Cannabis and Tobacco Co-use Study
Primary Purpose
Tobacco Use Disorder
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Varenicline
Contingency Management
Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Tobacco Use Disorder focused on measuring Smoking Cessation
Eligibility Criteria
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
Sites / Locations
- Medical University of South Carolina - CharlestonRecruiting
- Medical University of South Carolina - FlorenceRecruiting
- Behavioral Health Services of Pickens CountyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Co-Use Group
Tobacco Only Group
Arm Description
Cannabis and tobacco co-use group.
Tobacco only group.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04228965
First Posted
December 11, 2019
Last Updated
September 5, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Cancer Institute (NCI), National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT04228965
Brief Title
Cannabis and Tobacco Co-use Study
Official Title
A Prospective Trial of Varenicline and Incentives for Tobacco Cessation in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 28, 2020 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
September 2, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Cancer Institute (NCI), National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
Smoking Cessation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
208 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Co-Use Group
Arm Type
Other
Arm Description
Cannabis and tobacco co-use group.
Arm Title
Tobacco Only Group
Arm Type
Active Comparator
Arm Description
Tobacco only group.
Intervention Type
Drug
Intervention Name(s)
Varenicline
Other Intervention Name(s)
Chantix
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
7-day point prevalence tobacco abstinence at the end of treatment (Week 12)
Description
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.
Time Frame
Final 7 days of treatment (Week 12)
Secondary Outcome Measure Information:
Title
Changes in cannabis use during tobacco cessation treatment (among co-users)
Description
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.
Time Frame
Final 4 weeks of study treatment (Weeks 8-12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Chapman
Phone
864-898-2992
Email
chapmanb@musc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Emma Mandel
Phone
843-792-4097
Email
mandele@musc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin McClure, Ph.D.
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina - Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Mandel
Phone
843-792-4097
Email
mandele@musc.edu
Facility Name
Medical University of South Carolina - Florence
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29505
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Mandel
Phone
843-792-4097
Email
smokingstudy@musc.edu
Facility Name
Behavioral Health Services of Pickens County
City
Pickens
State/Province
South Carolina
ZIP/Postal Code
29671
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Chapman
Phone
864-898-2992
Email
chapmanb@musc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Cannabis and Tobacco Co-use Study
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