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)
ClinicalTrials.gov Identifier:
First received: April 18, 2001
Last updated: August 26, 2008
Last verified: August 2008
The purpose of this study is the safety and efficacy of Burprenorphine/Naloxone in the treatment of opioid dependence. A compassionate use study.

Condition Intervention Phase
Heroin Dependence
Substance-Related Disorders
Drug: Buprenorphine/naloxone
Phase 3

Study Type: Interventional
Study Design: 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

Estimated Enrollment: 0
Study Start Date: November 1997
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 CS 1008 A and B.

Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

completions of CS 1008 A/B

Exclusion Criteria:

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00015340

United States, New York
New York VAMC
New York, New York, United States, 10010
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
New York MDRU
Principal Investigator: Paul Casadonte, M.D. New York VAMC
  More Information

ClinicalTrials.gov 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 26, 2008
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on July 24, 2016