Transfer From Methadone to Buprenorphine Maintenance Treatment Using Buprenorphine Patches

September 9, 2008 updated by: Psychiatric University Hospital, Zurich

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8032
        • Recruiting
        • Psychiatric University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Melanie Hess, med. pract.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Short Opiate Withdrawal Scale
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Heroin use
Time Frame: 60 days
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Psychiatric University Hospital, Zurich

Investigators

  • Study Director: Rudolf Stohler, MD, Psychiatric University Hospital
  • Study Chair: Lukas Boesch, PhD, Psychiatirc University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Anticipated)

February 1, 2009

Study Completion (Anticipated)

May 1, 2009

Study Registration Dates

First Submitted

September 9, 2008

First Submitted That Met QC Criteria

September 9, 2008

First Posted (Estimate)

September 10, 2008

Study Record Updates

Last Update Posted (Estimate)

September 10, 2008

Last Update Submitted That Met QC Criteria

September 9, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-54/2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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