CompletedPhase 1

Pharmaco-Magnetic Resonance Spectroscopy (MRS) Study of Clavulanic Acid

United States13 participantsStarted 2020-09-01

Plain-language summary

A dose-escalation study to determine the optimum dose of Clavulanic Acid (CLAV) for effects on craving and efficacy.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Be able to verbalize understanding of consent form
✓. Be male or female adult volunteers ages 18-65 inclusive.
✓. Have a Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of cocaine use disorder, moderate to severe in early remission
✓. Have a Body Mass Index (BMI) of 17.5 to 39.9 kg/m2; and a total body weight of at least 45 kg (99 lbs.)
✓. Have a history and brief physical examination that demonstrate no clinically significant contraindication for participating in the study, and/ or significant or unstable medical or psychiatric illness.

Exclusion criteria

✕. Have a current DSM-5 substance use disorder, mild, moderate, or severe, on any drug of abuse other than nicotine, caffeine, and cocaine use disorder in early remission verified by Urine Drug Screen (UDS). Alcohol use disorder and marijuana use disorder, mild without withdrawal symptoms, will be permitted.
✕. Have any previous medically adverse reaction to CLAV, Augmentin, penicillin, Ticarcillin, cephalosporin, or any beta-lactam drug.
✕. Have any illness, condition, and use of medications, in the opinion of the principal investigator, sub-investigators which would preclude safe and/or successful completion of the study.
✕. Report having human immunodeficiency virus (HIV) infection or test positive for HIV during screening
✕. Be pregnant (females).
✕. Unable to tolerate MRI scan for duration of 60 minutes for physical or psychological reasons.

What they're measuring

Brain Glutamate Concentration in the Anterior Cingulate Cortex (ACC) in Subjects With Cocaine Use Disorder (CUD) Treated With Escalating Doses of Clavulanate (CLAV)

Timeframe: ACC glutamate and CCQ will be measured and correlated on Day 10 of treatment with CLAV compared with baseline.

Trial details

NCT IDNCT04411914

SponsorTemple University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-23

Results submitted2023-01-20

View on ClinicalTrials.gov More Cocaine Dependence trials