Your session is about to expire
← Back to Search
Smoking Cessation Agent
Varenicline + Incentives for Quitting Smoking
Phase 4
Waitlist Available
Led By Erin McClure, Ph.D.
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
Daily cigarette smoker for ≥ 6 months, smoking ≥ 5 cigarettes per day
Between the ages of 18 and 40 years old
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
Summary
This trial is testing whether a smoking cessation medication, varenicline, is more effective when used with financial incentives to quit smoking cigarettes. The study will also look at how cannabis/marijuana and tobacco interact during a tobacco quit attempt.
Who is the study for?
Adults aged 18-40 who smoke at least 5 cigarettes daily for over 6 months and want to quit smoking, scoring at least a 5 on a scale of interest in quitting. Participants must be willing to take varenicline for 12 weeks and if female, agree to use birth control during the study. Excluded are those with serious medical/psychiatric disorders, pregnant or lactating women, or those using other cessation drugs.Check my eligibility
What is being tested?
The trial is testing the effectiveness of varenicline (a stop-smoking medication) combined with financial incentives and counseling in helping tobacco users quit. It also examines how cannabis affects tobacco cessation efforts. All participants will receive this treatment combination for a duration of twelve weeks.See study design
What are the potential side effects?
Varenicline may cause nausea, sleep disturbances (like insomnia or vivid dreams), constipation, gas, vomiting; changes in taste; dry mouth; headache; drowsiness; tiredness/fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been smoking at least 5 cigarettes daily for over 6 months.
Select...
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
7-day point prevalence tobacco abstinence at the end of treatment (Week 12)
Secondary outcome measures
Changes in cannabis use during tobacco cessation treatment (among co-users)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Co-Use GroupExperimental Treatment3 Interventions
Cannabis and tobacco co-use group.
Group II: Tobacco Only GroupActive Control3 Interventions
Tobacco only group.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Varenicline
2011
Completed Phase 4
~4170
Contingency Management
2014
Completed Phase 2
~3430
Counseling
2017
Completed Phase 4
~1940
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
947 Previous Clinical Trials
7,397,860 Total Patients Enrolled
23 Trials studying Tobacco Use Disorder
2,584 Patients Enrolled for Tobacco Use Disorder
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,193 Total Patients Enrolled
93 Trials studying Tobacco Use Disorder
1,682,543 Patients Enrolled for Tobacco Use Disorder
National Institutes of Health (NIH)NIH
2,736 Previous Clinical Trials
7,507,742 Total Patients Enrolled
45 Trials studying Tobacco Use Disorder
25,920 Patients Enrolled for Tobacco Use Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been smoking at least 5 cigarettes daily for over 6 months.You must submit a breath CO sample of ≥ 7 ppm at the screening visit.I am between 18 and 40 years old.I haven't used tobacco products other than cigarettes in the last month.I am willing to take varenicline for 12 weeks.I am interested in quitting smoking, rating my interest 5 or higher.I am currently using medication to help me stop smoking.I am not taking any medications that would interfere with varenicline.I agree to use birth control during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Co-Use Group
- Group 2: Tobacco Only Group
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Tobacco Use Disorder Patient Testimony for trial: Trial Name: NCT04228965 — Phase 4
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger