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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)

September 20, 1999
September 21, 1999
January 12, 2017
September 2002
Not Provided
  • Physiological effects
  • Analog rating scale for drug effects
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Complete list of historical versions of study NCT00000243 on ClinicalTrials.gov Archive Site
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Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals Who Are Maintained on Methadone
Transitioning Patients From Methadone to Buprenorphine/Naloxone for Treating Opioid Dependence
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Opioid-Related Disorders
Drug: Buprenorphine
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
154
January 2004
Not Provided

Inclusion Criteria:

  • Meets criteria for opioid dependence

Exclusion Criteria:

  • Significant medical or psychiatric illness
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00000243
NIDA-08045-1
R01-08045-1
DPMC
Not Provided
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National Institute on Drug Abuse (NIDA)
Not Provided
Principal Investigator: Eric C. Strain, MD Johns Hopkins University
National Institute on Drug Abuse (NIDA)
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP