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An fMRI Study of the Effects of Clavulanic Acid on Drug Addiction
RecruitingPhase 2Healthy volunteers welcome
Who can join
Ages 18 to 65 · All sexes · Healthy volunteers welcome
Full eligibility criteria
Entry criteria: Inclusion Criteria all subjects: 1. Age 18-65 years 2. English fluency 3. Functional vision (with corrective lenses as needed) to complete assigned assessments and tasks 4. 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) 5. If female, provide a negative urine pregnancy test. 6. 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 Exclusion Criteria all subjects: 1. Sensitivity or allergy to clavulanic acid/antibiotics 2. Past head injury or primary neurological disorder associated with MRI abnormalities, including dementia, MCI, brain tumors, epilepsy, Parkinson's disease, or demyelinating diseases 3. Any physical or intellectual disability affecting completion of assessments 4. Any contraindication to MRI 5. Use of antidepressants medications with smoking cessation efficacy 6. Presence of an untreated illness or serious medical condition 7. Current or past psychosis 8. Electroconvulsive therapy in last 6 months 9. Positive pregnancy test (Urine pregnancy testing at screening and prior to fMRI scan) or currently breast feeding or BAC greater than 0.0 10. Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with CLAV) within 14 days of study participation 11. Abnormal liver function determined by Complete Metabolic Panel - liver enzymes outside normal ranges of AST (SGOT) 5-40 unites/L and ALT( SGPT) 7-56units/L 12. Abnormal renal function determined by Complete Metabolic Panel - outside normal ranges of BUN 6-24 mg /dl and Creatinine level 0.6 -1.2 mg /dl male, 0.5-1.1mg /dl female 13. Any other condition or concern that in the investigator's opinion would impact participant safety, compliance with study instructions, or potentially confound the interpretation of the study results
About the study
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.
What is being tested
- Clavulanic Acid (drug)
- Placebo oral capsule (drug)
Sponsor: University of Missouri-Columbia · Participants: 30 · Started: Mar 26, 2019
Contact the study team
- Madhura Athreya, MS · Phone: 573-882-2977
- Brett E Froeliger, PhD · Phone: 573-882-4785
Official record on ClinicalTrials.gov — NCT03713424
Locations in the U.S.
| Missouri | University of Missouri - Columbia, Columbia |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.