Phase
Condition
Tobacco Use Disorder
Stimulant Use Disorder
Opioid Use Disorder
Treatment
Placebo oral capsule
Clavulanic Acid
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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
Study Design
Connect with a study center
University of Missouri - Columbia
Columbia, Missouri 65211
United StatesActive - Recruiting
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
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