A Brief Behavioral Intervention for Co-users of Marijuana (MJ) and Tobacco Among Smokers Calling State Quitlines
Phase: NA
Conditions: Smoking Cessation, Marijuana Use
Sponsor: Consumer Wellness Solutions

Study Title:  Project CheckUP: A Brief Behavioral Intervention for Quitline Callers Who Use 
Marijuana (MJ) and Tobacco 
NCT #: NCT04737772 
Document Date: 04/19/2024 (Finalized and Uploaded) 

1. RESEARCH OVERVIEW / ABSTRACT (LIMIT 500 CHARACTERS)
There is an urgent need to engage co-users of tobacco and cannabis (CB) in evidence-based 
treatments that lead to better cessation outcomes. A significant number of cigarette smokers 
who call state quitlines (QL) for help quitting tobacco report using cannabis and are interested in 
reducing or quitting cannabis. Adding a brief intervention to address cannabis simultaneously  
with standard tobacco cessation counseling may lead to improved tobacco cessation outcomes 
and reduce cannabis use.  
Protocol Number 
Info Ed 2020-0017 
Principal 
Investigator 
Kelly Carpenter, PhD 
Title 
(Please include 
Initiative# as prefix) 
[INI 2020-0017] Project Check-up: A brief behavioral intervention for co-users 
of marijuana (MJ) and tobacco for smokers calling state quitlines (“Project 
Check-up”) 
Type of Research 
Description 
Interventional Research 
Funding Sponsor 
National Institutes of Health, National Institute on Drug Abuse 
Device Vendor 
(if applicable) 
N/A 
UHG Research Sites 
Conducted remotely via phone by Optum Consumer Wellness Solution’s Quit For 
Life (Tobacco Quitline) Product and Optum Center for Wellbeing Research  
In 2023 Consumer Wellness Solutions became part of RVO Health and the 
Center for Wellbeing Research is no longer affiliated with Optum. RVO Health 
now operates the Quit for Life (Tobacco Quitline) product and the Center for 
Wellbeing Research. 
External 
Sites/Partners 
(if applicable) 
Denise Walker, PhD (University of Washington, School of Social Work) 
Beatriz Carlini, PhD (University of Washington, Alcohol and Drug Abuse 
Institute) 
Harold Javitz, PhD Independent consultant (previously SRI International) 
Maryland Marketing Source  
Sub-Investigators 
Denise Walker, PhD (University of Washington, School of Social Work) 
Beatriz Carlini, PhD (University of Washington, Alcohol and Drug Abuse 
Institute) 
Protocol Document 
Version & Date 
PCU_Protocol_V8 

2. STUDY PURPOSE & OBJECTIVES
Our specific aims are to: 
1) Develop an integrated tobacco/cannabis (CB) intervention utilizing key components
of the Marijuana Check-up (MJCU, a brief behavioral intervention for increasing
motivation to reduce or quit using cannabis). We will adapt the MJCU intervention for
integration into tobacco cessation counseling; develop the intervention manual and training
materials, and pilot test the new treatment with 10 QL callers who use CB. Our team
includes an author of the MJCU, Dr. Denise Walker at the University of Washington who will
assist with development, training, and implementation of the integrated intervention.
2) Conduct a small, randomized pilot trial of the integrated intervention compared with
the standard QL (treatment as usual; TAU) to evaluate feasibility, acceptability, and
preliminary effectiveness with 100 co-users recruited from 4 participating state QLs. We will
assess implementation factors, coach fidelity, treatment engagement, and outcomes at 3
months (satisfaction, tobacco cessation (biochemically verified), and CB use).
We hypothesize that the intervention will: (1) be feasible to deliver (measured by coach 
treatment fidelity scores); (2) be acceptable to co-users (measured by enrollments and call 
completion numbers); (3) increase tobacco cessation rates compared with TAU; (4) increase co-
users' motivation to change CB use; and (5) will produce greater reduction or cessation of CB.  
Significance: This study comes at a critical time to answer key questions posed by state and 
local health departments who are considering the best methods for reaching CB users and 
increasing treatment utilization. Nationally, QLs have expressed concerns about the potential 
growth of co-users calling quitlines and the need to address the impact this has on treatment 
outcomes.  
Public Health Relevance: Smoking cigarettes remains the number one preventable cause of 
death and disease in the US. Smokers who call QLs and use cannabis may struggle to quit due 
to the interactive effects of nicotine and CB. The proposed brief behavioral intervention 
addressing co-use may increase QL callers’ chances of achieving and maintaining tobacco 
abstinence as well as increase their motivation to reduce CB use. As non-medicinal CB use 
becomes more common and legal in more states, a low touch intervention for co-users of CB 
and tobacco could improve health outcomes for many. Findings will inform development of 
scalable public health intervention strategies for co-users easily implemented across QLs. 
3. JUSTIFICATION & BACKGROUND
 Background and Significance 
Tobacco use remains the number one preventable cause of illness and death in the US. 
Targeted therapies are needed for priority populations. Tobacco use causes more than 480,000 
deaths each year and for each of those deaths there are 30 people living with serious smoking-
related illnesses. [1] Tobacco use also costs the US economy an estimated $300 billion from 
health care costs and lost productivity. While smoking rates in recent years have dramatically 
decreased in the general population, they have remained almost unchanged in people with 
mental health conditions, including substance use disorders [2]. 

Cannabis (CB), is the most common illicit substance used today, but is increasingly becoming 
legal [4]. As of 2018, thirty-three states and the District of Columbia (DC) have legalized CB in 
some form and 10 states and DC have legalized non-medical CB use (Alaska, California, 
Colorado, Maine, Massachusetts, Michigan, Nevada, Oregon, Vermont, and Washington). 
According to a 2017 survey, 14.6% of US adults used MJ in the past year, 8.7% in the past 30 
days [5]. Use appears higher in states with legalized non-medical CB (20%) than in states with 
only legalized medical CB (14%) or no legal use (12%) and inversely correlated with age, with 
younger adults using at higher rates than older adults. [5]  
Co-users of tobacco and CB have more difficulty quitting either substance and are at higher risk 
for tobacco-related illnesses. Recent longitudinal research shows that MJ users are more likely 
to start smoking cigarettes, continue to smoke over time (as opposed to quitting), and to relapse 
once quit. [18] Indeed, daily use of CB is associated with a 3.6 fold increase in nicotine 
dependence. [19, 20] Furthermore, nicotine is far more addictive than CB, works on the same 
neural pathways as CB [21], and cross-sensitization to each substance is likely to occur, with 
tobacco directly enhancing the subjective effect of CB, [12, 22, 23] leaving co-users more likely 
to develop a cannabis use disorder. [24]  
Optum is the service provider for publicly funded tobacco cessation QL in 20 states and for 
more than 750 commercial clients with their Quit For Life coaching program. QLs are the 
primary method of accessing tobacco cessation services in the US and offer free services to 
any US resident. QL services include phone coaching, nicotine replacement medications (e.g., 
the nicotine patch), and digital services such as text messaging, a web intervention and a 
mobile app. 
Co-users of tobacco and CB are at risk for continued tobacco dependence and associated 
serious health consequences of using both substances. CB use hinders smoking cessation 
efforts and tobacco use is a predictor of poor outcomes of CB dependence treatment. Our 
understanding of what is effective to reach and help co-users quit tobacco and CB is limited. 
Within this gap of knowledge is whether co-users who call tobacco cessation quitlines for help 
with cessation would benefit from an integrated phone-based program with CB elements based 
on the Marijuana Check-up (MJCU), the most widely used intervention for CB. Accordingly, we 
propose to develop and test a brief phone-based intervention for co-users of tobacco and CB for 
delivery in a quitline setting.  
4. STUDY DESIGN
1. Design
D.4. Phase 2: Preliminary effectiveness pilot randomized controlled trial.
Overview. QL registration agents, coaches and/or research staff at Optum will screen for CB
use and other study eligibility criteria and enroll participants into their respective state quitline.
Once confirmed eligible, consented participants will complete the baseline assessment and be
randomized into standard QL treatment as usual (TAU) or the experimental treatment, QL-
CBCU. Approximately 3 months after randomization, we will email participants a link to the
follow-up survey (with instructions). For those who fail to complete the online survey after two
emails,  we will send participant contact information via a secure transmission protocol to an
external survey group who will attempt to complete the survey by phone, making 11 attempts at

different times of day and on different days. Those who do not complete the interview within 14 
days will be emailed a reminder to take the full online survey or an optional brief online survey. 
Our research team will monitor completed surveys to identify those who reported they had not 
smoked tobacco in the past 7 days and request a biochemical validation test from participants 
as explained below (See section D.8.2. Biochemical Validation).  
D.4.1. Setting. Participants will primarily be recruited from incoming callers from four state
tobacco QLs with fully legalized CB use (Alaska, Washington DC, Oregon, Washington). See
letters of support. These four QLs offer four or five proactive coaching calls, mailed support
materials, access to text messaging, and web-based programs, plus at least two weeks of free
NRT. If recruitment rates are slow, an alternative strategy of recruiting from social media (e.g.,
Reddit) will be implemented. All eligibility criteria will remain the same.
There will be two behavioral interventions tested in this trial; the standard quitline (treatment as 
usual: TAU) and the standard QL plus an adapted version of the CBCU (QL-CBCU). Both are 
phone based, brief, and utilize similar behavior change techniques: motivational interviewing 
(MI) and cognitive behavioral therapy (CBT). Both interventions include 4-5 proactive counseling
calls, mailed materials, and at least 2 weeks of NRT. The new QL-CBCU intervention is being
designed to be integrated into the quitline setting and delivered by quitline coaches with minimal
training and infrastructure adaptation.
1. Duration
Participation will take about 3 months. The entire duration of the study is approximately 3 years. 
2. Metrics and Variables
Table 2. Self-Report Measures 
Screen 
Baseline 
3-month follow-up
Demographics 
X 
X 
Chronic Conditions and Health Problems 
X 
Mental Health (PhQ2, GAD, PSS) 
X 
Alcohol Use 
X 
TO & E-Cigarette Use 
X 
X 
X 
Motivation for Quitting TO 
X 
Cessation Medication use 
X 
CB Use 
X 
Marijuana Problem List (MPL) & CUDIT 
X 
X 
Motivation for Quitting/Reducing CB Use 
X 
X 
CB Quit Goals and Impact on TO Use 
X 
X 
Outcomes 
Program satisfaction and acceptability (usefulness, 
would recommend the program to others) 
X 
7- and 30-day point prevalence tobacco
abstinence
X 
Cannabis use (days/ week; occasions/day; hours 
of intoxication) 
X 
X 

3. Data
The sources of research materials obtained from individual human subjects in the
study are limited to records and data, which will be available to the study team.
Records include number and duration of counseling calls automatically collected by
Optum. Data will be in the form of self-report questionnaires collected on the phone
or via the internet and stored in a secure computer assisted telephone interview
(CATI) system or via a secure link to a survey collection database. The 3-month
follow-up survey may be completed via an online secure survey sent by Optum or
telephone survey conducted by an external survey team. For participants who do not
respond to the online or phone surveys, the research team will email participants a
reminder to complete the full online survey or an brief online survey. There will also
be biochemical verification of tobacco use at 3 months post randomization.
4. Materials
Emailed and mailed letters
An emailed outcomes survey
Saliva test kit
5. Devices – N/A
5. STUDY POPULATIONS
1. Target Population
Quitline callers from participating states who are current smokers interested in quitting smoking 
cigarettes who also indicated that they use marijuana. 
2. Number of Subjects
We will conduct a small randomized controlled study of the new intervention with 100 (up to 
230) co-users recruited from the four state quitlines (AK, DC, OR, WA).
3. Eligibility
Eligibility criteria: Inclusion criteria: study participants will be daily tobacco smokers who smoke 
5 or more cigarettes per day (CPD), aged 21 and older that are recruited from participating state 
QLs (or social media sites), screen positive for current use of CB, screen negative for serious 
mental illness (schizophrenia), and provide an email address (to receive study communications 
and links to the follow-up (2/3 month) survey). Other eligibility criteria include wanting to quit 
tobacco in the next 30 days and use of CB on 9 or more of the past 30 days. Exclusion criteria 
include being unable to speak and read English, limited access to a telephone, use of cannabis 
in the past 12 months was recommended by a doctor or other health care professional, and 
those who do not have another member of their household enrolled in the study. Pregnant or 
post-partum women are also excluded because they are offered a tailored QL protocol that 
differs from the standard call program).  
4. Potentially Vulnerable Populations – [N/A]
5. Subject Identification & Accrual Plan (OR Plan for obtaining data and/or bio
specimens if subjects are not directly enrolled)
Participants will be recruited from incoming callers to participating state quitlines or 
recruited from ads on social media sites (e.g., Reddit) and enrolled into the quitline. 
State quitlines have given their permission for us to recruit from their callers and to 

recruit from external sites if needed. All research personnel have experience working 
with quitline callers and smokers. Drs. Walker and Carlini have experience working 
with smokers who also use cannabis.  
6. Recruitment Plan and Materials
Recruitment 
Recruitment for the study will have two methods. The primary method begins by screening for 
CB use during enrollment with the quitline and assessing eligibility and interest in the study. 
Optum’s computer system will provide initial pre-screening so that only callers from participating 
quitlines who are 21+ years old are screened for the study. Registration agents will ask 
additional screening questions including CB use for at least 9 days in the last 30, interest in 
quitting smoking within 30 days, ready access to phone and email, screen negative for serious 
mental illness (schizophrenia), and whether they have an interest in study participation. The 
secondary recruitment method will be recruiting from ads on location specific social media sites 
(e.g., the r/Washington site on Reddit). Interested participants will email the study research 
assistant who will screen participants over the phone and enroll them into their respective state 
quitline if eligible. All participants will be contacted by phone by research-trained coaches who 
will describe the study in more detail, obtain informed consent, and deliver the baseline 
assessment and the post-randomization script. 
Additionally, after the baseline assessment participants will be randomly assigned to receive the 
standard QL intervention (TAU) or the integrated intervention (QL-CBCU). All participants will 
receive the follow-up assessment (outcomes) survey at 3 months.  
7. Enrollment / Consent Plan and Materials
Research-trained coaches will describe the study in more detail, read the information/consent 
document verbatims- and obtain verbal informed consent.  
8. Compensation/Remuneration/Reimbursement
Incentives 
Participants will receive $30 after completing call 1 (for the baseline assessment and call 1 
participation), $20 for completing the second coaching call, $50 for completing the follow-up 
survey or $25 for a partially completed follow-up survey or a brief survey in lieu of the full follow-
up survey, and $20 for completing the biochemical validation test. Participants will also have an 
option to complete the online survey within 48 hours of the email informing them to complete the 
survey for an additional $25 bonus. These incentives will be provided to all participants and both 
study groups (TAU and QL-CBCU). A randomly selected group of participants in the 
experimental group will be invited to complete a post intervention interview with the PI or the 
Co-I and receive $25 upon completion.  
6. STUDY PROCEDURES
1. Procedures

Quitline registration agents at Optum will screen incoming callers from participating QLs for CB 
use and other study eligibility criteria or the study research assistant will screen interested 
participants recruited from social media ads. Specially trained QL (RIU Check-UP) coaches 
deliver the informed consent script. They complete the baseline assessment over the phone 
with participants who give their verbal consent to participate in the study. Participants are 
randomized to the standard QL treatment as usual (TAU) or the experimental treatment (QL-
CBCU), which is provided by the RIU Check-UP coaches.  
 
We will email participants a link to the follow-up survey (with instructions) at 3 months post 
enrollment. For those who do not complete the online survey after two emails, we will send 
participant contact information via a secure transmission protocol to an external survey group, 
Maryland Marketing Source (MMS; blind to study condition) who will attempt to complete the 
survey by phone, making up to 11 attempts at different times of day and on different days. 
Those who do not complete the interview within 14 days may be emailed a reminder to 
complete the full online follow-up survey or an optional brief survey in lieu of the full follow-up 
survey. Our research team will monitor completed surveys to identify those who reported they 
had not smoked tobacco in the past 7 days and request a biochemical validation test from 
participants as explained below. Selected participants will be contacted after completing the 
follow-up survey for an interview via Microsoft Teams or Zoom about their experience with the 
intervention. Participants will be provided with the link and dial in number for Teams or Zoom to 
access the interview and be notified the call may be recorded or transcribed. If the participant 
objects to a Zoom or Teams interview, they may be offered a phone interview as an alternative. 
If a participant engages in inappropriate or abusive behavior towards the study team, they may 
be terminated from the study by the Principal Investigator. 
 
Biochemical verification:  
Participants self-reporting tobacco abstinence 7 or more days at follow-up will be sent a test to 
confirm their abstinence by biochemical verification (saliva).  Before sending the biochemical 
verification kit, study staff may contact the participant via email with an alert that a biochemical 
verification kit with instructions will be mailed to them and can be tracked with the provided 
USPS tracking number. A cover letter will be included in the kit explaining how to complete the 
test, instructions for returning the results via a photo to the study team’s email box, and 14 day 
requested timeline for submitting the results.  Instructions in the kit will inform participants to not 
eat or drink 10 minutes prior to taking the saliva test.  Participants will be directed to refrain from 
including any PII in this email. If the results are not received within 7 days of delivery, a follow 
up email reminder may be sent. If the test outcome is returned by the participant, study staff will 
send the participant a $20 gift card for their participation (regardless of test outcome).  
 
2. Subject Participation  
 
Participant experience in the study:  
 
 
Day 1. 
 
SCREENING- Participant will answer questions if interested in study participation. 

- 
INFORMED CONSENT – If interested and eligible, participant will hear the consent form 
read to them by the Quit Coach. The participant may ask questions before giving their 
consent. The Quit Coach will note the participant has provided their verbal informed 
consent. The participant will be mailed a copy of the consent.  
- 
BASELINE SURVEY – Participant will spend approximately 20 minutes answering 
baseline assessment questions.  
- 
FIRST COACHING CALL – Participant will engage in coaching call about quitting 
smoking with some discussion of how cannabis use will affect their quit attempt. 
Afterwards they will be sent a gift card for $30.  
- 
EMAIL PFR Participant will be sent a feedback report based on their answers to the 
assessment questionnaire. 
- 
COACHING CALL 2 – Participant will be contacted by phone second coaching call 
which will focus on interaction of tobacco and cannabis and the feedback report. 
Participant will be paid $20 following this call. 
FOLLOW UP COACHING CALLS. Participants will be contacted for 2-3 more calls to discuss 
how their smoking quit is going and follow up on cannabis use and goals.  2/3 months following 
enrollment: 
- 
Survey: Participant will be emailed follow up survey which will take about 5 minutes for 
the brief and 20-30 minutes for the full to complete online. If participant does not 
complete online, a phone survey company will call and deliver the survey by phone. If 
not reached by phone, participants may be mailed a reminder to complete the full online 
survey or a brief online survey. Participants will receive a $50 gift card for completing the 
full survey or $25 for a partially completed full survey or the brief survey. If participants 
complete the outcomes survey within 48 hours of the email sent informing them about 
the survey, they will receive an additional $25 bonus for completion.  
- 
Biochemical Verification: If participant reports being quit from tobacco at follow up, a 
saliva test will be sent for confirmation. Participants will receive a small package 
containing all materials and instructions. After completing the test, they will take a picture 
of the test strip and send to the study team via email. They will receive a $20 gift card for 
completing the test and sending a picture within 14 days 
- 
Interview: Selected participants may agree to a phone interview. The research team will 
call selected participants to schedule an interview via Teams or Zoom. Questions will 
concern the participants experience and opinions about the intervention. This will take 
less than an hour, and they will receive a $25 gift card for the interview. 
 
Control group only 
Participant experience in the study - the control group participants will receive standard QL 
services and are eligible for the same gift cards but will not receive the marijuana use-
related materials (PFR) or treatment (coaching call content). They will not be invited to 
participate in any qualitative interviews. 
 
3. Participant Engagement & Results  
 
All counseling calls will be attempted at least five times over different days. We will increase 
retention at the 3 month follow up survey by reminding participants during coaching calls, 
notifying participants by email that their survey is due, and offering the survey first via email with 
a link to the online survey. For those who do not complete the online survey, we will have an 
external survey company attempt to reach participants by phone, making 11 attempts to reach 
them on different days and at different times. Finally, if participants have not responded to the 
phone survey, we may email participants a reminder via email containing links to take the full 
online survey or optional brief survey. We may follow up with participants who only partially 

completed the survey online to troubleshoot any issues completing the survey online offer 
opportunity to complete survey by phone. Participants will receive an invitation for a post 
intervention interview with the PI or Co-I and receive $25 upon completion, for a total of up to 
$145 in incentives. Strategies such as these have proven to be effective in our quitline research 
studies resulting in higher recruitment and retention rates. 
  
4. Data Collection 
  
The sources of research materials obtained from individual human subjects in the study are 
limited to records and data, which will be available to the study team. Records include number 
and duration of counseling calls automatically collected by Optum. Data will be in the form of 
self-report questionnaires collected on the phone or via the internet and stored in a secure 
computer assisted telephone interview (CATI) system or via a secure link to a survey collection 
database. The follow-up survey may be completed via an online secure survey sent by Optum 
or telephone survey conducted by an external survey team. There will also be biochemical 
verification of tobacco use at 3 months post randomization. Documentation of verification will be 
provided to the study team by the participant in the form of a de-identified picture of the test 
result.   
 
5. Data Analysis  
  
For the proposed pilot study we plan to use summary statistics (means and proportions) with 
confidence intervals (CIs), and standard errors (SE), and graphical displays (histograms, pie 
charts, Box plots, etc.), as appropriate, to describe participant self-reported demographic 
characteristics, use of tobacco and cannabis, and other tobacco and cannabis variables 
measured at baseline and/or at each coaching call and at 3-months. We will use Fisher’s exact 
tests, t-tests, and Wilcoxon rank sum tests to compare intervention and control groups. 
Comparisons including mean number of calls completed, mean satisfaction ratings, mean 
change in cigarettes per day (CPD), and mean change in days of cannabis use will be 
completed. We also will compare groups on changes over time on other cannabis measures, 
including hazardous cannabis use. We will address the effect of missing values on estimated 
smoking cessation rates using sensitivity analyses for outcome measures: 1) we will analyze 
responders only, and 2) we will impute missing tobacco use as ‘smoking’. 
We will have sufficient power with 100 participants (50 per group) and a 70% response to the 
follow-up interview to detect significant effects of the integrated intervention (vs. standard 
treatment controls) on feasibility and acceptability of the QL-CBCU intervention as measured by 
calls completed and treatment satisfaction at 3 months. This sample size is also sufficient for 
estimating QL-CBCU’s potential impact (compared with the standard quitline) measured at 3 
months on tobacco abstinence and CB outcomes (motivation to reduce days using CB, 
confidence in avoiding CB over-use, decreased problems associated with CB use, and 
decreased frequency of use). The sample sizes for this feasibility study are sufficient for the 
conduct and reporting of stage I pilot studies and were not selected for purposes of detecting 
statistically significant group differences at the alpha .05 level on outcomes. Our sample size is 
sufficient for documenting what power is available. For ordinal measurements that can 
statistically be treated in a similar manner to "continuous" measures (such as the number of QL 
calls completed and days used CB), we have 80% power to detect an effect size of 0.68. For 
proportions, we are powered to detect a difference in proportions of 0.22 to 0.34 (depending on 
the proportions in the two groups). 

 
7. RISKS AND BENEFITS 
  
1. Risks and Risk Mitigation 
STUDY RISKS  
• 
The primary risk of participating in this study is the risk of breach of confidentiality. A 
breach could potentially occur, for example, if an unauthorized individual accesses the 
study’s database records. Data that the participant sends to the study team via email for 
biochemical verification could potentially be intercepted or viewed by others, as this data 
may be transmitted by the participant from an insecure phone or computer. Additionally, 
some participants may experience emotional discomfort that might occur during 
discussion of smoking, cannabis use, and impacts on their own health. Persons who quit 
smoking may experience temporary discomfort associated with nicotine withdrawal 
symptoms such as irritability, mood changes, headaches, trouble sleeping, and cravings 
to smoke.  Similarly, those who use CB daily or nearly daily and choose to reduce their 
CB use may experience temporary discomfort associated with withdrawal such as 
irritability, anxiety, and sleep disturbances. 
• 
Risks of NRT.  These are standard QL protocol and not specific to the study. These 
are detailed by the quit coach during coaching calls, and so are not listed in the 
consent form. As part of standard service offerings from their state or district quitline, 
nicotine replacement therapy (NRT) in the form of the nicotine patch, gum, or lozenge 
will be offered to participants in this trial. The study will follow standard NRT protocols as 
provided through the quitlines. For each participant who opts to use NRT, Optum 
coaches will assess their medical safety to use NRT and then determine the appropriate 
dose according to clinical practice guidelines. Optum will then mail the NRT to the 
participant along with instructions on how to use the medications. The NRT in this trial is 
being used for its FDA-approved purpose and will be offered to all participants, and 
therefore, the effect of NRT is not being evaluated as part of the trial, although use of 
NRT will be assessed at follow-up. As part of standard quitline services, coaches ask 
about possible side-effects of its use during telephone counseling sessions. According to 
the FDA-approved product insert, possible side effects associated with the patch include 
headache, dizziness, lightheadedness, drowsiness, stomach upset, nausea, or flushing 
the first few days as a user adjusts to the medication. The area around the patch may 
become red, itchy, or irritated. Rarely, users may experience breathing difficulties, chest 
pain, irregular heartbeat, nervousness, anxiety, or tremors. Very rarely, a user of the 
patch may experience an allergic reaction such as a rash, itching, swelling, dizziness, or 
trouble breathing. Side effects will be disclosed in the study consent form. Optum 
distributes NRT to 65,000 of its 250,000 callers per year and has established protocols 
for addressing side effects with callers. 
Alternatives to these risks include not participating in the study. 
Protections against Risk 
• 
Protection against breach of confidentiality: security at Optum. Optum’s quitline 
business is a HIPAA-covered entity and complies with all HIPAA regulations regarding 
data security. The Optum offices provide physical and electronic access security, 
automated backup power for the servers, isolated environmental controls, and fault-
warning systems to maintain a stable production environment for their quitline services. 
Servers, storage appliances, and network components are housed in a dedicated server 

room at the corporate headquarters. All electronic and paper records that contain 
identifiable health information are secured and their use is limited to persons with a 
direct business-related need for access to this information. All hardware is handled as if 
it contains protected health information (PHI). Hardware that is no longer used is 
electronically and physically destroyed. The same security standards that apply to 
Optum normal business practices will be used to secure data collected for this study. 
Paper measures will be stored in locked file cabinets.  All Service Delivery and Research 
Staff Members receive biannual Human Subjects training, yearly HIPAA training, sign a 
confidentiality statement, and are required to adhere to confidentiality and security 
policies and procedures. 
• 
Distress due to participation in the study intervention or assessment. It is possible 
that some participants may be upset or embarrassed by participating in the study 
intervention. Consent scripts will advise potential participants about the study 
intervention and their right to terminate participation at any time without risk or penalty. 
Participants are free to refuse to participate in any element of the study or treatment and 
to refuse to answer any question during the assessments. Expert clinicians are available 
to counsel any participant who becomes distressed, including Drs. Carpenter and 
Walker, who are licensed clinical psychologists, and the clinical supervisory team at 
Optum. 
• 
Nicotine and CB withdrawal. Nicotine and CB withdrawal symptoms are temporary and 
balanced by long term improvements in health. NRT can help mitigate nicotine 
withdrawal. Coaches are trained to help participants cope with short-term effects of 
quitting/reducing tobacco and/or adjust their dose of NRT. Study coaches will be 
educated about withdrawal symptoms associated with CB reduction or cessation. 
Although most of these symptoms are similar to nicotine withdrawal, coaches will receive 
additional training on best ways to help CB users cope with symptoms. 
• 
NRT side effects. Participants enrolled in state quitlines have access to nicotine 
replacement therapy (NRT). Before recommending any medication or dosage, a 
participant’s health condition is assessed with a series of screening questions. Coaches 
assess medical safety for NRT use by screening for Use Exclusion (UE) factors. Use 
Exclusions include: diagnoses of heart attack, stroke, or TIA within the past two weeks; 
being told by a health care provider within the past 6 months of a rapid or irregular 
heartbeat that required a change in activities or medication; being told by a health care 
provider in the past 6 months that they have serious or worsening angina; or a previous 
reaction to patch medication or adhesive tape that caused a rash or hives over the body, 
swelling of face or throat, wheezing or shortness of breath, or high fever, or that required 
the participant to discontinue use, or caused irritation that continued after rotating the 
patch and/or using hydrocortisone cream. If a participant is not eligible for NRT due to a 
UE, then a Medical Doctor (MD) Override Letter is sent to the participant. Once Optum 
receives the completed MD Override form from the participants MD and confirms NRT 
dosing with the participant, Optum sends the participant’s NRT shipment.  The screening 
questions were designed by Optum’s medical team, and they are intended for use by 
non-clinical staff to exclude any individuals with specific conditions. Quit Coaches will 
also educate participants on the utilization of the products and related side effects. 
Manufacturers’ information about side effects is given to the participant in written form 
and via a 1-800 number that has recorded information.  Quit coaches help participants 

problem solve around minor side effects (such as minor rash at site of the patch) and 
recommend that participants seek medical help for more serious side effects. 
• 
There is a six-month delay for participants to re-enroll in quitline services after study 
involvement to ensure all study data is collected.  
 
2. Benefits 
Please describe the benefits of conducting the project.  
 
• 
All participants may receive some satisfaction or indirect benefit from contributing to this 
trial. Participation in this research could increase health and quality of life if participants 
quit smoking and reduce or quit cannabis use. Participants will gain knowledge about 
quitting and reducing harmful substance use regardless of their quit status. Others may 
benefit by reduced exposure to second-hand smoke from tobacco or CB products if the 
participant reduces or quits either substance. If successful, this study could lead to 
improved tobacco cessation outcomes for those who also use cannabis, which would 
lead to improved health and longer lives.  
 
  
8. DATA HANDLING 
1. Data Protection, Storage and Transfer Plan  
  
See mitigations of risk above for Optum data handling processes. In addition:  
 
• 
Any personal information will be stored as electronic data in password-protected secure 
computer files, secured from unauthorized access. Data will be kept for at least 6 years 
after the study ends and related reports are published. Data will be completely destroyed 
once it is no longer needed.  
• 
Any published results will take the form of summary results; they will not report anything 
that would identify a specific person.  
• 
The research team at Optum will have access to the study data Only the minimal data 
required to complete the research will be accessed and analyzed. 
 
 
• 
Some study data may be shared with research partners and regulatory bodies.  This 
includes:  
o Researchers at University of Washington  
o Maryland Marketing Source (MMS) who may call you to complete your follow up 
survey; 
o Office of Human Research Affairs (OHRA) at United Health Group, who oversees 
our research, and; 
o National Institutes of Health, National Institute of Drug Abuse, who funds our 
research. 
• 
The parties named above may need to look at study records for this research study and 
related quality assurance, survey completion, or data analysis. In particular: 
o Co-Investigators at the University of Washington (Drs. Carlini and Walker will 
have access to recordings of study calls to assist with treatment fidelity 
monitoring. These recordings will be sent via Optum-approved secure file 
transfer processes following recommendations from Optum Compliance, Privacy 
and Legal (CPL).  Recordings will be deleted following fidelity coding procedures.   

o Dr. Beatriz Carlini will assist with interviewing participants at the end of their 
treatment. Interview recordings and notes will be stored on a password protected 
laptop and transferred to Optum via secure file transfer processes as required by 
CPL and deleted following study completion.  
 
2. Statistical Analysis 
See data analysis section above. 
3. Future Utilization 
Research findings will be: 
1. Used to inform product development if found to be effective at helping 
participants quit tobacco and/or decrease cannabis use. 
2. Disseminated via peer-reviewed publications and presentations at national 
conferences.  
  
4. Publication Plan 
 
Research findings will be disseminated as peer-reviewed publications and 
conference presentations. If applicable, findings may be used to secure funding for 
additional research and a fully powered randomized trial.  
  
9. QUALITY CONTROL, MONITORING AND REPORTING 
  
Service Delivery registration staff, Quit Coaches, and all study staff are required to complete the 
appropriate version of the CITI Human Subjects Research Training. Select coaches in the 
Research Implementation Unit (RIU) will be utilized for this project. RIU quit coaches have 
received additional training in research methods and have delivered QL interventions for 
multiple studies. They are also the coaches who deliver tailored clinical content to participants 
enrolled in the mental health QL program and other programs for special populations (e.g., 
youth, pregnant women).  Study coaches are trained Tobacco Specialists. In addition, they will 
attend a study-specific training lasting approximately 8 hours, with content on study procedures, 
the study intervention, and supplemental content around cannabis.  
 
In addition, the grant project manager (Helena Berlin) and Principal Investigator (Dr. Kelly 
Carpenter) have attended the NIH-required Good Clinical Practices (GCP) training (with 
refresher training every 3 years). Our research team follows GCP guidelines for documenting 
research procedures, including the development of a Standard Operating Procedures (SOP) 
manual to document standard practices and daily processes conducted to assure execution of 
research tasks in accordance with institutional, state, and federal guidelines. During the course 
of a study, all changes in procedures and deviations are documented in the SOP.  
 
 
 

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