Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED) (OPUS R)
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| ClinicalTrials.gov Identifier: NCT00723697 |
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Recruitment Status :
Completed
First Posted : July 29, 2008
Results First Posted : May 10, 2011
Last Update Posted : May 10, 2011
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Sponsor:
Indivior Inc.
Information provided by:
Indivior Inc.
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Brief Summary:
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 or disease | Intervention/treatment |
|---|---|
| Buprenorphine Naloxone Opiate-related Disorders Opiate Dependence Drug Abuse | Drug: buprenorphine |
| Study Type : | Observational |
| Actual Enrollment : | 1307 participants |
| 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 |
| Study Start Date : | May 2007 |
| Actual Primary Completion Date : | February 2010 |
| Actual Study Completion Date : | February 2010 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Opioid addiction
| Group/Cohort | Intervention/treatment |
|---|---|
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Patients
Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
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Drug: buprenorphine
0.4, 2, or 8 mg sublingual tablets
Other Names:
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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 ]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 ]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 ]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.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| 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
No Contacts or Locations Provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00723697 |
| Other Study ID Numbers: |
P05186 |
| First Posted: | July 29, 2008 Key Record Dates |
| Results First Posted: | May 10, 2011 |
| Last Update Posted: | May 10, 2011 |
| Last Verified: | July 2010 |
Keywords provided by Indivior Inc.:
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Subutex |
Additional relevant MeSH terms:
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Substance-Related Disorders Opioid-Related Disorders Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Buprenorphine Analgesics, Opioid |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists |