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Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study

NCT02563769 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-11-03

Study results available
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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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • University of Pennsylvania

    collaborator OTHER

  • Temple University

    lead OTHER

Principal Investigators

  • Kyle M. Kampman, M.D. · U54 Principal Investigator - University of Pennsylvania

  • Mary F. Morrison, M.D., M.S. · Temple University

  • M. I Walters, M.D. · Temple University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-10-24
Primary Completion
2018-05-25
Completion
2018-05-25

Countries

  • United States

Study Locations

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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 NCT02563769 on ClinicalTrials.gov