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Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence

NCT01811940 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2019-04-24

Study results available
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Summary

The proposed protocol is a multi-site double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (MAS-ER) and topiramate in the treatment of cocaine dependence. 198 patients will be enrolled and 176 patients randomized in a 14-week trial. The proportion of participants achieving sustained cocaine abstinence for three consecutive weeks at the end of the study will be significantly greater for the combined pharmacotherapies group compared to the placebo group.

Conditions

  • Cocaine Dependence

Interventions

DRUG

Adderall-ER

MAS-ER 60mg/day

DRUG

Topiramate

Topiramate 100 mg bid.

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • Frances Levin, M.D. · Columbia University

  • Kyle Kampman, MD · University of Pennsylvania

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
2013-07-31
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • United States

Study Locations

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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 NCT01811940 on ClinicalTrials.gov