Actively Recruiting

Phase 3
Age: 18Years +
All Genders
Healthy Volunteers
ID06883162

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

Led by Medical University of South Carolina · Updated on 2026-04-03

200

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

Sponsors

M

Medical University of South Carolina

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate the effectiveness of varenicline, compared to a placebo, for adults who regularly use both cigarettes and cannabis. The study focuses on supporting participants in quitting cigarettes and reducing or stopping cannabis use. It is conducted remotely by the Medical University of South Carolina, enrolling adults aged 18 and older who live in South Carolina and are interested in quitting or reducing their tobacco and cannabis consumption.

CONDITIONS

Brief Title

Cannabis-Tobacco Co-Use Treatment Study

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Ages 18 and over (no upper age limit)
  • Smoke at least 5 tobacco cigarettes per day on at least 20 of the past 30 days for the past 3 months
  • Interested in quitting tobacco
  • Interested in reducing or stopping cannabis use
  • Positive test for cotinine and cannabis before enrollment
  • Self-reported cannabis use on at least 3 days per week in the past 30 days
  • Willing to take varenicline or placebo for 12 weeks
  • Reside in South Carolina
Not Eligible

You will not qualify if you...

  • Significant or unstable medical, psychiatric, or substance use problems that affect safety or participation
  • Pregnant or trying to become pregnant
  • Use of medications for smoking cessation
  • Regular use of e-cigarettes or other tobacco products on 10 or more days in the past month

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (remote)

Treatment

Duration - 12 weeks

Participants receive 12 weeks of treatment with either varenicline or placebo combined with weekly skills-based counseling and access to online psychosocial modules to support tobacco cessation and cannabis use reduction or abstinence.

Weekly remote visits for counseling and medication monitoring

Trial Site Locations

Total: 1 location

1

Medical University of South Carolina - Charleston

Charleston, South Carolina, United States, 29403

Actively Recruiting

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Research Team

E

Erin Mcclure

E

Elizabeth Chapman

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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