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:
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
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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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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 ]

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 ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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:
unchecked 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.
unchecked 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.


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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)