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Effect of Zonisamide on Cocaine Reinforcement, Craving, and Relapse

NCT01137890 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2017-09-05

Study results available
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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.

Conditions

  • Cocaine Dependence

Interventions

DRUG

Zonisamide

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

DRUG

Placebo

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

DRUG

Cocaine Hydrochloride

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

BEHAVIORAL

Neurocognitive and Performance Battery

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

BEHAVIORAL

Smoking Assessments

Participants answer questions about smoking and smoking behaviors are monitored.

Sponsors & Collaborators

Principal Investigators

  • Annie Umbricht, M.D. · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-03-31
Completion
2013-08-31

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 NCT01137890 on ClinicalTrials.gov