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Nicotinic Acetylcholine Receptor Partial Agonist

Co-use group for Tobacco Use Disorder (Vape CAT Trial)

Phase 4
Waitlist Available
Led By Erin A McClure, PhD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Between the ages of 18 and 40 years old
* Use e-cigarettes daily or near daily in the past month
Timeline
Screening 3 weeks
Treatment Varies
Follow Up final 4 weeks of study treatment (weeks 8-12)
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

The purpose of this study is to better understand tobacco outcomes using a commonly prescribed stop smoking medication (varenicline) and financial incentives for adults who also use cannabis. Varenicline is not FDA approved for e-cigarette cessation, but is FDA approved for cigarette cessation. Investigators are also interested in how cannabis/marijuana and tobacco interact during a tobacco quit attempt. All participants will receive e-cigarette cessation treatment for 12 weeks. To qualify, participants must be between the ages of 18-40 and use both e-cigarettes and cannabis. Participants do not need to be interested in quitting cannabis to qualify. This study is being conducted at three sites: the Medical University of South Carolina in Charleston, SC, Behavioral Health Services in Pickens, SC, and MUSC Lancaster in Lancaster, SC.

Who is the study for?
This trial is for adults aged 18-40 who use both e-cigarettes and cannabis. They don't need to want to quit using cannabis but should be interested in stopping e-cigarette use. The study takes place at three locations in South Carolina.
What is being tested?
The study tests the effectiveness of varenicline, a pill approved for cigarette cessation, combined with financial rewards and counseling, to help people stop using e-cigarettes. Participants will receive this treatment over a period of 12 weeks.
What are the potential side effects?
Varenicline may cause nausea, sleep problems (insomnia or vivid dreams), constipation, gas, and vomiting. It can also lead to changes in taste or increased appetite.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~final 4 weeks of study treatment (weeks 8-12)
This trial's timeline: 3 weeks for screening, Varies for treatment, and final 4 weeks of study treatment (weeks 8-12) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
7-day point prevalence tobacco abstinence at the end of treatment (Week 12)
Secondary study objectives
Cannabis co-use severity on e-cigarette abstinence rates
Changes in cannabis use during e-cigarette cessation treatment

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Co-use groupExperimental Treatment3 Interventions
E-cigarette and cannabis co-use group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Varenicline Pill
2019
Completed Phase 4
~380
Contingency management
2006
Completed Phase 4
~1020
Counseling
2017
Completed Phase 4
~1830

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,924 Previous Clinical Trials
41,017,919 Total Patients Enrolled
97 Trials studying Tobacco Use Disorder
1,683,302 Patients Enrolled for Tobacco Use Disorder
Medical University of South CarolinaLead Sponsor
972 Previous Clinical Trials
7,399,197 Total Patients Enrolled
25 Trials studying Tobacco Use Disorder
2,813 Patients Enrolled for Tobacco Use Disorder
Erin A McClure, PhDPrincipal InvestigatorMedical University of South Carolina
~70 spots leftby Jun 2026
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