NCT05562349

Clavulanic Acid for the Treatment of Cocaine Use Disorder

A Randomized, Double-Blind, Placebo-Controlled Phase 2a Pilot Study to Assess the Efficacy and Safety of Clavulanic Acid vs. Placebo for the Treatment of Cocaine Use Disorder

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Temple University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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)

Detailed description

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.

Conditions

• Cocaine Dependence

Interventions

Type	Name	Description
DRUG	Clavulanic Acid Only Product	Drug will be given in 250mg capsules
DRUG	Placebo	Capsule with no active medication - identical to drug capsule

Timeline

• Start date: 2023-05-03
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2022-09-30
• Last updated: 2024-05-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study