Treatment of Opioid Dependent Patients With Suboxone: Acceptability & Safety Data From Real Life Scenario (Study P05603)

Opioid-Related Disorders Clinical Trial

Official title:

Post-marketing Surveillance Study (Paper-AWB) for GPs and Clinics: Treatment of Opioid-dependent Patients With SUBOXONE® 2 mg / 8 mg Sublingual Tablets - Acceptability and Safety Data From a Real Life Scenario.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723749
• Other study ID #: P05603
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: April 26, 2012
• Start date: March 2008
• Est. completion date: December 2010

Study information

• Verified date: April 2012
• Source: Indivior Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesGermany: National Association of Statutory Health Insurance PhysiciansGermany: Federal Association of Company Health Insurance Fund
• Study type: Observational

Clinical Trial Summary

The aim of this post marketing surveillance study is to investigate the retention rate after 12 months of drug dependence treatment with SUBOXONE® (buprenorphine plus naloxone) of opioid dependent patients under real life conditions.

Description:

Nonprobability sampling was done by invitation to volunteer with the intention to document 4 to 5 patients per physician where a substitution therapy with Suboxone is planned and indicated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 384
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Both adult and adolescent patients over 15 years of age who have consented to addiction treatment for opioid dependence within the scope of medical, social and psychotherapeutic measures can be included. Therapeutic indications and contraindications for SUBOXONE® must be observed when selecting patients.

Exclusion Criteria:

• In accordance with the product information, it is to be taken into consideration that patients are not suffering simultaneously from acute alcoholism, delirium tremens, or severe respiratory and severe liver insufficiency.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Drug Abuse
• Opiate Dependence
• Opioid-Related Disorders

Intervention

Drug:
• Buprenorphine/Naloxone
Sublingual combination tablet containing buprenorphine and naloxone at a ration of 4:1, respectively. It is available in two tablet strengths: 2 mg buprenorphine & 0.5 mg naloxone and 8 mg buprenorphine & 2 mg naloxone. The only effective and safe use is sublingual administration. SUBOXONE® use will occur on the basis of SPC and is solely aimed at medical-therapeutic necessity.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Indivior Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention Rate After 12 Months of Treatment With Suboxone	The primary aim of the SUBOXONE® NIS was to document the 12-month retention rate for at least N = 300 subjects with opioid dependence in a real-life scenario in at least N = 70 sites throughout Germany.	12 months	No
Secondary	Dosage of SUBOXONE®	Circumstances of switching to SUBOXONE®: Analyse induction and maintenance dose of SUBOXONE®.	Day 1 and Final Assessment (month 12 or time of dropout)	Yes
Secondary	Take Home Prescriptions of SUBOXONE®	Circumstances of switching to SUBOXONE®: Analyze if the number of take home prescriptions of SUBOXONE®, reported by the treating physician, increase between day 1 and the final assessment.; Take Home prescription is defined as a prescription of up to 7 daily dosages SUBOXONE® from the treating physician which allows the patients to receive the prescribed amount of daily dosages SUBOXONE® from a pharmacy to take home and dispense the medication on his own on a daily basis.; A patient can receive only one take home prescription for up to 7 days at the time.	Day 1 and Final Assessment (month 12 or time of dropout)	Yes
Secondary	Drug Craving (Subjective Effects of Therapy)	Circumstances of switching to SUBOXONE®: Analyse change of drug craving for opiates by using a 100mm visual analog scale (minimum: 0 = no craving; maximum: 100 = high craving)	Baseline and Final Assessment (month 12 or time of dropout)	Yes