Transfer From Methadone to Buprenorphine Maintenance Treatment Using Buprenorphine Patches
Information source: Psychiatric University Hospital, Zurich
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heroin Addiction
Intervention: Buprenorphine patch and sublingual tablets (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Psychiatric University Hospital, Zurich Official(s) and/or principal investigator(s):
Rudolf Stohler, MD, Study Director, Affiliation: Psychiatric University Hospital
Lukas Boesch, PhD, Study Chair, Affiliation: Psychiatirc University Hospital
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.
Clinical Details
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 design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Short Opiate Withdrawal Scale
Secondary outcome: Heroin use
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Psychiatric University Hospital, Zurich 8032, Switzerland; Recruiting
Melanie Hess, med. pract., Phone: 0041 44 384 21 11, Email: melanie.hess@puk.zh.ch
Rudolf Stohler, MD, Phone: 0041 44 205 58 00, Email: rudolf.stohler@puk.zh.ch
Melanie Hess, med. pract., Principal Investigator
Additional Information
Starting date: August 2008
Ending date: May 2009
Last updated: September 9, 2008
|
