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Nicotinic Acetylcholine Receptor Partial Agonist
Varenicline + Counseling for Smoking Addiction (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
Must be willing to take varenicline for the standard 12-week course of treatment
Must not have
Use of any medications that would interfere with varenicline
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
This trial aims to study the effects of a stop smoking medication called varenicline and financial incentives on adults who use both e-cigarettes and cannabis. The medication is approved by the FDA to help people
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 belowSelect...
I am between 18 and 40 years old.
Select...
I am willing to take varenicline for 12 weeks.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not taking any medications that would interfere with varenicline.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ final 4 weeks of study treatment (weeks 8-12)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~final 4 weeks of study treatment (weeks 8-12)
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
13,938 Previous Clinical Trials
41,023,083 Total Patients Enrolled
97 Trials studying Tobacco Use Disorder
1,683,302 Patients Enrolled for Tobacco Use Disorder
Medical University of South CarolinaLead Sponsor
976 Previous Clinical Trials
7,398,882 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