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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

July 25, 2008
April 14, 2011
May 2007
February 2010   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Number of patients with misuse behaviours on physician-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.
Percentage of subjects reporting misuse (injection, sniffing, dose fractionation, modification of prescribed doses, and combination with psychotropic agents) [ Time Frame: first visit, 6 months, and 12 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00723697 on ClinicalTrials.gov Archive Site
Number of Patients Reporting Clinical Consequences of Engaging in Misuse [ Time Frame: first visit, 6 months, and 12 months ] [ Designated as safety issue: No ]
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.
To study the impact of misuse on the clinical status of the patients treated by HDB; To describe the adverse events related to HDB [ Time Frame: first visit, 6 months, and 12 months ] [ Designated as safety issue: Yes ]
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Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED)
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

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.

Approximately 380 physicians will participate in this study. Patients will be enrolled in chronological order of consultations.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

Patients addicted to opiates and requiring replacement treatment with Subutex (Schering-Plough) or BHD generic (Arrow laboratories)

  • Buprenorphine
  • Naloxone
  • Opiate-related Disorders
  • Opiate Dependence
  • Drug Abuse
Drug: buprenorphine
0.4, 2, or 8 mg sublingual tablets
Other Names:
  • Subutex
  • buprenorphine high dose (BHD) generic (Arrow Laboratories)
  • SCH 028444
Patients
Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
Intervention: Drug: buprenorphine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1307
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00723697
P05186
No
Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Reckitt Benckiser Pharmaceuticals Inc.
Not Provided
Not Provided
Reckitt Benckiser Pharmaceuticals Inc.
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP