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Trial record 56 of 186 for:    BUPRENORPHINE AND NALOXONE

Buprenorphine and Naloxone for the Treatment of Opiate Dependence - 1

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. Identifier: NCT00015171
Recruitment Status : Completed
First Posted : April 18, 2001
Last Update Posted : January 16, 2017
New York MDRU
Information provided by:
National Institute on Drug Abuse (NIDA)

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

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

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 0 participants
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: CS1008 A&B Eff/Safety Trial of BUP/NX for the Treatment of Opiate Dependence
Study Start Date : April 1996
Actual Primary Completion Date : May 1997
Actual Study Completion Date : June 1997

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Craving
  2. Drug use
  3. Retention
  4. Opioid withdrawal
  5. 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:   No

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

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 identifier (NCT number): NCT00015171

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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
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Principal Investigator: John Rotrosen, M.D. New York MDRU

Layout table for additonal information Identifier: NCT00015171     History of Changes
Other Study ID Numbers: NIDA-5-0013-1
First Posted: April 18, 2001    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: January 1999
Keywords provided by National Institute on Drug Abuse (NIDA):
opioid dependence
Additional relevant MeSH terms:
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Buprenorphine, Naloxone Drug Combination
Substance-Related Disorders
Opioid-Related Disorders
Heroin Dependence
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists