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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    30
  • sponsor
    University of Missouri-Columbia
Updated on 2 June 2022
carbon monoxide
addiction
drug dependence
tobacco smoke
smoke tobacco
nicotine product
smoking cessation therapy
Accepts healthy volunteers

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.

Details
Condition Tobacco Use Disorder
Treatment Placebo oral capsule, Clavulanic acid
Clinical Study IdentifierNCT03713424
SponsorUniversity of Missouri-Columbia
Last Modified on2 June 2022

Eligibility

Yes No Not Sure

Inclusion 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 Criteria

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
Current or past psychosis
Use of antidepressants medications with smoking cessation efficacy
Presence of an untreated illness or serious medical condition
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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