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A Placebo-Controlled Study of Mixed Amphetamine Salts and Topiramate for the Treatment of Cocaine Dependence

NCT00421603 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2019-04-24

Study results available
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Summary

The proposed protocol is a double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (ER-MAS) and topiramate in the treatment of cocaine dependence. Since both of these medications have independently shown promise in helping with cocaine abuse we are proposing that together they may be even more successful in the treatment of cocaine abuse. We plan to enroll 120 subjects in a 14-week trial. The primary objective of the study is to determine the efficacy of ER-MAS and topiramate in promoting cocaine abstinence among cocaine-dependent patients. This study includes free treatment for cocaine dependence that includes medication.

Conditions

  • Cocaine Dependence

Interventions

DRUG

Adderall-XR and Topiramate

Adderall-XR 60mg/day and Topiramate 300mg/day

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • Frances R Levin, M.D. · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00421603 on ClinicalTrials.gov