Treatment of Opioid Dependent Patients With Suboxone: Acceptability & Safety Data From Real Life Scenario (Study P05603)
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|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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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)|