Transfer From Methadone to Buprenorphine Maintenance Trea... | NCT00750217

Studies
Transfer From Methadone to Buprenorphine Maintenance Treatment Using Buprenorphine Patches

NCT00750217

Sponsor

Psychiatric University Hospital, Zurich

Status

Unknown status

Last Update Posted

Sep 10, 2008Estimated

Enrollment

10Estimated

Phase

Phase 4

Conditions

Heroin Addiction

Interventions

Buprenorphine patch and sublingual tablets

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Feb 2009Estimated

Completion Date

May 2009Estimated

First Submitted Date

Sep 9, 2008

First Submission Date that Met QC Criteria

Sep 9, 2008

First Posted Date

Sep 10, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2008

Last Update Posted Date

Sep 10, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.		Transtec (buprenorphine patch) Subutex (buprenorphine sublingual tablets)

Measure	Description	Time Frame
Short Opiate Withdrawal Scale		14 days

Measure	Description	Time Frame
Heroin use		60 days

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rudolf Stohler, MD	Psychiatric University Hospital	Study Director
Lukas Boesch, PhD	Psychiatirc University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Psychiatric University Hospital	Recruiting	Zurich	Canton of Zurich	8032	Switzerland

Type	Date	Date Unknown
Release	Sep 23, 2010
Reset	Oct 19, 2010

Submission Tracking

Estimated Results First Submitted Date

Sep 23, 2010

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Sep 23, 2010			Oct 19, 2010

Condition Browse Module

MeSH Terms

ID	Term
D006556	Heroin Dependence

Ancestor Terms

ID	Term
D009293	Opioid-Related Disorders
D000079524	Narcotic-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000286	Administration, Sublingual
D002047	Buprenorphine

Ancestor Terms

ID	Term
D000284	Administration, Oral
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided