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Completed

NCT Number: NCT00723749

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

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.

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Key information

Conditions

Opioid-related Disorders Chemically-Induced Disorders Drug Abuse Mental Disorders Narcotic-Related Disorders Opiate Dependence Substance-Related Disorders

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

buprenorphine/naloxone

Drug

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.

Other names: SCH 000484, SUBOXONE®

Primary outcomes

  1. Retention Rate After 12 Months of Treatment With Suboxone

    Time frame: 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 outcomes

  1. Dosage of SUBOXONE®

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

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

  2. Take Home Prescriptions of SUBOXONE®

    Time frame: 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.

  3. Drug Craving (Subjective Effects of Therapy)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Indivior Inc.

Industry

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 29, 2008
Registry last updated
Apr 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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