Actively Recruiting
An fMRI Study of the Effects of Clavulanic Acid on Drug Addiction
Led by University of Missouri-Columbia · Updated on 2025-10-28
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of clavulanic acid on smoking behavior in adults who smoke cigarettes. The study aims to see if clavulanic acid can reduce smoking compared to a placebo. This research involves adult smokers aged 18 to 65 years and uses brain imaging to explore how the drug affects brain responses related to smoking. Participants will be randomly assigned to receive either clavulanic acid or a placebo in oral capsule form. The treatment lasts for 4 days, with capsules taken twice daily. The study includes a phase where brain activity is measured using functional MRI while participants view smoking-related images and during resting states to assess changes in brain connectivity. Throughout the study, participants will be monitored for changes in smoking habits over 5 days and any side effects reported. They will undergo brain scans and complete assessments to measure brain responses to smoking cues. The study also includes safety monitoring with urine pregnancy tests for females and checks for adherence to tobacco and nicotine abstinence during participation.
CONDITIONS
Brief Title
An fMRI Study of the Effects of Clavulanic Acid on Drug Addiction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years
- Fluent in English
- Functional vision, with glasses or contacts if needed
- Smoke more than 10 cigarettes per day for at least 2 years
- Expired carbon monoxide level of at least 10 ppm at screening
- If female, negative urine pregnancy test
- Agree to avoid all other tobacco and nicotine products during the study
You will not qualify if you...
- Allergy or sensitivity to clavulanic acid or antibiotics
- Past head injury or neurological disorders affecting MRI (such as dementia, brain tumors, epilepsy, Parkinson's disease)
- Physical or intellectual disability preventing completion of assessments
- Any contraindications to MRI
- Use of antidepressants with smoking cessation effects
- Untreated serious medical conditions
- Current or past psychosis
- Electroconvulsive therapy within past 6 months
- Positive pregnancy test, breastfeeding, or blood alcohol over 0.0
- Use of carbamazepine, nitroglycerin, or other hazardous medications with clavulanic acid within 14 days
- Abnormal liver or kidney function based on blood tests
- Any other condition that may affect safety or study results as judged by the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 days
Participants take Clavulanic Acid or placebo capsules twice daily for 4 days.
Daily visits or assessments during the 4-day treatment period
Duration - 5 days
Participants complete assessments including self-reported side effects and smoking behavior for 5 days.
1 visit after treatment and daily self-reporting for 5 days
Trial Site Locations
Total: 1 location
1
University of Missouri - Columbia
Columbia, Missouri, United States, 65211
Actively Recruiting
Research Team
M
Madhura Athreya, MS
B
Brett E Froeliger, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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