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

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.

Study NCT00723697 Information provided by Reckitt Benckiser Pharmaceuticals, Inc

First Received on July 25, 2008. Last Updated on April 14, 2011 History of Changes

Results First Received: April 14, 2011

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Conditions:	Buprenorphine Naloxone Opiate-related Disorders Opiate Dependence Drug Abuse
Intervention:	Drug: buprenorphine

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Patients	Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.

Participant Flow: Overall Study

	Patients
STARTED	1307
COMPLETED	1289
NOT COMPLETED	18
Physician questionnaires not received	2
Missing Informed Consent Form	10
Other exclusion criteria applied	6

Baseline Characteristics

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Reporting Groups

	Description
Patients	Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.

Baseline Measures

	Patients
Number of Participants [units: participants]	879
Age ^[1] [units: years] Mean ( Full Range )	34.70 ( 14 to 70 )
Gender ^[2] [units: participants]
Female	192
Male	687

[1]	A total of 880 patients returned a Day 1 self-questionnaire; only 824 patients had identifiable ages.
[2]	A total of 880 patients returned a Day 1 self-questionnaire; 879 patients had identified gender.

Outcome Measures

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1. Primary:

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 ]

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2. Primary:

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 ]

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3. Secondary:

Number of Patients Reporting Clinical Consequences of Engaging in Misuse [ Time Frame: first visit, 6 months, and 12 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No publication (abstract, poster, communication...) can be made without the agreement of SCHERING-PLOUGH.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com

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 - French Health Products Safety Agency