CompletedPhase 1

Open Label Pharmaco- Magnetic Resonance Spectrography (MRS) Study of Clavulanic Acid

United States9 participantsStarted 2019-03-12

Plain-language summary

The main purpose of this study is to determine how the study drug, clavulanic acid, affects glutamate in the brain using Magnetic Resonance (MR/MRI) scans. In this study, subjects will receive the study drug, clavulanic acid and undergo 4 MRI scans. This is being studied to determine the correct dosing of clavulanic acid, and to gather data so future studies can be done to find out if this drug is helpful in treating cocaine dependence. Currently, there is no available medication treatment for cocaine dependence.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Meet DSM-5 criteria for cocaine use disorder, moderate to severe in early remission. * Be male or female adult volunteers ages 18-65 inclusive. * If female and of childbearing potential, must have a negative pregnancy test within 48 hours of beginning the study and be willing to use acceptable contraception or be abstinent for 14 days prior to study, through the entire study and 30 days after study participation. Exclusion Criteria: * Be unable to complete an MRI scan (For full inclusion/exclusion criteria or for more information, please contact the site directly.)

What they're measuring

Glutamate change from baseline

Timeframe: 10-17 Days

Glutamate/creatine ratio change from baseline

Timeframe: 10-17 Days

Trial details

NCT IDNCT03986762

SponsorTemple University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-20

View on ClinicalTrials.gov More Cocaine Dependence, in Remission trials