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

Completed · Phase 1

Conditions studied: Cocaine Dependence, in Remission, Cocaine Abuse, in Remission, Cocaine-Related Disorders

In brief

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.

Key facts

Study ID

NCT03986762

Run by

Temple University

People needed

9

Starts

2019-03-12

Expected to finish

2019-12-20

Last updated by the study team

2020-10-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Be unable to complete an MRI scan
• (For full inclusion/exclusion criteria or for more information, please contact the site directly.)

Where it is running

• Episcopal Hospital Medical Arts Building — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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