Clavulanic Acid for Quitting Smoking

Overseen By Madhura Athreya, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Missouri-Columbia

Must not be taking: Antidepressants, Carbamazepine, Nitroglycerin

Disqualifiers: Neurological disorders, Psychosis, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 4 days

30 Participants Needed

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)

Functional vision (with corrective lenses as needed) to complete assigned assessments and tasks

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive either clavulanic acid or placebo for 4 days, with twice-daily oral capsule administration

4 days

Daily visits for capsule administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including fMRI and biochemical assessments

1 day

1 visit (in-person)

Treatment Details

Interventions

• Clavulanic Acid
• Placebo oral capsule

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+