Buprenorphine and Naloxone for the Treatment of Opiate Dependence - 1

This study has been completed.

First Received on April 18, 2001. Last Updated on November 3, 2005 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:	NCT00015171

Purpose

The purpose of this study is the use of buprenorphine/naloxone in treatment of opioid dependence.

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

Study Type:	Interventional
Study Design:	Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	CS1008 A&B Eff/Safety Trial of BUP/NX for the Treatment of Opiate Dependence

Resource links provided by NLM:

MedlinePlus related topics: Drug Abuse Heroin

Drug Information available for: Buprenorphine Buprenorphine hydrochloride Naloxone hydrochloride Naloxone

U.S. FDA Resources

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

Primary Outcome Measures:

Craving
Drug use
Retention
Opioid withdrawal
Subjective rating

Estimated Enrollment:	0
Study Start Date:	April 1996

Detailed Description:

The objective of this study is to determine the safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment.

Eligibility

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

Criteria

Inclusion Criteria:

DSM-IV diagnosis of current opiate dependence males and non-pregnant, non-nursing female 18-59 yrs of age

Exclusion Criteria:

Any significant medical condition AST or ALT levels greater than 3x's the upper limit of normal level Current Axis I diagnosis other than opiate, caffeine or nicotine dependence

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00015171

Locations

United States, New York
New York MDRU
New York, New York, United States, 10010

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

New York MDRU

Investigators

Principal Investigator:

John Rotrosen, M.D.

New York MDRU

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00015171 History of Changes
Other Study ID Numbers:	NIDA-5-0013-1, Y01-5-0013-1
Study First Received:	April 18, 2001
Last Updated:	November 3, 2005
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Heroin Dependence
Substance-Related Disorders
Opioid-Related Disorders
Mental Disorders
Buprenorphine
Naloxone
Analgesics, Opioid
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012