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Clavulanic Acid for the Treatment of Cocaine Use Disorder

NCT05562349 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2024-05-02

No results posted yet for this study

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)

Conditions

  • Cocaine Dependence

Interventions

DRUG

Clavulanic Acid Only Product

Drug will be given in 250mg capsules

DRUG

Placebo

Capsule with no active medication - identical to drug capsule

Sponsors & Collaborators

  • University of Pennsylvania

    collaborator OTHER

  • Medical University of South Carolina

    collaborator OTHER

  • Research Foundation for Mental Hygiene, Inc.

    collaborator OTHER

  • Temple University

    lead OTHER

Principal Investigators

  • Mary Morrison, MD, MS · Temple University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-03
Primary Completion
2024-07-31
Completion
2024-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05562349 on ClinicalTrials.gov