RecruitingPhase 2NCT03713424

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

Sponsor

University of Missouri-Columbia

Enrollment

30 participants

Start Date

Mar 26, 2019

Study Type

INTERVENTIONAL

Conditions

Tobacco Use Disorder

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria7

Entry criteria:
Age 18-65 years
English fluency
Functional vision (with corrective lenses as needed) to complete assigned assessments and tasks
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)
If female, provide a negative urine pregnancy test.
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 Criteria13

Sensitivity or allergy to clavulanic acid/antibiotics
Past head injury or primary neurological disorder associated with MRI abnormalities, including dementia, MCI, brain tumors, epilepsy, Parkinson's disease, or demyelinating diseases
Any physical or intellectual disability affecting completion of assessments
Any contraindication to MRI
Use of antidepressants medications with smoking cessation efficacy
Presence of an untreated illness or serious medical condition
Current or past psychosis
Electroconvulsive therapy in last 6 months
Positive pregnancy test (Urine pregnancy testing at screening and prior to fMRI scan) or currently breast feeding or BAC greater than 0.0
Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with CLAV) within 14 days of study participation
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
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
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