MedDataX Logo

Transfer From Methadone to Buprenorphine Maintenance Treatment Using Buprenorphine Patches

NCT ID: NCT00750217

Last Updated: 2008-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heroin Addiction

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

transfer methadone buprenorphine patch heroin addiction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Transtec (buprenorphine patch) Subutex (buprenorphine sublingual tablets)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Psychiatric University Hospital, Zurich

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Psychiatric University Hospital, Zurich

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rudolf Stohler, MD

Role: STUDY_DIRECTOR

Psychiatric University Hospital

Lukas Boesch, PhD

Role: STUDY_CHAIR

Psychiatirc University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Psychiatric University Hospital

Zurich, Canton of Zurich, Switzerland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Melanie Hess, med. pract.

Role: primary

Rudolf Stohler, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

E-54/2007

Identifier Type: -

Identifier Source: org_study_id