CompletedPhase 1

Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study

United States10 participantsStarted 2016-10-24

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Meet Diagnostic and Statistical Manual of Mental Disorders Fifth Edition 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.)

What they're measuring

Number of Participants With Severe Adverse Events (AEs)

Timeframe: 6 Days (Study Days 1, 2, 3, 4, 5, 10)

Change in Heart Rate in Response to IV Cocaine Infusion With and Without CLAV Dosing

Timeframe: 4 Days (Study Days 2, 3, 4, 5)

Changes in Blood Pressure in Response to IV Cocaine With and Without CLAV Dosing

Timeframe: 4 Days (Study Days 2, 3, 4, 5)

Electrocardiogram (ECG) Following IV Cocaine With and Without CLAV Dosing

Timeframe: 4 Days (Study Days 2, 3, 4, 5)

Trial details

NCT IDNCT02563769

SponsorTemple University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-05-25

Results submitted2022-08-11

View on ClinicalTrials.gov More Cocaine Dependence trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Severe Adverse Events (AEs)

Timeframe: 6 Days (Study Days 1, 2, 3, 4, 5, 10)

Change in Heart Rate in Response to IV Cocaine Infusion With and Without CLAV Dosing

Timeframe: 4 Days (Study Days 2, 3, 4, 5)

Changes in Blood Pressure in Response to IV Cocaine With and Without CLAV Dosing

Timeframe: 4 Days (Study Days 2, 3, 4, 5)

Electrocardiogram (ECG) Following IV Cocaine With and Without CLAV Dosing

Timeframe: 4 Days (Study Days 2, 3, 4, 5)