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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)

Tracking Information
First Submitted Date  ICMJE September 20, 1999
First Posted Date  ICMJE September 21, 1999
Last Update Posted Date January 12, 2017
Study Start Date  ICMJE September 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2005)
  • Physiological effects
  • Analog rating scale for drug effects
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00000243 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals Who Are Maintained on Methadone
Official Title  ICMJE Transitioning Patients From Methadone to Buprenorphine/Naloxone for Treating Opioid Dependence
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.
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  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Opioid-Related Disorders
Intervention  ICMJE Drug: Buprenorphine
Study Arms Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: August 23, 2005)
16
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
154
Study Completion Date January 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Meets criteria for opioid dependence

Exclusion Criteria:

  • Significant medical or psychiatric illness
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000243
Other Study ID Numbers  ICMJE NIDA-08045-1
R01-08045-1
DPMC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Institute on Drug Abuse (NIDA)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric C. Strain, MD Johns Hopkins University
PRS Account National Institute on Drug Abuse (NIDA)
Verification Date November 2016

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