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Beta-lactamase Inhibitor

Clavulanic Acid for Quitting Smoking

Phase 2
Recruiting
Led By Brett Froeliger, PhD
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-65 years
Agrees to refrain from all other tobacco (i.e., dip/chew, cigars, cigarillos) and/or nicotine products (i.e., e-cigs, patches, gum/lozenges, inhalers/sprays) for the duration of study participation
Must not have
Past head injury or primary neurological disorder associated with MRI abnormalities, including dementia, MCI, brain tumors, epilepsy, Parkinson's disease, or demyelinating diseases
Any physical or intellectual disability affecting completion of assessments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 days

Summary

This trial is testing whether a drug called clavulanic acid can help people quit smoking.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, participants may experience unexpected reactions from taking clavulanic acid or the placebo which will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I agree not to use any tobacco or nicotine products during the study.
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I have provided a negative pregnancy test result.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a head injury or a brain condition that shows up on MRI scans.
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I do not have disabilities that prevent me from completing health assessments.
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My kidney function tests are outside the normal range.
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I have a serious illness that hasn't been treated yet.
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I haven't taken carbamazepine, nitroglycerin, or similar risky drugs with CLAV in the last 14 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cigarette Smoking
Self Reported Side Effects
Secondary study objectives
Magnitude of change in BOLD fMRI brain response to smoking related images
Magnitude of change in resting-stated fMRI brain connectivity

Trial Design

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 Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor
380 Previous Clinical Trials
628,732 Total Patients Enrolled
4 Trials studying Tobacco Use Disorder
353 Patients Enrolled for Tobacco Use Disorder
Brett Froeliger, PhDPrincipal Investigator - University of Missouri-Columbia
Medical University of South Carolina

Media Library

Clavulanic Acid (Beta-lactamase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03713424 — Phase 2
Tobacco Use Disorder Research Study Groups: Clav, Placebo
Tobacco Use Disorder Clinical Trial 2023: Clavulanic Acid Highlights & Side Effects. Trial Name: NCT03713424 — Phase 2
Clavulanic Acid (Beta-lactamase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03713424 — Phase 2
~4 spots leftby Dec 2025
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