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.
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: Final 4 weeks of study treatment (Weeks 8-12)
Week 8
Changes in cannabis use during tobacco cessation treatment (among co-users)
Week 12
7-day point prevalence tobacco abstinence at the end of treatment (Week 12)
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
1 Treatment Group
Tobacco Only Group
1 of 1
Active Control
208 Total Participants · 1 Treatment Group
Primary Treatment: Tobacco Only Group · No Placebo Group · Phase 4
Tobacco Only GroupActiveComparator Group · 3 Interventions: Varenicline, Contingency Management, Counseling · Intervention Types: Drug, Behavioral, Behavioral
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: final 4 weeks of study treatment (weeks 8-12)
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
838 Previous Clinical Trials
5,378,360 Total Patients Enrolled
22 Trials studying Tobacco Use Disorder
2,301 Patients Enrolled for Tobacco Use Disorder
National Cancer Institute (NCI)NIH
13,087 Previous Clinical Trials
41,141,498 Total Patients Enrolled
90 Trials studying Tobacco Use Disorder
1,682,072 Patients Enrolled for Tobacco Use Disorder
National Institutes of Health (NIH)NIH
2,442 Previous Clinical Trials
24,578,070 Total Patients Enrolled
43 Trials studying Tobacco Use Disorder
26,208 Patients Enrolled for Tobacco Use Disorder
Erin McClure, Ph.D.Principal Investigator - Medical University of South Carolina
Northside Hospital, Children's Healthcare of Atlanta at Scottish Rite, Northside Hospital - Forsyth
Medical School - State University of New York, Downstate Medical Center, Doctor of Medicine
Orlando Regional Medical Center, Residency in Internal Medicine
Eligibility Criteria
Age 18 - 40 · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are a daily cigarette smoker for ≥ 6 months, smoking ≥ 5 cigarettes per day.
You must submit a breath CO sample of ≥ 7 ppm at the screening visit.
You are interested in quitting smoking tobacco cigarettes.
Who else is applying?
What state do they live in?
| North Carolina | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
Why did patients apply to this trial?
- "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."
How many prior treatments have patients received?
| 0 | 100.0% |
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Conditions
Cancer Related
Treatments