CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 10 enrolled
Drug / intervention
Clavulanic acid +2 moredrug
Likely dose
Clavulanic acid 250mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02563769
NCT02563769Phase 1Completed
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Phase 1, Double-Blind, Placebo-Controlled Assessment of Potential Interactions Between Intravenous Cocaine and Clavulanic Acid

Temple University·interventional·Posted Sep 30, 2015·Updated Nov 3, 2023

In Brief

A Phase 1 clinical trial evaluating Clavulanic acid, Intravenous cocaine, and 1 other intervention for Cocaine Dependence and 3 related conditions. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCocaine Dependence, Cocaine Addiction, Cocaine Abuse, Cocaine-Related Disorders
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA), University of Pennsylvania

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 30, 2015
Enrollment StartOct 24, 2016
Primary CompletionMay 25, 2018
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.8 years ago

Interventions

Clavulanic aciddrug

Clavulanic acid will be administered orally in 250mg capsules

Intravenous cocainedrug

20/40mg Cocaine will be administered by IV

Placebodrug

Placebo will be administered orally in capsules identical to CLAV and be filled with crystalline microcellulose