Clavulanic Acid for the Treatment of Cocaine Use Disorder

This pilot study is indicated for treatment of moderate to severe cocaine use disorder. It is a randomized, placebo-controlled, parallel group, multi-center pilot study to compare the efficacy of 500-750mg/day clavulanic acid vs. placebo in addition to weekly medication management therapy. Subjective, cognitive, and adverse effect assessments, blood pressure and pulse will be performed 1-3 times weekly.

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 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.

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)