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Buprenorphine/Naloxone in the Treatment of Heroin Dependence - 14

This study has been completed.
New York MDRU
Information provided by:
National Institute on Drug Abuse (NIDA) Identifier:
First received: April 18, 2001
Last updated: August 17, 2016
Last verified: August 2016
The purpose of this study is the safety and efficacy of Buprenorphine/Naloxone in the treatment of opioid dependence. A compassionate use study.

Condition Intervention Phase
Opioid Dependence
Substance-Related Disorders
Drug: Buprenorphine/naloxone
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Buprenorphine/Nx Treatment of Heroin Dependence-A Compassionate Use Study

Resource links provided by NLM:

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Craving
  • Retention
  • Opioid withdrawal
  • Subjective rating

Enrollment: 582
Study Start Date: August 1999
Study Completion Date: September 2001
Primary Completion Date: August 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Buprenorphine/Naloxone Drug: Buprenorphine/naloxone

Detailed Description:
The objective of this study is to provide follow-up compassionate use treatment and evaluate long term safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment for subjects who have completed Cooperative Study 1008 A and B.

Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

- Completion of Cooperative Study 1008 A/B

Exclusion Criteria:

- Significant medical or psychiatric illness. Non-compliance with study procedures in the Cooperative Study 1008 A/B

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00015340

United States, California
University of California
Los Angeles, California, United States, 90095
United States, Florida
VA Medical Center
Tampa, Florida, United States, 33612
United States, Illinois
VA Medical Center
Hines, Illinois, United States, 60141
United States, New York
New York VAMC
New York, New York, United States, 10010
United States, Washington
VA PUget Sound Helath Care System
Seattle, Washington, United States, 98108
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
New York MDRU
Study Chair: Paul Casadonte, M.D. New York VAMC
  More Information Identifier: NCT00015340     History of Changes
Other Study ID Numbers: NIDA-5-0013-14  Y01-5-0013-14 
Study First Received: April 18, 2001
Last Updated: August 17, 2016
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
Opioid Dependence

Additional relevant MeSH terms:
Substance-Related Disorders
Opioid-Related Disorders
Heroin Dependence
Chemically-Induced Disorders
Mental Disorders
Buprenorphine, Naloxone Drug Combination
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists processed this record on October 20, 2016