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

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
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:	Cohort, 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 Schering-Plough:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1250
Study Start Date:	May 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Patients Patients addicted to opiates and requiring replacement treatment	Drug: buprenorphine 0.4, 2, or 8 mg sublingual tablets

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:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P05186
Study First Received:	July 25, 2008
Last Updated:	September 3, 2009
ClinicalTrials.gov Identifier:	NCT00723697 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Schering-Plough:

Subutex

Study placed in the following topic categories:

Buprenorphine
Mental Disorders
Narcotic Antagonists
Substance-Related Disorders
Central Nervous System Depressants
Disorders of Environmental Origin

Narcotics
Peripheral Nervous System Agents
Analgesics
Opioid-Related Disorders
Analgesics, Opioid

Additional relevant MeSH terms:

Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Narcotics
Opioid-Related Disorders
Pharmacologic Actions
Buprenorphine

Mental Disorders
Sensory System Agents
Therapeutic Uses
Substance-Related Disorders
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on September 11, 2009