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Transfer From Methadone to Buprenorphine Maintenance Treatment Using Buprenorphine Patches

Primary Purpose

Heroin Addiction

Status

Unknown status

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

Buprenorphine patch and sublingual tablets

About this trial

This is an interventional treatment trial for Heroin Addiction focused on measuring transfer methadone buprenorphine patch heroin addiction

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Psychiatric University HospitalRecruiting

Outcomes

Primary Outcome Measures

Short Opiate Withdrawal Scale

Secondary Outcome Measures

Heroin use

Full Information

NCT ID

NCT00750217

First Posted

September 9, 2008

Last Updated

September 9, 2008

Sponsor

Psychiatric University Hospital, Zurich

1. Study Identification

Unique Protocol Identification Number

NCT00750217

Brief Title

Transfer From Methadone to Buprenorphine Maintenance Treatment Using Buprenorphine Patches

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 Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Unknown status

Study Start Date

August 2008 (undefined)

Primary Completion Date

February 2009 (Anticipated)

Study Completion Date

May 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Psychiatric University Hospital, Zurich

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heroin Addiction

Keywords

transfer methadone buprenorphine patch heroin addiction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Buprenorphine patch and sublingual tablets

Other Intervention Name(s)

Transtec (buprenorphine patch), Subutex (buprenorphine sublingual tablets)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Short Opiate Withdrawal Scale

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Heroin use

Time Frame

60 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rudolf Stohler, MD

Organizational Affiliation

Psychiatric University Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Lukas Boesch, PhD

Organizational Affiliation

Psychiatirc University Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Psychiatric University Hospital

City

Zurich

ZIP/Postal Code

8032

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Melanie Hess, med. pract.

Phone

0041 44 384 21 11

melanie.hess@puk.zh.ch

First Name & Middle Initial & Last Name & Degree

Rudolf Stohler, MD

Phone

0041 44 205 58 00

rudolf.stohler@puk.zh.ch

First Name & Middle Initial & Last Name & Degree

Melanie Hess, med. pract.

12. IPD Sharing Statement

Learn more about this trial

Transfer From Methadone to Buprenorphine Maintenance Treatment Using Buprenorphine Patches

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