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

Indivior Inc.384 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

384

Conditions

Interventions

Buprenorphine/NaloxoneDRUG

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.

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

Dosage of SUBOXONE®

Circumstances of switching to SUBOXONE®: Analyse induction and maintenance dose of SUBOXONE®.

Time frame: Day 1 and Final Assessment (month 12 or time of dropout)

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.

Time frame: Day 1 and Final Assessment (month 12 or time of dropout)

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)

Time frame: Baseline and Final Assessment (month 12 or time of dropout)

Data from ClinicalTrials.gov

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