CompletedNot Applicable

Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED)

1,307 participantsStarted 2007-05

Plain-language 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.

Who can participate

SexALL

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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

What they're measuring

Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents)

Timeframe: first visit, 6 months, and 12 months

Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician.

Timeframe: first visit, 6 months, and 12 months

Trial details

NCT IDNCT00723697

SponsorIndivior Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2010-02

Results submitted2011-04-14

View on ClinicalTrials.gov More Buprenorphine trials