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

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ClinicalTrials.gov Identifier: NCT00000243
Recruitment Status : Terminated
First Posted : September 21, 1999
Last Update Posted : January 12, 2017
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)

Brief Summary:
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 or disease Intervention/treatment Phase
Opioid-Related Disorders Drug: Buprenorphine Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Transitioning Patients From Methadone to Buprenorphine/Naloxone for Treating Opioid Dependence
Study Start Date : September 2002
Study Completion Date : January 2004

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Physiological effects
  2. Analog rating scale for drug effects


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Meets criteria for opioid dependence

Exclusion Criteria:

  • Significant medical or psychiatric illness

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): 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

ClinicalTrials.gov Identifier: NCT00000243     History of Changes
Other Study ID Numbers: NIDA-08045-1
R01-08045-1
DPMC
First Posted: September 21, 1999    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: November 2016

Keywords provided by National Institute on Drug Abuse (NIDA):
opioid dependence

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