E-cigarette Cessation in Adults Who Co-use Cannabis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-40
SponsorMedical University of South Carolina
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Varenicline Pill
DrugIn 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
BehavioralContingency 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.
Counseling
BehavioralPsychosocial counseling will be administered by trained research staff leading up to the target quit date and throughout the study.
Treatment groups
105 Participants
are divided into 1 treatment groupGroup A: Co-use groupOther 3 interventions
Trial outcomes
Primary outcomes
1
7-day point prevalence tobacco abstinence at the end of treatment (Week 12)
7-day point prevalence abstinence from e-cigarettes at the end of treatment (Week 12) will be assessed via biochemical verification (urinary cotinine; ng/ml) and will be compared to cigarette abstinence rates from the parent study (as historical controls)
Time frame
Final 7 days of treatment (Week 12)Secondary outcomes
1
Changes in cannabis use during e-cigarette cessation treatment
Cannabis use rates (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)2
Cannabis co-use severity on e-cigarette abstinence rates
Assess for a dose-dependent impact of cannabis co-use severity on e-cigarette cessation.
Time frame
Final 7 days of treatment (Week 12)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of South Carolina
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov