Treatment of Opioid Dependent Patients With Suboxone: Acceptability and Safety From Real Life Scenario (Study P05603) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00723749

Purpose

The aim of this post marketing surveillance study is to investigate the retention rate after 12 months of substitution treatment with SUBOXONE® (buprenorphine plus naloxone) of opioid dependent patients under everyday conditions.

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

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Post-marketing Surveillance Study (Paper-AWB) for GPs and Clinics: Treatment of Opioid-dependent Patients With SUBOXONE® 2 mg / 8 mg Sublingual Tablets - Acceptability and Safety Dates From a Real Life Scenario.

Resource links provided by NLM:

Drug Information available for: Buprenorphine Buprenorphine hydrochloride Naloxone hydrochloride Naloxone

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Retention rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Circumstances of switching to SUBOXONE® (dosage, frequency of intake, subjective effects Acceptance and tolerance of SUBOXONE® treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	300
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group 1 Patients where a substitution therapy with SUBOXONE® is planned or indicated, and who have already been pre-treated with SUBUTEX®, or another substitution medication for at least 6 months.	Drug: Buprenorphine/Naloxone Sublingual combination tablet containing buprenorphine and naloxone at a ration of 4:1, respectively. It is available in two tablet strengths: 2 mg buprenorphine / 0.5 mg naloxone and 8 mg buprenorphine / 2 mg naloxone. The only effective and safe use is sublingual administration. SUBOXONE® use will occur on the basis of SPC and is solely aimed at medical-therapeutic necessity.

Groups/Cohorts

Assigned Interventions

Group 1

Patients where a substitution therapy with SUBOXONE® is planned or indicated, and who have already been pre-treated with SUBUTEX®, or another substitution medication for at least 6 months.

Drug: Buprenorphine/Naloxone

Sublingual combination tablet containing buprenorphine and naloxone at a ration of 4:1, respectively. It is available in two tablet strengths: 2 mg buprenorphine / 0.5 mg naloxone and 8 mg buprenorphine / 2 mg naloxone. The only effective and safe use is sublingual administration. SUBOXONE® use will occur on the basis of SPC and is solely aimed at medical-therapeutic necessity.

Detailed Description:

Nonprobability sampling was done by invitation to volunteer with the intention to document 4 to 5 patients per physician where a substitution therapy with Suboxone is planned or indicated.

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Opioid-dependent patients where a substitution therapy with SUBOXONE® is planned or indicated, and who have already been pre-treated with SUBUTEX®, or another substitution medication for at least 6 months.

Criteria

Inclusion Criteria:

Both adult and adolescent patients over 15 years of age who have consented to addiction treatment for opioid dependence within the scope of medical, social and psychotherapeutic measures can be included.

Therapeutic indications and contraindications for SUBOXONE® must be observed when selecting patients.

Exclusion Criteria:

In accordance with the product information, it is to be taken into consideration that patients are not suffering simultaneously from acute alcoholism, delirium tremens, or severe respiratory and severe liver insufficiency.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723749

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Locations

Germany
Coordinating Location	Recruiting
Munich, Germany

Sponsors and Collaborators

Schering-Plough

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P05603
Study First Received:	July 25, 2008
Last Updated:	September 9, 2009
ClinicalTrials.gov Identifier:	NCT00723749 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Germany: National Association of Statutory Health Insurance Physicians; Germany: Federal Association of Company Health Insurance Fund

Keywords provided by Schering-Plough:

Suboxone
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
Naloxone

Additional relevant MeSH terms:

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