Clavulanic Acid for Quitting Smoking
BF
Overseen byBrett Froeliger, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Missouri-Columbia
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This research study is looking into the effects of clavulanic on smoking behavior in adult cigarette smokers. The primary study hypothesis is that, compared to placebo, clavulanic acid will reduce smoking over the course of the study.
Research Team
BF
Brett Froeliger, PhD
Principal Investigator
University of Missouri-Columbia
Eligibility Criteria
This trial is for adults aged 18-65 who have been smoking more than 10 cigarettes a day for at least two years and can confirm inhalation. Participants must speak English, have functional vision, and women must test negative in a pregnancy test. They should not use other tobacco or nicotine products during the study.Inclusion Criteria
English fluency
Smoke > 10 cigarettes/day for a minimum of 2 yrs. and have an expired carbon monoxide (CO) concentration of ≥ 10 ppm (to confirm inhalation at screening and scanning)
I am between 18 and 65 years old.
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Exclusion Criteria
I am taking antidepressants that help with quitting smoking.
Positive pregnancy test (Urine pregnancy testing at screening and prior to fMRI scan) or currently breast feeding or BAC greater than 0.0
I have not had electroconvulsive therapy in the last 6 months.
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Treatment Details
Interventions
- Clavulanic Acid (Beta-lactamase Inhibitor)
- Placebo oral capsule (Behavioural Intervention)
Trial OverviewThe study is testing clavulanic acid's impact on cigarette smokers' behavior by comparing it to a placebo. The main goal is to see if clavulanic acid helps reduce smoking compared to the placebo over time.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: ClavActive Control1 Intervention
4-day 125 bid oral capsule administration
Group II: PlaceboPlacebo Group1 Intervention
4-day, twice-daily oral capsule administration
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Missouri-Columbia
Lead Sponsor
Trials
387
Recruited
629,000+