Overview

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

Status:
Completed
Trial end date:
2019-12-20
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Temple University
Collaborator:
National Institute on Drug Abuse (NIDA)
Treatments:
Clavulanic Acid
Clavulanic Acids
Criteria
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.)