Clavulanic Acid for the Treatment of Cocaine Use Disorder

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

A dose escalation study to assess the efficacy and safety of Clavulanic Acid (CLAV) vs. placebo (PBO) for the treatment of cocaine use disorder (CUD)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Temple University
• Collaborators: Medical University of South Carolina; Research Foundation for Mental Hygiene, Inc.; University of Pennsylvania Perelman School of Medicine
• Treatments: Clavulanic Acid; Clavulanic Acids

Criteria

Inclusion Criteria:

• Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures

• Be male or female adult volunteers ages 18-70 inclusive.

• Have a DSM-V diagnosis of cocaine use disorder, moderate to severe in early remission with a duration of regular (weekly or more) cocaine (either snorted, smoked or injected) for at least one year.

• 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:

• Meets DSM-V criteria for dependence on any substance other than cocaine and mild to moderate alcohol or marijuana (except nicotine or caffeine), determined by the structured clinical interview for DSM-V.

• Allergy to clavulanic acid, penicillin, or any beta-lactam drug.

• Meets current or lifetime DSM-V criteria for schizophrenia or any psychotic disorder or organic mental disorder. Subject meets current DSM-V diagnosis of any other clinically significant psychiatric disorder that will interfere with study participation.

• Severe physical or medical illnesses such as AIDS or active hepatitis.

• If female, tests positive on a pregnancy test, is contemplating pregnancy in the next 6 months, is nursing, or is not using an effective contraceptive method (if relevant)