Cannabis and Tobacco Co-use Study

• Status: Recruiting
• Trial end date: 2024-04-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Treatments: Varenicline

Criteria

Inclusion Criteria:

1. Between the ages of 18 and 40 years old

2. Must be able to understand the study and provide written informed consent

3. Daily cigarette smoker for ≥ 6 months, smoking ≥ 5 cigarettes per day

4. Must submit a breath carbon monoxide (CO) sample of ≥ 7 parts per million (ppm) at the screening visit

5. 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])

6. Must be willing to take varenicline for the standard 12-week course of treatment

7. 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:

8. 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:

1. 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

2. Currently pregnant, lactating, or contemplating pregnancy in the next 6 months

3. Current use of medications with smoking cessation efficacy

4. Use of any medications that would interfere with varenicline

5. 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 screening