An fMRI Study of the Effects of Clavulanic Acid on Drug Addiction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-26

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Tobacco Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Clav

4-day 125 bid oral capsule administration

Group Type ACTIVE_COMPARATOR

Clavulanic Acid

Intervention Type DRUG

Beta lactamase inhibitor for smoking cessation

Placebo

4-day, twice-daily oral capsule administration

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

placebo

Interventions

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Clavulanic Acid

Beta lactamase inhibitor for smoking cessation

Intervention Type DRUG

Placebo oral capsule

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes