NCT06688539 E-cigarette Cessation in Adults Who Co-use Cannabis
| NCT ID | NCT06688539 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Medical University of South Carolina |
| Condition | Nicotine Dependence |
| Study Type | INTERVENTIONAL |
| Enrollment | 105 participants |
| Start Date | 2025-02-19 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 105 participants in total. It began in 2025-02-19 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Erin A McClure, PhD
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT06688539 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Nicotine Dependence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06688539 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06688539 currently recruiting?
Yes, NCT06688539 is actively recruiting participants. Contact the research team at chapmanb@musc.edu for enrollment information.
Where is the NCT06688539 trial being conducted?
This trial is being conducted at Charleston, United States, Lancaster, United States, Pickens, United States.
Who is sponsoring the NCT06688539 clinical trial?
NCT06688539 is sponsored by Medical University of South Carolina. The principal investigator is Erin A McClure, PhD at Medical University of South Carolina. The trial plans to enroll 105 participants.