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Buprenorphine/Naloxone in the Treatment of Heroin Dependence - 14

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00015340
Recruitment Status : Completed
First Posted : April 18, 2001
Last Update Posted : January 12, 2017
Sponsor:
Collaborator:
New York MDRU
Information provided by:
National Institute on Drug Abuse (NIDA)

Brief Summary:
The purpose of this study is the safety and efficacy of Buprenorphine/Naloxone in the treatment of opioid dependence. A compassionate use study.

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 582 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Buprenorphine/Nx Treatment of Heroin Dependence-A Compassionate Use Study
Study Start Date : August 1999
Primary Completion Date : August 2001
Study Completion Date : September 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heroin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Buprenorphine/Naloxone Drug: Buprenorphine/naloxone



Primary Outcome Measures :
  1. Craving
  2. Retention
  3. Opioid withdrawal
  4. Subjective rating


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00015340


Locations
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
Investigators
Study Chair: Paul Casadonte, M.D. New York VAMC

ClinicalTrials.gov Identifier: NCT00015340     History of Changes
Other Study ID Numbers: NIDA-5-0013-14
Y01-5-0013-14
First Posted: April 18, 2001    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: August 2016

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

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