Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study



Status:Completed
Conditions:Psychiatric, Psychiatric, Psychiatric, Psychiatric, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:7/12/2018
Start Date:September 2016
End Date:May 25, 2018

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.


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.)
We found this trial at
1
site
Temple University Hospital - Episcopal Campus
Philadelphia, Pennsylvania 19125
Principal Investigator: Mary F. Morrison, M.D., M.S.
Phone: 215-707-8688
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mi
from
Philadelphia, PA
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