Clavulanic Acid for Quitting Smoking

Overseen by Brett 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

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.

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.

Treatment Details

Interventions

• Clavulanic Acid (Beta-lactamase Inhibitor)
• Placebo oral capsule (Behavioural Intervention)

Trial Overview The 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

Group I: Clav Active Control 1 Intervention

4-day 125 bid oral capsule administration

Group II: Placebo Placebo Group 1 Intervention

4-day, twice-daily oral capsule administration

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+