Clavulanic Acid for the Treatment of Cocaine Use Disorder (NCT05562349) | Clinical Trial Compass
UnknownPhase 2
Clavulanic Acid for the Treatment of Cocaine Use Disorder
United States65 participantsStarted 2023-05-03
Plain-language 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)
Who can participate
Age range18 Years – 70 Years
SexALL
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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)
What they're measuring
1
Changes in relapse to cocaine use in CLAV group vs PBO group