Overview

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

Status:
Recruiting

Trial end date:
2022-03-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Temple University

Collaborators:

Beth Israel Deaconess Medical Center
University of Pennsylvania Perelman School of Medicine

Treatments:

Clavulanic Acid
Clavulanic Acids

Criteria

Inclusion Criteria:

1. Be able to verbalize understanding of consent form

2. Be male or female adult volunteers ages 18-65 inclusive.

3. Have a DSM-5 diagnosis of cocaine use disorder, moderate to severe in early remission

4. 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.)

5. 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:

1. Have a current DSM-V 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 UDS. Alcohol use disorder and marijuana use disorder, mild without
withdrawal symptoms, will be permitted.

2. Have any previous medically adverse reaction to CLAV, Augmentin, penicillin,
Ticarcillin, cephalosporin, or any beta-lactam drug.

3. 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.

4. Report having human immunodeficiency virus (HIV) infection or test positive for HIV
during screening

5. Be pregnant (females).

6. Unable to tolerate MRI scan for duration of 60 minutes for physical or psychological
reasons.