. You will have a follow-up session six 
months after your quit date. Altogether, your participation will last about 7 ½ months. You can choose 
to stop participating at any time without penalty or loss of any benefits to which you are entitled. 
However, if you decide to stop participating in the study, we encourage you to talk to your doctor first. 
 
Clinically relevant results of this research will be communicated with you. 
 
WHAT ARE THE RISKS OF THE STUDY? 
As a result of your participation in this study, you are at risk for the following side effects. You should 
discuss these with the study doctor and your regular health care provider if you choose. 
 
Stopping smoking causes withdrawal symptoms. Symptoms can last for a few days to several weeks. 
These may include: headaches, dizziness, nausea, anxious or depressed mood, feelings of frustration and 
anger, trouble sleeping, bad dreams, trouble concentrating, restlessness, tiredness, increased appetite, 
weight gain, and craving for cigarettes.  
 
Stopping alcohol use may cause withdrawal symptoms. Symptoms of alcohol withdrawal may include 
headache, insomnia, sweating, shakiness, and rarely, seizures or hallucinations.  
 
There are no known risks associated with completing paper and pencil measures or electronic diary 
entries. There is a possible risk of temporary anxiety associated with discussing psychiatric symptoms.  
There is a potential risk for loss of confidentiality associated with using the mobile application(s).  
 
Using nicotine in the form of patches, gum, inhaler, or lozenge may cause some, all, or none of the side 
effects listed below.  
More likely  
 acid or sour stomach 
 belching 
DUHS IRB
IRB NUMBER: Pro00062101
IRB APPROVAL DATE: 09/11/2018
IRB EXPIRATION DATE: 09/23/2019


 
 
 
 
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Mobile Contingency Management for Concurrent  
Abstinence from Alcohol and Smoking (Stage 2) 
 
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 coughing 
 heartburn 
 indigestion 
 mouth and throat irritation 
 stomach discomfort, upset, or pain 
 stuffy nose 
Less likely: 
 anxiety 
 back pain 
 change in taste 
 diarrhea 
 dizziness 
 feeling of burning, numbness, tightness, tingling, warmth, or heat 
 flu-like symptoms 
 general pain 
 hiccups 
 mental depression 
 pain in the jaw and neck 
 pain in the muscles 
 passing of gas 
 problems with teeth 
 trouble with sleeping 
 unusual tiredness or weakness 
 fast or irregular heartbeat 
 fever with or without chills 
 headache 
 nausea with or without vomiting 
 runny nose 
 shortness of breath 
 tightness in the chest, trouble with breathing, or wheezing 
 skin rash, itching, or hives 
 tearing of the eyes 
 
Nicotine patches may cause skin irritation, increased heart rate, nightmares, and increased blood 
pressure. Nicotine gum and lozenges may cause a tingling or burning sensation in the mouth. Nicotine 
inhaler doesn’t have any additional risks.  
 
Bupropion may cause some, all or none of the side-effects listed below. 
More likely  
DUHS IRB
IRB NUMBER: Pro00062101
IRB APPROVAL DATE: 09/11/2018
IRB EXPIRATION DATE: 09/23/2019


 
 
 
 
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Mobile Contingency Management for Concurrent  
Abstinence from Alcohol and Smoking (Stage 2) 
 
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 dry mouth 
 trouble sleeping 
 nausea 
 constipation 
 headache 
 shakiness or jitteriness 
 skin rash 
 sweating  
 change in appetite 
 weight loss 
 dizziness 
 tremor 
 hot flashes 
 ringing in the ears 
Less Likely  
 unusual fatigue 
 diarrhea or abdominal pain 
 muscle or joint aches that last days 
 yellowing of your skin 
 seizures  
 thinking abnormally  
 
The Food and Drug Administration (FDA) has recommended that individuals taking certain medications 
including bupropion SR should watch out for worsening depression, or suicidal thoughts and behavior. 
You should also watch for sudden and severe changes in feelings such as: anxiety, agitation, feelings of 
panic, irritability, hostility, aggressiveness, impulsivity, severe restlessness, feeling overly excited or 
hyperactive, or not being able to sleep. In addition, you should tell family members or caregivers to 
watch out for these symptoms while you are taking the medicine. If you, your family members, or your 
caregivers notice any of these symptoms, you should notify the study doctor as soon as possible. If you 
are having suicidal thoughts or behaviors, you should go the nearest hospital emergency room.  
 
You should avoid driving a car or operating heavy machinery until you know how the medications affect 
you. 
 
If you are a female: Being a part of this study while pregnant may expose the unborn child to 
significant risks, some of which may be currently unforeseeable. Therefore, pregnant women will be 
excluded from the study. If you are a woman of childbearing potential, a urine pregnancy test will be 
done, and it must be negative before you can continue in this study. If sexually active, you must agree to 
use appropriate contraceptive measures for the duration of the study. Medically acceptable 
contraceptives include: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved 
DUHS IRB
IRB NUMBER: Pro00062101
IRB APPROVAL DATE: 09/11/2018
IRB EXPIRATION DATE: 09/23/2019


 
 
 
 
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Mobile Contingency Management for Concurrent  
Abstinence from Alcohol and Smoking (Stage 2) 
 
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hormonal contraceptives (such as birth control pills (if you are under 35 years of age), patches, implants 
or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an 
intrauterine device (IUD). Contraceptive measures such as Plan B (TM), sold for emergency use after 
unprotected sex, are not acceptable methods for routine use. If you do become pregnant during this study 
or if you have unprotected sex, you must inform your study physician immediately. 
 
Drug and Food Interactions: For your safety, you must tell the study doctor or nurse about all the 
prescribed medical foods and drugs, herbal products, over-the-counter (OTC) drugs, vitamins, natural 
remedies, and alcohol that you are taking before you start the study and before starting to take any of 
these products while you are on the study. Bupropion may increase the risk of likelihood of seizures, 
especially if you are drinking while taking it. If you begin drinking more frequently than you 
reported in your first session, please notify the study coordinator. It is important for us to know this 
so that we can help protect you from the health risks of drinking and taking the medications. If at any 
point we believe that your alcohol use might be a health risk because of the medications, we will 
withdraw you from the study or ask you to quit taking the medication(s) that can cause this health risk. 
 
Blood Spot Collection: At the 6-month follow-up, you will be asked to provide a blood sample to assess 
drinking status. Blood will be taken from your index, middle, or ring finger with a very simple prick to 
your finger, collecting about 3mL of blood. The risks of having a blood puncture includes temporary 
pain for the needle stick, bruising, and rarely, infection. Some people may experience dizziness, possibly 
lightheadedness, or rarely, fainting. Should any of these symptoms occur, the collection process will 
stop and the collector will follow health and safety protocols as required. 
 
There may be risks, discomforts, drug interactions, or side effects that are not yet known.  
 
ARE THERE BENEFITS TO TAKING PART IN THE STUDY? 
If you agree to take part in this study, there may be direct medical benefit to you. You may benefit from 
stopping smoking and drinking alcohol. However, we cannot guarantee that you will stop smoking or 
drinking during this study.  We hope that in the future the information learned from this study will 
benefit other people who are trying to stop smoking and/or drinking.   
 
WHAT ALTERNATIVES ARE THERE TO PARTICIPATION IN THIS STUDY? 
Instead of being in this study, you could enroll in another smoking and/or drinking cessation treatment 
program. There may be other treatment programs available to you in the community. Please talk to your 
doctor about these and perhaps other options. 
 
WILL MY INFORMATION BE KEPT CONFIDENTIAL? 
Participation in research involves some loss of privacy. We will do our best to make sure that 
information about you is kept confidential, but we cannot guarantee total confidentiality. Your personal 
information may be viewed by individuals involved in this research and may be seen by people 
including those collaborating, funding, and regulating the study. We will share only the minimum 
DUHS IRB
IRB NUMBER: Pro00062101
IRB APPROVAL DATE: 09/11/2018
IRB EXPIRATION DATE: 09/23/2019


 
 
 
 
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Mobile Contingency Management for Concurrent  
Abstinence from Alcohol and Smoking (Stage 2) 
 
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necessary information in order to conduct the research. Your personal information may also be given out 
if required by law.  
 
As part of the study, your records may be reviewed in order to meet federal or state regulations. 
Reviewers may include representatives from the Duke University Health System Institutional Review 
Board, National Institutes of Health, the Office for Human Research Protections, and/or the Food and 
Drug Administration, and others as appropriate. If any of these groups review your research record, they 
may also need to review your entire medical record. 
 
The mCM mobile application will upload the videos you take to InMotion Hosting, Inc. The data may 
be permanently kept by this group and/or their contracting partners. The mobile application was 
developed by a study staff member who is our partner at the Durham, NC Department of Veterans 
Affairs Medical Center.  
 
If you are loaned a Duke phone for use during this study and you use it for non-study related reasons, 
this could add your personal information onto the device and potentially result in it being sent to 
unauthorized persons. The device will be preset with security settings. Please do not alter these during 
the course of the study. We will limit some of the phone functions, like internet searching and emailing. 
You should not attempt to re-install those functions. You should not use the phone for personal use, for 
example, personal phone calls or taking pictures during the study. If you do so, this could add your 
personal information onto the phone and potentially result in it being sent to unauthorized persons. You 
are encouraged to limit personal identifiers you enter into mobile applications (particularly your name, 
date of birth, address, place of employment, and other details that could allow someone to identify you) 
only to those that you wish to voluntarily share with others. When you return the device at the end of the 
study, the device will be cleaned to remove any of your personal information.  If the device is lost or 
stolen during the course of the study, please contact the study team immediately.  
 
We are not asking you to make any health decisions based on the use of these mobile apps. You should 
discuss health decisions directly with your healthcare provider.    
 
As with all technology, we ask you to wait until you are in a safe environment, use good judgment and 
follow prevailing laws.  Do not perform study-related activities while you are driving.  
 
All of the urine and saliva, and blood sample studies are being done only because you are in this study.  
The study results will not be given to you to send OR sent to your physician to include in your medical 
record. 
 
The Department of Health and Human Services (HHS) has issued a Certificate of Confidentiality to 
further protect your privacy.  With this Certificate, the investigators may not disclose research 
information that may identify you in any Federal, State, or local civil, criminal, administrative, 
DUHS IRB
IRB NUMBER: Pro00062101
IRB APPROVAL DATE: 09/11/2018
IRB EXPIRATION DATE: 09/23/2019


 
 
 
 
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Mobile Contingency Management for Concurrent  
Abstinence from Alcohol and Smoking (Stage 2) 
 
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legislative, or other proceedings, unless you have consented for this use. Research information protected 
by this Certificate cannot be disclosed to anyone else who is not connected with the research unless:   
1) there is a law that requires disclosure (such as to report child abuse or communicable 
diseases but not for legal proceedings);  
2) you have consented to the disclosure, including for your medical treatment; or  
3) the research information is used for other scientific research, as allowed by federal 
regulations protecting research subjects.  
 
Disclosure is required, however, for audit or program evaluation requested by the agency that is funding 
this project or for information that is required by the Food and Drug Administration (FDA). 
  
You should understand that a Confidentiality Certificate does not prevent you or a member of your 
family from voluntarily releasing information about yourself or your involvement in this research. If you 
want your research information released to an insurer, medical care provider, or any other person not 
connected with the research, you must provide consent to allow the researchers to release it. This means 
that you and your family must also actively protect your own privacy. 
 
Finally, you should understand that the investigator is not prevented from taking steps, including 
reporting to authorities, to prevent serious harm to yourself or others. 
 
The study results will be retained in your research record for at least six years after the study is 
completed. At that time either the research information not already in your medical record may be 
destroyed or information identifying you will be removed from such study results at DUHS.  Any 
research information in your medical record will be kept indefinitely. 
 
This information may be further disclosed by the sponsor of this study.  If disclosed by the sponsor, the 
information is no longer covered by federal privacy regulations. If this information is disclosed to 
outside reviewers for audit purposes, it may be further disclosed by them and may not be covered by 
federal privacy regulations. 
 
While the information and data resulting from this study may be presented at scientific meetings or 
published in a scientific journal, your name or other personal information will not be revealed. 
 
Some people or groups who receive your health information might not have to follow the same privacy 
rules. Once your information is shared outside of DUHS, we cannot guarantee that it will remain private. 
If you decide to share private information with anyone not involved in the study, the federal law 
designed to protect your health information privacy may no longer apply to the information you have 
shared.  Other laws may or may not protect sharing of private health information. 
 
DUHS IRB
IRB NUMBER: Pro00062101
IRB APPROVAL DATE: 09/11/2018
IRB EXPIRATION DATE: 09/23/2019


 
 
 
 
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Mobile Contingency Management for Concurrent  
Abstinence from Alcohol and Smoking (Stage 2) 
 
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Form
M0345
WHAT ARE THE COSTS TO YOU? 
You or your insurance provider will be responsible and billed for all costs related to your routine 
medical care, including copayments and deductibles. Routine medical care services are those that you 
would have received for your condition if you were not participating in this research study. Not all 
services are covered by insurance.  Some procedures or scans may require pre-authorization by your 
insurance plan. We will notify you if we learn that a service is not covered by your insurance plan as 
part of the pre-authorization process. If it is not covered, you will be responsible for paying for it.  The 
amount of your out-of-pocket expense will depend on your insurance plan.  For beneficiaries with 
Medicare Advantage Plans, traditional Medicare is billed for the routine cost of a research study.  You 
may have more or higher co-pays than with a Medicare Advantage plan.  Please discuss the costs of the 
study with Dr. Dedert. At your request, a Financial Counselor in the clinic may provide you with an 
estimate of costs for routine services. 
 
Duke University Medical Center will provide the bupropion, NRT and equipment free of charge for your 
use in this study. At the conclusion of the study, or if you decide to withdraw from the study, you must 
return all unused medications to the study coordinator. Dr. Dedert may request that you return for a 
checkup before you stop your medications if he thinks that stopping them suddenly may harm you. He 
may also ask you to complete the tests that would ordinarily occur when a person completes the study. 
 
WHAT ABOUT COMPENSATION? 
You will be reimbursed up to $250 for your expenses related to your participation (parking, gas, and 
time). You will be compensated $50 for a saliva sample at Session 7.  
 
If you are assigned to the Mobile Contingency Management group, you will also be compensated up to 
$1,136 for at-home monitoring and abstinence from drinking and smoking. Most people do not earn this 
much money for at-home monitoring. This compensation is offered as an incentive for you to stop 
drinking alcohol and stop smoking cigarettes. In total, you will be compensated up to $1471 for 
participation, depending on how many prompts you receive to complete Breathalyzer readings and how 
well you do in completing readings and stopping your substance use.. If you are assigned to the Mobile 
Monitoring group, you will also be compensated up to approximately $589 for at-home monitoring 
regardless of whether you stop drinking alcohol and smoking cigarettes. These numbers may vary 
slightly due to variations in the possible number of alcohol alarms. If you do not complete the study, you 
will be given partial compensation for those parts you have completed.  
 
Payment will be given to you in several installments. Payment will be requested for session 1 just after 
you have completed it. Payments during monitoring will be requested as frequently as weekly and 
payment for session 8 will be requested just after you have completed it. After we request payment, it 
may take up to four to six weeks for you to receive payment.  
 
Payment received as compensation for participation in research is considered taxable income to the 
research subject. If payment to an individual exceeds $600 in any one calendar year, Duke University is 
DUHS IRB
IRB NUMBER: Pro00062101
IRB APPROVAL DATE: 09/11/2018
IRB EXPIRATION DATE: 09/23/2019


 
 
 
 
Consent to Participate in a Research Study 
Mobile Contingency Management for Concurrent  
Abstinence from Alcohol and Smoking (Stage 2) 
 
Page 14 of 15 
Subject*Initials_________
DUKE UNIVERSITY HEALTH SYSTEM
Form
M0345
required to report this information to the Internal Revenue Service (IRS). Research subject payments to 
a non-employee of Duke University exceeding $600 during any calendar year will result in a 1099 
(Miscellaneous Income) form being issued to the individual and a copy sent to the IRS. 
 
WHAT ABOUT RESEARCH RELATED INJURIES? 
Immediate necessary medical care is available at Duke University Medical Center in the event that you 
are injured as a result of your participation in this research study. However, there is no commitment by 
Duke University, Duke University Health System, Inc., or your Duke physicians to provide monetary 
compensation or free medical care to you in the event of a study-related injury. 
 
For questions about the study or research-related injury, contact Dr. Dedert at 919-384-8582, ext. 4055 
during regular business hours and at 919-286-0411 and ask the operator to contact Dr.  Dedert at home 
after hours and on weekends and holidays. 
 
WHAT ABOUT MY RIGHTS TO DECLINE PARTICIPATION OR WITHDRAW FROM THE 
STUDY? 
You may choose not to be in the study, or, if you agree to be in the study, you may withdraw from the 
study at any time. If you withdraw from the study, no new data about you will be collected for study 
purposes unless the data concern an adverse event (a bad effect) related to the study. If such an adverse 
event occurs, we may need to review your entire medical record.   
 
Your decision not to participate or to withdraw from the study will not involve any penalty or loss of 
benefits to which you are entitled, and will not affect your access to health care at Duke. If you do 
decide to withdraw, we ask that you contact Dr. Dedert in writing and let him know that you are 
withdrawing from the study. His mailing address is Eric Dedert, Ph.D., Duke University Medical Center, 
Box 2969, Durham, NC 27705. You will be asked to return any study equipment you have been loaned.  
 
We will tell you about new information that may affect your health, welfare, or willingness to stay in 
this study. 
 
Your doctor may decide to take you off this study if your condition gets worse, if you have serious side 
effects, or if your study doctor determines that it is no longer in your best interest to continue. Reasons 
why this might occur include failure to follow the instructions of the study staff, inability to complete 
the study requirements, or inability to attend study visits as scheduled. If this occurs, you will be notified 
and your study doctor will discuss other options with you. 
 
Your data may be stored and shared for future research without additional informed consent if 
identifiable private information, such as your name and medical record number, are removed. If your 
identifying information is removed from your samples or data, we will no longer be able to identify and 
destroy them. 
 
DUHS IRB
IRB NUMBER: Pro00062101
IRB APPROVAL DATE: 09/11/2018
IRB EXPIRATION DATE: 09/23/2019


 
 
 
 
Consent to Participate in a Research Study 
Mobile Contingency Management for Concurrent  
Abstinence from Alcohol and Smoking (Stage 2) 
 
Page 15 of 15 
*
DUKE UNIVERSITY HEALTH SYSTEM
Form
M0345
A description of this clinical trial will be available on https://clinicaltrials.gov/  as required by U.S. Law.  
This Web site will not include information that can identify you.  At most, the Web site will include a 
summary of the results.  You can search this Web site at any time. 
 
WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS? 
For questions about the study or a research-related injury, or if you have problems, concerns, questions 
or suggestions about the research, contact Dr. Dedert at 919-684-9022 or 919-384-8582 x4055 during 
regular business hours, or toll free at 1-888-878-6890 and ask the operator to contact Dr. Dedert at home 
after hours and on weekends and holidays. You may also contact Dr. Scott Moore at 919-286-0411, ext. 
7695, or toll free at 1-888-878-6890 and ask the operator to contact Dr. Moore at home after hours and 
on weekends and holidays. 
 
For questions about your rights as a research participant, or to discuss problems, concerns or suggestions 
related to the research, or to obtain information or offer input about the research, contact the Duke 
University Health System Institutional Review Board (IRB) Office at (919) 668-5111. 
 
STATEMENT OF CONSENT 
"The purpose of this study, procedures to be followed, risks and benefits have been explained to me. I 
have been allowed to ask questions, and my questions have been answered to my satisfaction. I have 
been told whom to contact if I have questions, to discuss problems, concerns, or suggestions related to 
the research, or to obtain information or offer input about the research. I have read this consent form and 
agree to be in this study, with the understanding that I may withdraw at any time.  I have been told that I 
will be given a signed and dated copy of this consent form." 
 
__________________________________________ 
 
___________     ____________ 
Signature of Subject  
 
 
 
 
 
Date 
 
   Time 
 
__________________________________________ 
 
___________     ____________ 
Signature of Person Obtaining Consent 
 
 
 
Date 
 
   Time 
DUHS IRB
IRB NUMBER: Pro00062101
IRB APPROVAL DATE: 09/11/2018
IRB EXPIRATION DATE: 09/23/2019