Cannabis and Tobacco Co-use Study

NCT04228965 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: 00086954R37CA237245
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Biologically Verified 7-day Point Prevalence Tobacco Abstinence at the End of Treatment (Week 12)

  7-day point prevalence abstinence from tobacco at the end of treatment (Week 12) will be assessed via biochemical verification (urinary cotinine; ng/ml) and will be compared between cannabis co-users and tobacco only controls.

  Final 7 days of treatment (Week 12)

Secondary Outcomes (1)

• Cannabis Use During Tobacco Cessation Treatment (Among Co-users)

  Final 4 weeks of study treatment (Weeks 9-12)

Study Arms (2)

Co-Use Group

OTHER

Cannabis and tobacco co-use group.

Drug: Varenicline; Behavioral: Contingency Management; Behavioral: Counseling

Tobacco Only Group

ACTIVE COMPARATOR

Tobacco only group.

Drug: Varenicline; Behavioral: Contingency Management; Behavioral: Counseling

Interventions

Varenicline DRUG

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.

Also known as: Chantix

Co-Use Group; Tobacco Only Group

Contingency Management BEHAVIORAL

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.

Co-Use Group; Tobacco Only Group

Counseling BEHAVIORAL

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.

Co-Use Group; Tobacco Only Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Between the ages of 18 and 40 years old
• Must be able to understand the study and provide written informed consent
• Daily cigarette smoker for ≥ 6 months, smoking ≥ 5 cigarettes per day
• Must submit a breath carbon monoxide (CO) sample of ≥ 7 parts per million (ppm) at the screening visit
• Be interested in quitting smoking tobacco cigarettes (defined as a 5 or above on a 10-point Likert scale assessing interest in quitting \[1=not at all interested, 10=extremely interested\])
• Must be willing to take varenicline for the standard 12-week course of treatment
• If female, agreement to use birth control (any form) to avoid pregnancy during study procedures
• Self-reported use of cannabis on at least 10 out of the past 30 days or submit a positive qualitative urinary cannabinoid test at screening (limit of detection is 50 ng/ml)

You may not qualify if:

• Any serious or unstable medical/psychiatric disorder (including severe substance use disorders, other than cannabis or tobacco use disorders) or other significant concern in the past three months that may interfere with study performance, impact participant safety, compliance with study procedures, or potentially confound the interpretation of findings
• Currently pregnant, lactating, or contemplating pregnancy in the next 6 months
• Current use of medications with smoking cessation efficacy
• Use of any medications that would interfere with varenicline
• No regular use of other tobacco or nicotine products other than combustible cigarettes (e.g., smokeless tobacco, electronic cigarettes, etc.) in the past month prior to the quit attempt

Sponsors & Collaborators

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

Study Sites (3)

Medical University of South Carolina - Charleston

Charleston, South Carolina, 29403, United States

Location

Medical University of South Carolina - Florence

Florence, South Carolina, 29505, United States

Location

Behavioral Health Services of Pickens County

Pickens, South Carolina, 29671, United States

Location

Related Publications (1)

• Walters KJ, Baker NL, Tomko RL, Gray KM, Carpenter MJ, McClure EA. Determining the impact of cannabis use and severity on tobacco cessation outcomes: study protocol for a prospective tobacco treatment trial. BMC Psychol. 2023 Jan 25;11(1):25. doi: 10.1186/s40359-023-01060-2.

  PMID: 36698194 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation

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

Results Point of Contact

• Title: Erin A. McClure, Principal Investigator
• Organization: Medical University of South Carolina

mccluree@musc.edu

843-792-7192

Study Officials

• Erin McClure, Ph.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: January 14, 2020
• Study Start: January 28, 2020
• Primary Completion: June 12, 2024
• Study Completion: September 13, 2024
• Last Updated: June 15, 2025
• Results First Posted: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)