← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am between 18 and 65 years old.
Select...
I agree not to use any tobacco or nicotine products during the study.
Select...
I have provided a negative pregnancy test result.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cigarette Smoking
Self Reported Side Effects
Secondary outcome measures
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
360 Previous Clinical Trials
627,934 Total Patients Enrolled
3 Trials studying Tobacco Use Disorder
323 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What ailment does Clav usually address?

"Clav can be used to fight off enterobacter cloacae, tonsillitis, and gonorrhoea."

Answered by AI

How many individuals can join this research project?

"The listing on clinicaltrials.gov says that this study is open and recruiting patients right now. The trial was first posted on March 26th, 2019 with the most recent update being May 19th, 2022. So far, 30 people have been enrolled at the single site location."

Answered by AI

Are there Clav any long-term side effects?

"Clav's safety is estimated to be a 2. As this is only a Phase 2 trial, there is data suggesting that Clav is safe, but not yet any evidence that it is effective."

Answered by AI

Are there similar studies that have used Clav?

"There are a total of 21 studies currently underway for Clav. Out of these, 5 are in the critical Phase 3 stage. The majority of research centres conducting these studies are based in Chicago, Illinois; however, there are 394 locations running trials for Clav across the world."

Answered by AI

Does this research project have an age limit?

"For this specific study, only patients aged 18 to 65 can apply. In contrast, there are 93 clinical trials for people under the age of 18 and 347 for patients over 65."

Answered by AI

Are we looking for more participants in this experiment?

"That is correct. The listing on clinicaltrials.gov specifies that the research team is still looking for 30 subjects at a single study site. This trial was first posted on March 26th, 2019 and received its latest update on May 19th, 2020."

Answered by AI

How can I sign up to be a part of this research opportunity?

"Up to 30 individuals that struggle with tobacco addiction and meet the age requirements of 18-65 years old can enroll in this trial. Key inclusion criteria for participants include: a willingness to abstain from all other nicotine products for the entirety of the study, functional vision, and meeting the age requirement."

Answered by AI
~2 spots leftby Aug 2024