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VIVITROL as a Treatment for Cocaine and Alcohol Dependence

NCT00777062 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-01-26

Study results available
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Summary

To evaluate the efficacy of VIVITROL (naltrexone for extended-release injectable suspension) for the treatment of co-occurring cocaine and alcohol dependence

Conditions

  • Cocaine Dependence
  • Alcohol Dependence

Interventions

DRUG

VIVITROL (Naltrexone extended-release injectable suspension)

VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6.

DRUG

Placebo

Placebo injection at the start of weeks 2 and 6.

Sponsors & Collaborators

  • Alkermes, Inc.

    collaborator INDUSTRY

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • University of Pennsylvania

    lead OTHER

Principal Investigators

  • Helen Pettinati, Ph.D. · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-07-31
Completion
2013-09-30

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 NCT00777062 on ClinicalTrials.gov