E-cigarette Cessation in Adults Who Co-use Cannabis
A Prospective Trial of Varenicline and Incentives for E-cigarette Cessation in Adults Who Co-use Cannabis
Medical University of South Carolina
105 participants
Feb 19, 2025
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to better understand tobacco outcomes using a commonly prescribed stop smoking medication (varenicline) and financial incentives for adults who also use cannabis. Varenicline is not FDA approved for e-cigarette cessation, but is FDA approved for cigarette cessation. Investigators are also interested in how cannabis/marijuana and tobacco interact during a tobacco quit attempt. All participants will receive e-cigarette cessation treatment for 12 weeks. To qualify, participants must be between the ages of 18-40 and use both e-cigarettes and cannabis. Participants do not need to be interested in quitting cannabis to qualify. This study is being conducted at three sites: the Medical University of South Carolina in Charleston, SC, Behavioral Health Services in Pickens, SC, and MUSC Lancaster in Lancaster, SC.
Eligibility
Inclusion Criteria6
- Between the ages of 18 and 40 years old
- Use e-cigarettes daily or near daily in the past month
- Must submit a positive instant-read urine cotinine test at screening (≥ 200 ng/ml)
- Be interested in quitting use of e-cigarettes
- Must be willing to take varenicline for the standard 12-week course of treatment
- Self-reported use of cannabis on at least 10 out of the past 30 days or must submit a positive qualitative urinary cannabinoid test at screening (> 50 ng/ml)
Exclusion Criteria5
- Any serious or unstable medical/psychiatric disorder (including severe substance use disorders, other than cannabis or tobacco use disorders) in the past three months that may interfere with study performance
- Use of cigarettes on 10+ days in the past 30
- Currently pregnant or breastfeeding
- Current use of medications with smoking cessation efficacy
- Use of any medications that would interfere with varenicline
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Interventions
In this study, all participants will be administered active medication for a 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.
Contingency management procedures will be implemented and financial incentives will be provided at weekly visits contingent on e-cigarette 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.
Psychosocial counseling will be administered by trained research staff leading up to the target quit date and throughout the study.
Locations(3)
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NCT06688539