Transfer From Methadone to Buprenorphine Maintenance Treatment Using Buprenorphine Patches

NCT00750217 | Unknown Phase 4 DMC

• 1 other identifier: E-54/2007
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Heroin Addiction

Keywords

transfer methadone buprenorphine patch heroin addiction

Outcome Measures

Primary Outcomes (1)

• Short Opiate Withdrawal Scale

  14 days

Secondary Outcomes (1)

• Heroin use

  60 days

Interventions

Buprenorphine patch and sublingual tablets DRUG

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.

Also known as: Transtec (buprenorphine patch), Subutex (buprenorphine sublingual tablets)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Psychiatric University Hospital, Zurich: lead

Study Sites (1)

Psychiatric University Hospital

Zurich, Canton of Zurich, 8032, Switzerland

RECRUITING

MeSH Terms

Conditions

Heroin Dependence

Interventions

Administration, Sublingual; Buprenorphine

Condition Hierarchy (Ancestors)

Opioid-Related Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Administration, Oral; Drug Administration Routes; Drug Therapy; Therapeutics; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Rudolf Stohler, MD

  Psychiatric University Hospital

  STUDY DIRECTOR

• Lukas Boesch, PhD

  Psychiatirc University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2008
• First Posted: September 10, 2008
• Study Start: August 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: May 1, 2009
• Last Updated: September 10, 2008

Record last verified: 2008-08

Locations

CH (1)