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Transfer From Methadone to Buprenorphine Maintenance Treatment Using Buprenorphine Patches

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: NCT00750217
Recruitment Status : Unknown
Verified August 2008 by Psychiatric University Hospital, Zurich.
Recruitment status was:  Recruiting
First Posted : September 10, 2008
Last Update Posted : September 10, 2008
Information provided by:
Psychiatric University Hospital, Zurich

Brief Summary:
Buprenorphine is an important alternative to methadone in the maintenance treatment of heroin addiction. Transfer from methadone to buprenorphine requires a reduction of daily methadone dosage below 30 mg to avoid withdrawal after the first buprenorphine intake. The study hypothesis states that the transfer from a daily methadone dosage between 60 mg and 100 mg to buprenorphine can be carried out without withdrawal using buprenorphine patches (35 micro grams per hour) within 12 to 48 hours after last methadone intake.

Condition or disease Intervention/treatment Phase
Heroin Addiction Drug: Buprenorphine patch and sublingual tablets Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transfer From Methadone to Buprenorphine Maintenance Treatment Using Buprenorphine Patches: A Study on Practicability With Patients Maintained With Daily Dosages Between 60mg and 100mg Methadone.
Study Start Date : August 2008
Estimated Primary Completion Date : February 2009
Estimated Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heroin

Intervention Details:
  • Drug: Buprenorphine patch and sublingual tablets

    Buprenorphine patch: 35 micro grams per hour 12 to 48 hours after last methadone intake.

    Buprenorphine sublingual tablets: 2mg 48 and 60 hours after last methadone intake; 8mg 72 and 84 hours after last methadone intake; 8mg 96, 102 and 109 hours after last methadone intake.

    Other Names:
    • Transtec (buprenorphine patch)
    • Subutex (buprenorphine sublingual tablets)

Primary Outcome Measures :
  1. Short Opiate Withdrawal Scale [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Heroin use [ Time Frame: 60 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age between 18 and 60 years
  • Methadone maintenance treatment for at least 3 months preceding the study
  • Daily methadone dosage between 60mg amd 100mg
  • Sufficient knowledge of German language
  • Ability to give informed consent

Exclusion Criteria:

  • Daily methadone dosage below 60mg amd over 100mg
  • Prescribed use of benzodiazepines over 30 mg equivalent to diazepam
  • Misuse or dependence of alcohol and/or GHB/GBL
  • Pregnant or breast-feeding women
  • Known intolerance of buprenorphine
  • Somatic diseases interfering with the study plan

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): NCT00750217

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Psychiatric University Hospital Recruiting
Zurich, Switzerland, 8032
Contact: Melanie Hess, med. pract.    0041 44 384 21 11   
Contact: Rudolf Stohler, MD    0041 44 205 58 00   
Principal Investigator: Melanie Hess, med. pract.         
Sponsors and Collaborators
Psychiatric University Hospital, Zurich
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Study Director: Rudolf Stohler, MD Psychiatric University Hospital
Study Chair: Lukas Boesch, PhD Psychiatirc University Hospital
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Responsible Party: Stohler Rudolf MD, Psychiatric University Hospital, Zurich Identifier: NCT00750217    
Other Study ID Numbers: E-54/2007
First Posted: September 10, 2008    Key Record Dates
Last Update Posted: September 10, 2008
Last Verified: August 2008
Keywords provided by Psychiatric University Hospital, Zurich:
transfer methadone buprenorphine patch heroin addiction
Additional relevant MeSH terms:
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Heroin Dependence
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists