Transfer From Methadone to Buprenorphine Maintenance Treatment Using Buprenorphine Patches

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2008 by Psychiatric University Hospital, Zurich. Recruitment status was Recruiting

First Received on September 9, 2008. No Changes Posted

Sponsor:	Psychiatric University Hospital, Zurich
Information provided by:	Psychiatric University Hospital, Zurich
ClinicalTrials.gov Identifier:	NCT00750217

Purpose

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	Intervention	Phase
Heroin Addiction	Drug: Buprenorphine patch and sublingual tablets	Phase IV

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Heroin

Drug Information available for: Buprenorphine Buprenorphine hydrochloride Methadone Methadone hydrochloride

U.S. FDA Resources

Further study details as provided by Psychiatric University Hospital, Zurich:

Primary Outcome Measures:

Short Opiate Withdrawal Scale [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Heroin use [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
Study Start Date:	August 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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)

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750217

Locations

Switzerland
Psychiatric University Hospital	Recruiting
Zurich, Switzerland, 8032
Contact: Melanie Hess, med. pract. 0041 44 384 21 11 melanie.hess@puk.zh.ch
Contact: Rudolf Stohler, MD 0041 44 205 58 00 rudolf.stohler@puk.zh.ch
Principal Investigator: Melanie Hess, med. pract.

Sponsors and Collaborators

Psychiatric University Hospital, Zurich

Investigators

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

More Information

No publications provided

Responsible Party:	Stohler Rudolf MD, Psychiatric University Hospital, Zurich
ClinicalTrials.gov Identifier:	NCT00750217 History of Changes
Other Study ID Numbers:	E-54/2007
Study First Received:	September 9, 2008
Last Updated:	September 9, 2008
Health Authority:	Switzerland: Swissmedic

Keywords provided by Psychiatric University Hospital, Zurich:

transfer methadone buprenorphine patch heroin addiction

Additional relevant MeSH terms:

Heroin Dependence
Behavior, Addictive
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Compulsive Behavior
Impulsive Behavior
Buprenorphine
Methadone
Analgesics, Opioid
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on February 09, 2012