Cannabis-Tobacco Co-Use Treatment Study

NCT06883162 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: Pro00136115R01CA290842
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tobacco Use Disorder; Tobacco Use Cessation; Cannabis Use; Marijuana Use; Cannabis Use Disorder

Outcome Measures

Primary Outcomes (1)

• Cigarette abstinence

  Biochemically-confirmed 7-day point prevalence abstinence from tobacco

  Final 7 days of treatment (Week 11 through Week 12)

Secondary Outcomes (2)

• Changes in cannabis use frequency

  Weeks 1 through 12 of treatment

• Changes in cannabis use amount

  Weeks 1 through 12 of treatment

Other Outcomes (1)

• Sex differences in tobacco and cannabis outcomes

  Weeks 1 through 12 of treatment

Study Arms (2)

Varenicline

EXPERIMENTAL

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; Behavioral: Counseling; Behavioral: Psychosocial modules

Placebo

PLACEBO COMPARATOR

Participants will be randomized 1:1 to varenicline or matched placebo.

Behavioral: Counseling; Behavioral: Psychosocial modules

Interventions

Varenicline DRUG

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.

Varenicline

Counseling BEHAVIORAL

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.

Placebo; Varenicline

Psychosocial modules BEHAVIORAL

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; Varenicline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Must submit a positive instant-read test for cotinine and cannabis prior to enrollment
• Must self-report cannabis use (THC-dominant products) on at 3 days per week out of the past 30 days
• Must be willing to take varenicline or placebo for 12 weeks
• Must reside in South Carolina

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina - Charleston

Charleston, South Carolina, 29403, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use Disorder; Tobacco Use Cessation; Marijuana Use

Interventions

Varenicline; Counseling

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Erin Mcclure

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Mcclure

CONTACT

843-792-7192; mccluree@musc.edu

Elizabeth Chapman

CONTACT

864-898-2992; chapmanb@musc.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor-Faculty

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 19, 2025
• Study Start: May 6, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)