Cannabis and Tobacco Co-use Study

Study Overview
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Brief Summary
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The purpose of this study is to better understand tobacco outcomes using a well-known stop smoking medication, varenicline, and financial incentives with tobacco users. The investigators are also interested in how cannabis/marijuana and tobacco interact during a tobacco quit attempt. All participants will receive tobacco cessation treatment (varenicline) for 12 weeks. This study will recruit adult tobacco users (ages 18-40) who are motivated to quit smoking cigarettes.

Detailed Description
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Cannabis co-use among tobacco users is exceedingly common and rates of co-use appear to be increasing among adults in the US, which is consistent with overall increases in cannabis use rates among US adults. Given the current cannabis landscape, further increases in cannabis use are likely and may result in continued increases in the co-use of cannabis and tobacco. Despite high rates of co-use, there is little consensus regarding treatment recommendations for this population and an understanding of the impact of co-use on successful cessation. The literature on the impact of co-use on tobacco cessation outcomes specifically has been mixed and fraught with limitations, including methodological variation, lack of biochemical verification to confirm cannabis use status and severity, and variations in study samples. Currently, no prospective studies have been conducted to evaluate the impact of cannabis use on tobacco cessation outcomes. Further, no studies have collected cannabis use changes during tobacco cessation treatment to assess for concurrent reductions, abstinence, or of greater concern, compensatory (i.e., increased) use as a result of tobacco reduction/abstinence. This study is a prospective 12-week tobacco cessation trial using established methods and outcomes typical of tobacco cessation trials, but specifically recruiting co-users of cannabis. The aims of this proposed study are to; 1) examine the impact of cannabis co-use on tobacco cessation outcomes among co-users compared to tobacco only participants (Aim #1), 2) among cannabis co-users, assess changes in cannabis use during tobacco treatment (Aim #2), and 3) assess for a dose-dependent impact of cannabis co-use severity on tobacco cessation (Exploratory Aim #1).

Official Title
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A Prospective Trial of Varenicline and Incentives for Tobacco Cessation in Adults

Conditions
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Tobacco Use Disorder

Intervention / Treatment
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* Drug: Varenicline
* Behavioral: Contingency Management
* Behavioral: Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between the ages of 18 and 40 years old Must be able to understand the study and provide written informed consent Daily cigarette smoker for ≥ 6 months, smoking ≥ 5 cigarettes per day Must submit a breath carbon monoxide (CO) sample of ≥ 7 parts per million (ppm) at the screening visit Be interested in quitting smoking tobacco cigarettes (defined as a 5 or above on a 10-point Likert scale assessing interest in quitting [1=not at all interested, 10=extremely interested]) Must be willing to take varenicline for the standard 12-week course of treatment If female, agreement to use birth control (any form) to avoid pregnancy during study procedures Additional inclusion criteria will be implemented for cannabis co-users, which include: Self-reported use of cannabis on at least 10 out of the past 30 days or submit a positive qualitative urinary cannabinoid test at screening (limit of detection is 50 ng/ml) Exclusion Criteria: Any serious or unstable medical/psychiatric disorder (including severe substance use disorders, other than cannabis or tobacco use disorders) or other significant concern in the past three months that may interfere with study performance, impact participant safety, compliance with study procedures, or potentially confound the interpretation of findings Currently pregnant, lactating, or contemplating pregnancy in the next 6 months Current use of medications with smoking cessation efficacy Use of any medications that would interfere with varenicline No regular use of other tobacco or nicotine products other than combustible cigarettes (e.g., smokeless tobacco, electronic cigarettes, etc.) in the past month prior to the quit attempt

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Co-Use Group<br>Cannabis and tobacco co-use group. | Drug: Varenicline<br>* Varenicline is a medication approved by the Food and Drug Administration for the treatment of tobacco use disorder among adults (ages 18 and over). In this study, all participants will be administered active medication for the recommended 12 week treatment period. The standard dose titration schedule will be used, which includes 0.5 mg once per day (q.d.) on Days 1-3, 0.5 mg twice per day (b.i.d.) on Days 4-7, and 1.0 mg b.i.d. starting on Day 8. Dosing of 2.0 mg per day will be maintained for the next 11 weeks, for a total of 12 weeks of active treatment for all study participants.<br>* Other names: Chantix;Behavioral: Contingency Management<br>* Contingency management procedures will be implemented and financial incentives will be provided at weekly visits contingent on tobacco abstinence verified through urinary qualitative cotinine (starting at Week 2). A set amount of $20 per study visit will be delivered based on a negative qualitative urinary cotinine result.<br>Behavioral: Counseling<br>* Psychosocial counseling will be administered by trained research staff leading up to the target quit date and throughout the study. Counseling will include motivational enhancement for medication adherence and tobacco cessation. The content of counseling will be skills-based and will focus on enlisting social support, recognizing smoking triggers, managing craving/withdrawal/stress, etc.<br>|
| Active Comparator: Tobacco Only Group<br>Tobacco only group. | Drug: Varenicline<br>* Varenicline is a medication approved by the Food and Drug Administration for the treatment of tobacco use disorder among adults (ages 18 and over). In this study, all participants will be administered active medication for the recommended 12 week treatment period. The standard dose titration schedule will be used, which includes 0.5 mg once per day (q.d.) on Days 1-3, 0.5 mg twice per day (b.i.d.) on Days 4-7, and 1.0 mg b.i.d. starting on Day 8. Dosing of 2.0 mg per day will be maintained for the next 11 weeks, for a total of 12 weeks of active treatment for all study participants.<br>* Other names: Chantix;Behavioral: Contingency Management<br>* Contingency management procedures will be implemented and financial incentives will be provided at weekly visits contingent on tobacco abstinence verified through urinary qualitative cotinine (starting at Week 2). A set amount of $20 per study visit will be delivered based on a negative qualitative urinary cotinine result.<br>Behavioral: Counseling<br>* Psychosocial counseling will be administered by trained research staff leading up to the target quit date and throughout the study. Counseling will include motivational enhancement for medication adherence and tobacco cessation. The content of counseling will be skills-based and will focus on enlisting social support, recognizing smoking triggers, managing craving/withdrawal/stress, etc.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day point prevalence tobacco abstinence at the end of treatment (Week 12) | 7-day point prevalence abstinence from tobacco at the end of treatment (Week 12) will be assessed via biochemical verification (urinary cotinine; ng/ml) and will be compared between cannabis co-users and tobacco only controls. | Final 7 days of treatment (Week 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cannabis use during tobacco cessation treatment (among co-users) | Among cannabis co-users, cannabis use rates and amounts (based on urinary cannabinoids [ng/ml]) during the final 4 weeks of tobacco treatment (Weeks 8-12) will be assessed. | Final 4 weeks of study treatment (Weeks 8-12) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Cessation