N/A
N=1,307
Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED)
Buprenorphine · Naloxone · Opiate-related Disorders · Opiate Dependence · Drug Abuse
Bottom Line
View on ClinicalTrials.gov: NCT00723697 ↗Enrolled (actual)
1,307
Serious AEs
2.6%
Results posted
May 2011
Primary outcome: Primary: Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) — 131; 20; 15; 38 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- buprenorphine (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Indivior Inc.
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) |
131; 20; 15; 38; 19; 24 | — |
| PRIMARY Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician. |
206; 37; 37; 134; 52; 49 | — |
| SECONDARY Number of Patients Reporting Clinical Consequences of Engaging in Misuse |
41; 29; 31; 99; 65; 63 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00723697). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.