Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals Who Are Maintained on Methadone

This study has been terminated.

First Received: September 20, 1999 Last Updated: March 15, 2007 History of Changes

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00000243

Purpose

Buprenorphine is a drug that may be helpful in treating opioid dependent individuals who were previously maintained on methadone. The purpose of this study is to determine the effects of different doses of buprenorphine/naloxone in treating opioid dependent individuals who were previously maintained on methadone.

Condition	Intervention
Opioid-Related Disorders	Drug: Buprenorphine

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Pharmacodynamics Study
Official Title:	Transitioning Patients From Methadone to Buprenorphine/Naloxone for Treating Opioid Dependence

Resource links provided by NLM:

Drug Information available for: Buprenorphine Buprenorphine hydrochloride Methadone Naloxone

U.S. FDA Resources

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

Primary Outcome Measures:

Physiological effects
Analog rating scale for drug effects

Estimated Enrollment:	16
Study Start Date:	September 2002
Estimated Study Completion Date:	January 2004

Detailed Description:

Buprenorphine is a mixed agonist-antagonist opioid that is being developed as a treatment for opioid dependence. Because buprenorphine is a partial mu agonist opioid, under certain conditions it is possible for buprenorphine to precipitate opioid withdrawal in opioid dependent individuals. A person with a high level of physical dependence could experience buprenorphine-related precipitated withdrawal. The purpose of this study is to test the acute effects of different doses of buprenorphine/naloxone in opioid dependent individuals maintained on methadone. The study is designed to provide dosing schedules similar to those that might be initially used in a physician's office.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Meets criteria for opioid dependence

Exclusion Criteria:

Significant medical or psychiatric illness

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000243

Locations

United States, Maryland
Johns Hopkins University (BPRU) Bayview Campus
Baltimore, Maryland, United States, 21224 6823

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Eric C. Strain, MD

Johns Hopkins University

More Information

No publications provided

Study ID Numbers:	NIDA-08045-1, R01-08045-1, DPMC
Study First Received:	September 20, 1999
Last Updated:	March 15, 2007
ClinicalTrials.gov Identifier:	NCT00000243 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Narcotic Antagonists
Disorders of Environmental Origin
Central Nervous System Depressants
Narcotics
Opioid-Related Disorders
Naloxone
Methadone

Buprenorphine
Mental Disorders
Substance-Related Disorders
Analgesics
Peripheral Nervous System Agents
Analgesics, Opioid

Additional relevant MeSH terms:

Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Narcotics
Opioid-Related Disorders
Pharmacologic Actions
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 July 02, 2009