Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (NIS P05444)

Opioid-Related Disorders Clinical Trial

Official title:

Evaluation of Transfer From Subutex or Other Treatment for Opioid Drug Dependence to Suboxone: Acceptability, Safety and Impact on Medication Dispensing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725608
• Other study ID #: P05444
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: April 26, 2012
• Start date: May 2008
• Est. completion date: April 2011

Study information

• Verified date: April 2012
• Source: Indivior Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the acceptability and safety of switching to Suboxone® (buprenorphine plus naloxone) and the effect of the switch on medication dispensing. Subjects, for whom a therapy with Suboxone® is indicated and planned prior to study enrollment and who are willing to participate, will initiate therapy on Day 1 of the study. The dosage will be adjusted between Day 2 to 7 depending on patient's needs and determined by the treating physicians in accordance with the SmPC of Suboxone®. Data will be collected at baseline, day 1 til 7, the end of weeks 2 and 4 and monthly up to the end of Month 12.

Description:

Nonprobability sampling was done by invitation to volunteer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• All patients on substitution therapy, that are willing to switch to Suboxone, can be included.

• Therapeutic indications and contraindications for Suboxone® must be taken into consideration when selecting patients.

Exclusion Criteria:

• According to product information

• In accordance with the product information pregnant women will be excluded.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Drug Abuse
• Opiate Dependence
• Opioid-Related Disorders

Intervention

Drug:
• buprenorphine/naloxone
2/0.5 mg buprenorphine/naloxone and 8/2 mg buprenorphine/naloxone sublingual tablets; dosage and frequency are subject specific; subjects will receive treatment for up to 12 months

Locations

Country	Name	City	State
Austria	(Multiple sites in Austria) => Coordinating CRO: H&P GmbH	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Indivior Inc.

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention Rate	The primary objective of this study was to determine the retention rate of patients after 6 and 12 months of treatment with buprenorphine/naloxone measured by the percentage of patients remaining in the study	month 6, month 12	No
Secondary	Dosing of Suboxone (Buprenorphine Plus Naloxone)	One of the secondary objectives was to evaluate the effect of the switch to buprenorphine/naloxone on medication dispensing measured by dose.	day 1, month 6, month 12	No
Secondary	Dispensing of Suboxone (Buprenorphine Plus Naloxone)	Another of the secondary objectives was to evaluate the effect of the switch to Suboxone (buprenorphine plus naloxone) on medication dispensing measured by frequency of visits to the treating physician or pharmacy to receive the medication (daily, biweekly, once weekly, monthly, other)	month 6, month 12	No