Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study

• Status: Completed
• Trial end date: 2018-05-25
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to determine if it is safe to use the study drug, clavulanic acid, in combination with cocaine. In this study, subjects will receive intravenous (i.v.) cocaine and the study drug, clavulanic acid. The safety of clavulanic acid is being studied so future studies can be done to find out if this drug is helpful in treating cocaine dependence. Currently, there is no available medication treatment for cocaine dependence.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Temple University
• Collaborators: National Institute on Drug Abuse (NIDA); University of Pennsylvania
• Treatments: Clavulanic Acid; Clavulanic Acids; Cocaine

Criteria

Inclusion Criteria:

• Meet DSM-5 criteria for cocaine use disorder, moderate to severe.

• Be a non-treatment seeking cocaine user.

• If female and of childbearing potential, must have a negative pregnancy test within 48 hours of beginning the study and be willing to use acceptable contraception or be abstinent for 14 days prior to study, through the entire study and 30 days after study participation.

Exclusion Criteria:

• Be seeking treatment for substance abuse.

(For full inclusion/exclusion criteria or for more information, please contact the site directly.)