Treatment of Opioid Dependent Patients With Suboxone: Acceptability & Safety Data From Real Life Scenario (Study P05603)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Opioid-Related Disorders Opiate Dependence Drug Abuse |
Drug: Buprenorphine/Naloxone |
| Study Type: | Observational |
| 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)
| Enrollment: | 384 |
| Study Start Date: | March 2008 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Suboxone
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.
|
Drug: Buprenorphine/Naloxone
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:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Opioid-dependent 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.
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Reckitt Benckiser Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT00723749 History of Changes |
| Other Study ID Numbers: | P05603 |
| Study First Received: | July 25, 2008 |
| Results First Received: | January 11, 2012 |
| Last Updated: | April 26, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices Germany: National Association of Statutory Health Insurance Physicians Germany: Federal Association of Company Health Insurance Fund |
Keywords provided by Reckitt Benckiser Pharmaceuticals Inc.:
|
Suboxone Subutex Buprenorphine Naloxone |
Additional relevant MeSH terms:
|
Substance-Related Disorders Opioid-Related Disorders Mental Disorders Buprenorphine Analgesics, Opioid Naloxone Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotic Antagonists Narcotics |
ClinicalTrials.gov processed this record on May 16, 2013