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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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.|
- Retention Rate After 12 Months of Treatment With Suboxone [ Time Frame: 12 months ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: Yes ]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) ] [ Designated as safety issue: Yes ]
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) ] [ Designated as safety issue: Yes ]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)
|Study Start Date:||March 2008|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00723749
|Principal Investigator:||Markus Backmund, PD Dr. med.||Praxiszentrum im Tal (pit), Munich (Germany)|