Cannabis-Tobacco Co-Use Treatment Study
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina
About this trial
The purpose of the RECLAIM study is to evaluate the effectiveness of varenicline (sometimes known as Chantix) compared to placebo (an inactive substance) for the treatment of cigarettes and cannabis (marijuana). Varenicline is not FDA approved for the combination treatment of cigarette abstinence and cannabis reduction or abstinence. All participants will also receive counseling and access to online treatment modules during a quit attempt for cigarettes and a reduction attempt for cannabis. This study is being conducted by the Medical University of South Carolina. All procedures are conducted remotely and there is no in-person visits are needed.
To qualify, participants must be 18 or older, live in South Carolina, use cigarettes and cannabis, and are interested in quitting cigarettes and reducing cannabis.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Ages 18 and over (no upper age limit)
Must smoke at least 5 tobacco cigarettes per day on at least 20 out of the past 30 days for the past 3 months
Must express interest in quitting tobacco
Must express interest in cannabis reduction and/or cessation
Disqualifiers
Any significant or acutely unstable medical, psychiatric, or substance use problem (including clinically significant disorders) that would contraindicate research, interfere with safety, compromise data integrity, or preclude consistent study participation
Pregnant or trying to become pregnant
Use of medications with smoking cessation efficacy
Regular use of e-cigarettes or other tobacco products (<10 days in the past month)
Trial design
Design model
Parallel
Treatments tested in this trial
Varenicline
DrugParticipants will be randomized 1:1 to varenicline or matched placebo. 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 mg b.i.d. starting on Day 8. Dosing of 2 mg per day will be maintained for the next 11 weeks.
Counseling
BehavioralResearch staff will provide skills-based counseling at weekly visits. Weekly counseling sessions will include discussion of online intervention modules, while providing skills-based strategies focused on enlisting social support, recognizing triggers, managing craving/withdrawal/stress, etc. Staff will use motivational enhancement techniques to address tobacco cessation, cannabis reduction or abstinence, and medication adherence.
Psychosocial modules
BehavioralParticipants will have access to online modules addressing tobacco and cannabis co-use to support cessation and/or reduction. Content includes 12 virtual modules combining cognitive behavioral therapy (CBT) and motivational enhancement (MET) to address tobacco, cannabis, and their co-use.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: VareniclineExperimental treatment 3 interventions
Group B: PlaceboPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Cigarette abstinence
Biochemically-confirmed 7-day point prevalence abstinence from tobacco
Time frame
Final 7 days of treatment (Week 11 through Week 12)Secondary outcomes
1
Changes in cannabis use frequency
Assess changes in cannabis using days (frequency) during treatment
Time frame
Weeks 1 through 12 of treatment2
Changes in cannabis use amount
Assess changes in sessions (episodes) of cannabis use per day (amount) during treatment
Time frame
Weeks 1 through 12 of treatmentOther outcomes
1
Sex differences in tobacco and cannabis outcomes
Biochemically-confirmed 7-day point prevalence abstinence from tobacco, cannabis use days and sessions of cannabis use per day
Time frame
Weeks 1 through 12 of treatmentSponsors 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