Cannabis-Tobacco Co-Use Treatment Study (RECLAIM)

Randomized Controlled Trial of Varenicline to Treat Tobacco and Cannabis Co-Use (RECLAIM)

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.

Study Overview

• Status: Recruiting
• Conditions: Tobacco Use Disorder; Marijuana Use; Tobacco Use Cessation; Cannabis Use; Cannabis Use Disorder
• Intervention / Treatment: Drug: Varenicline; Behavioral: Counseling; Behavioral: Psychosocial modules

Detailed Description

Tobacco-cannabis co-use results in established harms, yet there are currently no recommended treatment strategies for co-use. The scientific premise of this proposal is based on work conducted by our group demonstrating that: 1) cannabis co-use adversely impacts cigarette abstinence and those co-using cannabis have nearly double the odds of tobacco treatment failure, 2) varenicline may be efficacious in treating CUD, and 3) cannabis reduction (vs. abstinence) may be a potentially more appealing treatment goal. Therefore, this project proposes to evaluate varenicline versus placebo on cigarette abstinence and cannabis use reduction or abstinence among adults who co-use. To bolster outcomes, both groups will receive an evidence-based psychosocial intervention that includes real-time and asynchronously delivered content (all delivered virtually), that leverages the co-use intervention used by Budney (Consultant) as well brief weekly counseling and check-in sessions that we have used in previous and ongoing studies. Asynchronous content (web-based modules) is standardized and through a tailored approach to counseling, the intervention will allow for participant preference for cannabis reduction or abstinence. The selection of this combination treatment for tobacco-cannabis co-use is based on rigorous prior research demonstrating: 1) efficacy of varenicline for tobacco cessation, 2) preliminary efficacy of varenicline for cannabis use, and 3) acceptable, psychosocial co-use treatment modules that have the potential to augment a robust pharmacotherapy to improve outcomes.

Investigators propose a completely remote 12-week treatment trial among adults in South Carolina (ages 18+; N=200) who co-use cigarettes and cannabis regularly. Participants will be included who smoke cigarettes daily or near daily (20+ days in the past 30) and have used cannabis at least 3 times per week in the past month. Participants will be randomized 1:1 to varenicline or placebo and all participants will receive the platform psychosocial intervention. The aims of the study are to: 1) evaluate rates of 7-day biochemically confirmed point prevalence abstinence (PPA) from cigarettes at the 12-week EOT visit comparing varenicline + psychosocial intervention to the placebo + psychosocial intervention participants (Aim 1), 2) compare cannabis use frequency and amount between varenicline and placebo groups during treatment (Weeks 1-12; Aim 2), and 3) explore differential treatment outcomes among male vs. female participants (Exploratory Aim).

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Elizabeth Chapman; Phone Number: 864-898-2992; Email: chapmanb@musc.edu
• Study Contact Backup: Name: Erin Mcclure; Phone Number: 843-792-7192; Email: mccluree@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29403
      • Recruiting
      • Medical University of South Carolina - Charleston
      • Contact: Elizabeth Chapman; Phone Number: 864-898-2992; Email: chapmanb@musc.edu
      • Contact: Ela Williams; Email: williela@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

1. Ages 18 and over (no upper age limit)
2. Must smoke at least 5 tobacco cigarettes per day on at least 20 out of the past 30 days for the past 3 months
3. Must express interest in quitting tobacco
4. Must express interest in cannabis reduction and/or cessation
5. Must submit a positive instant-read test for cotinine and cannabis prior to enrollment
6. Must self-report cannabis use (THC-dominant products) on at 3 days per week out of the past 30 days
7. Must be willing to take varenicline or placebo for 12 weeks
8. Must reside in South Carolina

Exclusion criteria:

1. 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
2. Pregnant or trying to become pregnant
3. Use of medications with smoking cessation efficacy
4. Regular use of e-cigarettes or other tobacco products (<10 days in the past month)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Varenicline; Participants 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.	Drug: Varenicline; Participants 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.; Behavioral: Counseling; Research 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.; Behavioral: Psychosocial modules; Participants 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.
Placebo Comparator: Placebo; Participants will be randomized 1:1 to varenicline or matched placebo.	Behavioral: Counseling; Research 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.; Behavioral: Psychosocial modules; Participants 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cigarette abstinence	Biochemically-confirmed 7-day point prevalence abstinence from tobacco	Final 7 days of treatment (Week 11 through Week 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cannabis use frequency	Assess changes in cannabis using days (frequency) during treatment	Weeks 1 through 12 of treatment
Changes in cannabis use amount	Assess changes in sessions (episodes) of cannabis use per day (amount) during treatment	Weeks 1 through 12 of treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Weeks 1 through 12 of treatment

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Erin Mcclure, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: March 6, 2025
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 19, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Health Behavior; Marijuana Use; Tobacco Use Disorder; Tobacco Use Cessation; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Behavioral Disciplines and Activities; Benzazepines; Mental Health Services; Quinoxalines; Varenicline; Counseling
• Other Study ID Numbers: Pro00136115; R01CA290842 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A final de-identified data set will be made available for retrieval and analysis of secondary outcomes, upon request to the Principal Investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No