Buprenorphine/Naloxone in the Treatment of Heroin Dependence - 14

This study has been completed.

First Received: April 18, 2001 Last Updated: August 26, 2008 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Collaborator:	New York MDRU
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00015340

Purpose

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 III

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:

MedlinePlus related topics: Heroin

Drug Information available for: Buprenorphine Buprenorphine hydrochloride Naloxone hydrochloride Naloxone Diacetylmorphine Diacetylmorphine hydrochloride

U.S. FDA Resources

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.

Eligibility

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

Criteria

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

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

Locations

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

Investigators

Principal Investigator:

Paul Casadonte, M.D.

New York VAMC

More Information

No publications provided

Study ID Numbers:	NIDA-5-0013-14, Y01-5-0013-14
Study First Received:	April 18, 2001
Last Updated:	August 26, 2008
ClinicalTrials.gov Identifier:	NCT00015340 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Heroin Dependence
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Narcotics
Opioid-Related Disorders
Pharmacologic Actions
Naloxone

Buprenorphine
Mental Disorders
Sensory System Agents
Therapeutic Uses
Substance-Related Disorders
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on March 18, 2010