Transfer From Methadone to Buprenorphine Maintenance Treatment Using Buprenorphine Patches

Heroin Addiction Clinical Trial

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.

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00750217
• Other study ID #: E-54/2007
• Status: Unknown status
• Phase: Phase 4
• First received: September 9, 2008
• Last updated: September 9, 2008
• Start date: August 2008
• Est. completion date: May 2009

Study information

• Verified date: August 2008
• Source: Psychiatric University Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 10
• Est. completion date: May 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Addictive
• Heroin Addiction
• Heroin Dependence

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Switzerland	Psychiatric University Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Psychiatric University Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short Opiate Withdrawal Scale		14 days
Secondary	Heroin use		60 days