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

Entry criteria:

Inclusion criteria

all subjects:

• 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 criteria

all subjects:

• 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