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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up final 4 weeks of study treatment (weeks 8-12)
Awards & highlights

Study 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 below
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I have been smoking at least 5 cigarettes daily for over 6 months.
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I am between 18 and 40 years old.
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I am willing to take varenicline for 12 weeks.

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

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
2003
Completed Phase 2
~3220
Counseling
2017
Completed Phase 4
~1970

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
932 Previous Clinical Trials
7,394,182 Total Patients Enrolled
24 Trials studying Tobacco Use Disorder
2,684 Patients Enrolled for Tobacco Use Disorder
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,281 Total Patients Enrolled
93 Trials studying Tobacco Use Disorder
1,682,622 Patients Enrolled for Tobacco Use Disorder
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,331 Total Patients Enrolled
45 Trials studying Tobacco Use Disorder
26,012 Patients Enrolled for Tobacco Use Disorder

Media Library

Varenicline (Smoking Cessation Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04228965 — Phase 4
Tobacco Use Disorder Research Study Groups: Co-Use Group, Tobacco Only Group
Tobacco Use Disorder Clinical Trial 2023: Varenicline Highlights & Side Effects. Trial Name: NCT04228965 — Phase 4
Varenicline (Smoking Cessation Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04228965 — Phase 4
Tobacco Use Disorder Patient Testimony for trial: Trial Name: NCT04228965 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other scientific examples of a Tobacco Only Group?

"As of right now, there are 28 ongoing clinical trials that are studying the effects of Tobacco Only Group. 4 of those trials are currently in Phase 3. Although a majority of the trials are being conducted in Charleston, South carolina, there are 71 locations running these studies."

Answered by AI

If a potential patient is below the age of 35, will they be able to enroll in this research project?

"The age requirement to participate in this particular trial is between 18-40. There are a total of 5 studies for individuals under 18 and 105 for those over the age of 65."

Answered by AI

What dangers does the Tobacco Only Group present to people?

"The Power team gave Tobacco Only Group a score of 3 out of 3 because this treatment is approved and Phase 4 trials are typically only done for confirmatory purposes."

Answered by AI

How many volunteers will be helping with this experiment?

"That is correct. Currently, the trial is open and looking for 208 individuals from 4 different locations. The listing was first posted on January 28th, 2020 and was updated September 6th, 2022."

Answered by AI

I am interested in enrolling in this research project, is that possible?

"The target population for this research are 208 individuals that currently exhibit tobacco dependence. Furthermore, these individuals must also meet the following age, smoking frequency, and interest criteria: 18-40 years old, smokes cigarettes daily for at least 6 months, smokes at least 5 cigarettes a day, interested in quitting (defined as a score of 5 or higher on a 1-10 Likert scale [1=not at all interested, 10=extremely interested])."

Answered by AI

Are recruitment efforts for this particular clinical trial still underway?

"The study is presently recruiting participants, as noted in the clinicaltrials.gov listing. This listing was originally posted on 1/28/2020 and was last edited on 9/6/2022."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
North Carolina
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
3+
What site did they apply to?
Medical University of South Carolina - Florence
Medical University of South Carolina - Charleston

Why did patients apply to this trial?

I am desperate to try anything to help me quit smoking. I have tried everything.
PatientReceived no prior treatments
I am hoping that with the help of this clinical trial I will be able to quit smoking permanently.
PatientReceived 2+ prior treatments
I have attempted to quit smoking a few times only cold turkey, because I have always been afraid to try any medications. All the ones I had heard of people didn't like or had a bad experience.this one I would like to give it a shot because I will try anything at this point.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Cannabis and Tobacco Co-use Study
Erin McClure 2020. "Cannabis and Tobacco Co-use Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04228965.
All > Chantix
~0 spots leftby May 2024
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