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

Temple University

Status and phase: Completed; Phase 1

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

Treatments: Drug: Clavulanic Acid

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03986762

25506

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

9 participants in 1 patient group

Open Label Clav

Experimental group

Treatment:

Drug: Clavulanic Acid