Clavulanic Acid for Quitting Smoking
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether clavulanic acid can help reduce smoking habits. Participants will receive either clavulanic acid or a placebo (a pill with no active ingredient) to determine any noticeable difference in smoking behavior. The trial targets adults who have smoked more than 10 cigarettes a day for over two years. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
You may need to stop taking certain medications, especially if they are antidepressants used for quitting smoking or if they include carbamazepine or nitroglycerin. It's best to discuss your current medications with the study team to see if they are allowed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that clavulanic acid has been studied for various uses. The FDA has approved it for treating certain infections when combined with antibiotics, indicating its relative safety for humans. In other studies, researchers tested clavulanic acid for different conditions, and participants generally tolerated it well, with no major safety issues reported. While mild side effects may occur, serious problems are rare. Overall, existing evidence suggests that clavulanic acid is likely safe for humans, but discussing any concerns with a healthcare provider remains important.12345
Why do researchers think this study treatment might be promising?
Most treatments for quitting smoking involve nicotine replacement therapies or medications like varenicline and bupropion, which target nicotine receptors or affect neurotransmitter levels in the brain. However, clavulanic acid is unique because it is traditionally used as a beta-lactamase inhibitor in antibiotic treatments, not for smoking cessation. Researchers are excited about clavulanic acid because it may offer a novel approach by potentially altering brain pathways related to addiction differently than existing therapies. This could provide an effective alternative for those who have not succeeded with standard options.
What evidence suggests that clavulanic acid might be an effective treatment for quitting smoking?
This trial will compare clavulanic acid with a placebo to evaluate its potential to help people quit smoking. Research has suggested that clavulanic acid might reduce smoking more effectively than a placebo. It may work in the brain to affect cravings or habits related to smoking. As this is still under study, most information comes from early research. However, it shows potential as a helpful tool for quitting smoking.678910
Who Is on the Research Team?
Brett Froeliger, PhD
Principal Investigator
University of Missouri-Columbia
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either clavulanic acid or placebo for 4 days, with twice-daily oral capsule administration
Follow-up
Participants are monitored for safety and effectiveness after treatment, including fMRI and biochemical assessments
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
4-day 125 bid oral capsule administration
4-day, twice-daily oral capsule administration
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Missouri-Columbia
Lead Sponsor
Citations
An fMRI Study of the Effects of Clavulanic Acid on Drug ...
The primary study hypothesis is that, compared to placebo, clavulanic acid will reduce smoking over the course of the study.
An fMRI Study of the Effects of Clavulanic Acid on Drug ...
The primary study hypothesis is that, compared to placebo, clavulanic acid will reduce smoking over the course of the study.
three years results of a smoking cessation clinic - PMC
In the current study, NRT was significantly more effective than varenicline based on patients' smoking cessation rates at one year (32.5% vs. ...
A Review of Smoking Cessation Interventions - PubMed Central
Moreover, attempting to quit smoking without any structured approach yielded a mere 3%-5% success rate within the same timeframe [7]. This study ...
5.
tobaccopreventioncessation.com
tobaccopreventioncessation.com/Cytisine-for-smoking-cessation-A-40-day-treatment-with-an-induction-period,187556,0,2.htmlCytisine for smoking cessation: A 40-day treatment with an ...
The reported cessation rates were 50.5%, 55.9%, and 51.0%, respectively, in the cytisine (40 days), varenicline (12 weeks), and NRT (8 weeks) ...
Ongoing Studies | College of Medicine | MUSC
A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study to Assess the Efficacy and Safety of Clavulanic Acid vs. Placebo for the Treatment of Cocaine ...
Pharmacologic agents for smoking cessation: A clinical review
With pharmacotherapy the estimated 6-month abstinence rate is about 20%, whereas it is about 10% without pharmacotherapy. The first-line of ...
Public Health Impact of FDA's Request for Additional Safety ...
In a mathematical model, making cytisine available immediately could lead approximately 71 000 more people to quit smoking over 1 year and ...
Smoking Cessation Medications: Efficacy, Mechanisms ...
This research study will last for three years. The first year involves a comparison of smoking cessation medications (bupropion, nicotine patch, ...
A New Medication for Smoking Cessation?
In a recent phase 3 trial of cytisinicline versus placebo, the drug was well tolerated and effective for smoking cessation (JAMA 2023; 330:152) ...
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