CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
Zonisamide +4 moredrug
Likely dose
Not stated in 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/NCT01137890
NCT01137890Phase 2Completed
CompareCT.gov

Effect of Zonisamide on Cocaine Reinforcement, Craving, and Relapse

Johns Hopkins University·interventional·Posted Jun 7, 2010·Updated Sep 5, 2017

In Brief

A Phase 2 clinical trial evaluating Zonisamide, Placebo, and 3 other interventions for Cocaine Dependence. Completed, enrolled 19 participants across 1 site.

Detailed Summary

This is a residential pilot trial to evaluate the pharmacodynamic interaction between zonisamide and cocaine, with the goal of evaluating zonisamide's potential for the treatment of cocaine dependence.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCocaine Dependence
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 7, 2010
Enrollment StartJun 1, 2010
Primary CompletionMar 1, 2012
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.1 years ago

Interventions

Zonisamidedrug

Eight capsules administered daily in split doses at 22:00 and 09:00.

Placebodrug

capsules administered in split doses at 22:00 and 09:00.

Cocaine Hydrochloridedrug

Cocaine Challenge Sessions: Human laboratory sessions with administration of moderate doses of cocaine by the intravenous route under controlled conditions and cardiovascular monitoring.

Neurocognitive and Performance Batterybehavioral

Participants will complete tests to assess their abilities and performances on a number of tasks given by a computer or other type of equipment.

Smoking Assessmentsbehavioral

Participants answer questions about smoking and smoking behaviors are monitored.