Treatment of Opioid Dependent Patients With Suboxone: Acceptability & Safety Data From Real Life Scenario (Study P05603)
|ClinicalTrials.gov Identifier: NCT00723749|
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : April 5, 2012
Last Update Posted : April 30, 2012
|Condition or disease||Intervention/treatment|
|Opioid-Related Disorders Opiate Dependence Drug Abuse||Drug: Buprenorphine/Naloxone|
|Study Type :||Observational|
|Actual Enrollment :||384 participants|
|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.|
|Study Start Date :||March 2008|
|Primary Completion Date :||December 2010|
|Study Completion Date :||December 2010|
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.
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.
- 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.
- 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®.
- 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.
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00723749
|Principal Investigator:||Markus Backmund, PD Dr. med.||Praxiszentrum im Tal (pit), Munich (Germany)|