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

Completed

• Conditions: Opioid-Related Disorders; Opiate Dependence; Drug Abuse
• Interventions: Drug: Buprenorphine/Naloxone

• Registration Number: NCT00723749
• Lead Sponsor: Indivior Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-29
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2012-01-11
• Results First Submitted QC: 2012-02-28
• Status Verified: 2012-04
• Results First Posted: 2012-04-05
• Last Update Submitted: 2012-04-26
• Last Update Posted: 2012-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 384

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Suboxone	Buprenorphine/Naloxone	Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.

Primary Outcome Measures

Name	Time	Method
Retention Rate After 12 Months of Treatment With Suboxone	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Dosage of SUBOXONE®	Day 1 and Final Assessment (month 12 or time of dropout)	Circumstances of switching to SUBOXONE®: Analyse induction and maintenance dose of SUBOXONE®.
Take Home Prescriptions of SUBOXONE®	Day 1 and Final Assessment (month 12 or time of dropout)	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.
Drug Craving (Subjective Effects of Therapy)	Baseline and Final Assessment (month 12 or time of dropout)	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)