Cannabis and Tobacco Co-use Study

Summary

The purpose of this study is to better understand tobacco outcomes using a well-known stop smoking medication, varenicline, and financial incentives with tobacco users. The investigators are also interested in how cannabis/marijuana and tobacco interact during a tobacco quit attempt. All participants will receive tobacco cessation treatment (varenicline) for 12 weeks. This study will recruit adult tobacco users (ages 18-40) who are motivated to quit smoking cigarettes.

Conditions

• Tobacco Use Disorder

Interventions

DRUG

Varenicline

Varenicline is a medication approved by the Food and Drug Administration for the treatment of tobacco use disorder among adults (ages 18 and over). In this study, all participants will be administered active medication for the recommended 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.

BEHAVIORAL

Contingency Management

Contingency management procedures will be implemented and financial incentives will be provided at weekly visits contingent on tobacco 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.

BEHAVIORAL

Counseling

Psychosocial counseling will be administered by trained research staff leading up to the target quit date and throughout the study. Counseling will include motivational enhancement for medication adherence and tobacco cessation. The content of counseling will be skills-based and will focus on enlisting social support, recognizing smoking triggers, managing craving/withdrawal/stress, etc.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• National Institutes of Health (NIH)

  collaborator NIH

• Medical University of South Carolina

  lead OTHER

Principal Investigators

• Erin McClure, Ph.D. · Medical University of South Carolina

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-28

Primary Completion

2024-06-12

Completion

2024-09-13

FDA Drug

Yes

Countries

• United States

Study Locations