Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED) (OPUS R)
This study has been completed.
Sponsor:
Reckitt Benckiser Pharmaceuticals Inc.
Information provided by:
Reckitt Benckiser Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00723697
First received: July 25, 2008
Last updated: April 14, 2011
Last verified: July 2010
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Purpose
The purpose of this study is to assess the risks of abuse, misuse and adverse events related to high dose buprenorphine. Approximately 1250 patients taking Subutex (Schering-Plough) or its Buprenorphine High Dose (BHD) generic (Arrow Laboratories) will participate in this study. Data will be collected using physician questionnaires and self evaluation patient questionnaires at the first visit and visits at 6 and 12 months.
| Condition | Intervention |
|---|---|
|
Buprenorphine Naloxone Opiate-related Disorders Opiate Dependence Drug Abuse |
Drug: buprenorphine |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Etude Observationnelle Prospective de l'Utilisation en Situation Reelle; Prospective Real Situation Observational Study of Subutex® or Its Buprenorphine High Dose Generic (BHD) in the Replacement Treatment of Major Opiate Dependence: Following Parameters With Respect to Misuse and Pharmacovigilance |
Resource links provided by NLM:
Further study details as provided by Reckitt Benckiser Pharmaceuticals Inc.:
Primary Outcome Measures:
- Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) [ Time Frame: first visit, 6 months, and 12 months ] [ Designated as safety issue: Yes ]Number of patients who indicate misuse behaviours on self-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.
- Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician. [ Time Frame: first visit, 6 months, and 12 months ] [ Designated as safety issue: Yes ]Number of patients with misuse behaviours on physician-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.
Secondary Outcome Measures:
- Number of Patients Reporting Clinical Consequences of Engaging in Misuse [ Time Frame: first visit, 6 months, and 12 months ] [ Designated as safety issue: No ]Number of patients with clinical consequences (development or progression of: abscess, nutritional deficiency, dental problems, psychiatric problems including depression, sleep problems, schizophrenia, anxiety, phobias, hallucinations, delirium, withdrawal symptoms, inhibition, suicide attempts and other problems) at first, 6 month, and/or 12 month visit.
| Enrollment: | 1307 |
| Study Start Date: | May 2007 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Patients
Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
|
Drug: buprenorphine
0.4, 2, or 8 mg sublingual tablets
Other Names:
|
Detailed Description:
Approximately 380 physicians will participate in this study. Patients will be enrolled in chronological order of consultations.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients addicted to opiates and requiring replacement treatment with Subutex (Schering-Plough) or BHD generic (Arrow laboratories)
Criteria
Inclusion Criteria:
- Eligible patients will be those already having a prescription for Subutex or its BHD generic, or being proposed a prescription for Subutex or its BHD generic for the first time when consulting the participating physician.
- The patient must have been informed orally and in writing via the information notice and have signed it.
Exclusion Criteria:
- Criteria of non-eligibility will be related to the contraindications in the Marketing Authorization (MA) of Subutex or its BHD generic
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00723697 History of Changes |
| Other Study ID Numbers: | P05186 |
| Study First Received: | July 25, 2008 |
| Results First Received: | April 14, 2011 |
| Last Updated: | April 14, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Reckitt Benckiser Pharmaceuticals Inc.:
|
Subutex |
Additional relevant MeSH terms:
|
Substance-Related Disorders Opioid-Related Disorders Mental Disorders Buprenorphine Analgesics, Opioid 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 23, 2013