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

Sponsor:	Reckitt Benckiser Pharmaceuticals, Inc
Information provided by:	Reckitt Benckiser Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:	NCT00723697

Purpose

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.

Condition	Intervention
Buprenorphine Naloxone Opiate-related Disorders Opiate Dependence Drug Abuse	Drug: buprenorphine

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Further study details as provided by Reckitt Benckiser Pharmaceuticals, Inc:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

Enrollment:	1307
Study Start Date:	May 2007
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Patients Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.	Drug: buprenorphine 0.4, 2, or 8 mg sublingual tablets Other Names: Subutex buprenorphine high dose (BHD) generic (Arrow Laboratories) SCH 028444

Detailed Description:

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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

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

Contacts and Locations

No Contacts or Locations Provided

More Information

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

Keywords provided by Reckitt Benckiser Pharmaceuticals, Inc:

Subutex

Additional relevant MeSH terms:

Substance-Related Disorders
Opioid-Related Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012