NCT02563769

Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study

Phase 1, Double-Blind, Placebo-Controlled Assessment of Potential Interactions Between Intravenous Cocaine and Clavulanic Acid

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Temple University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, placebo controlled inpatient crossover safety study of 3 doses (250 mg/day, 500 mg/day, 750 mg/day) of CLAV with an intravenous infusion of cocaine 40 mg. Subjects will be non-treatment seeking experienced cocaine dependent adults, ages 18-65 (N=12 completers, 21 estimated to enroll). Subjects will undergo a washout of the study drug for 5 half-lives between study drug administration sessions. The primary objective will be to determine whether there are clinically significant adverse interactions between CLAV (250 mg/day; 500 mg/day; 750 mg/day) and intravenously administered cocaine in healthy, non-treatment seeking adults with cocaine use disorder.

Conditions

• Cocaine Dependence
• Cocaine Addiction
• Cocaine Abuse
• Cocaine-Related Disorders

Interventions

Type	Name	Description
DRUG	Clavulanic acid	Clavulanic acid will be administered orally in 250mg capsules
DRUG	Intravenous cocaine	20/40mg Cocaine will be administered by IV
DRUG	Placebo	Placebo will be administered orally in capsules identical to CLAV and be filled with crystalline microcellulose

Timeline

• Start date: 2016-10-24
• Primary completion: 2018-05-25
• Completion: 2018-05-25
• First posted: 2015-09-30
• Last updated: 2023-11-03
• Results posted: 2023-11-03

Locations

1 site across 1 country: United States