Clavulanic Acid for the Treatment of Cocaine Use Disorder

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Cocaine Dependence

In brief

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)

Key facts

Study ID

NCT05562349

Run by

Temple University

People needed

65

Starts

2023-05-03

Expected to finish

2024-07-01

Last updated by the study team

2024-05-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 Diagnostic and Statistical Manual (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.

You may not qualify if…

• 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)

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• MUSC — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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