Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (Study P05444) - Full Text View

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00725608

Purpose

The purpose of this study is to evaluate the acceptibility and safety of switching to buprenorphine/naloxone (Suboxone®) and the effect of the switch on medication dispensing. Subjects will initiate therapy on Day 1 of the study; dosage will be adjusted between Day 2 to 7. Data will be collected at the end of Weeks 2 and 4, then monthly up to the end of Month 12.

Condition	Intervention
Opiate-related Disorders Opiate Dependence Drug Abuse	Drug: buprenorphine/naloxone

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Evaluation of Transfer From Subutex or Other Treatment for Opioid Drug Dependence to Suboxone: Acceptability, Safety and Impact on Medication Dispensing

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: 6 months, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Frequency of Adverse Events [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: Yes ]
Medication dispensing as measured by dose and dispensing information in the patient's chart [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

Groups/Cohorts	Assigned Interventions
Patients Patients receiving substitution treatment for opioid drug dependence	Drug: buprenorphine/naloxone 2/0.5 mg buprenorphine/naloxone and 8/2 mg buprenorphine/naloxone sublingual tablets; dosage and frequency are subject specific; subjects will receive treatment for upto 12 months

Detailed Description:

Nonprobability sampling was done by invitation to volunteer.

Eligibility

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

Study Population

All patients on substitution therapy for opioid dependence willing to switch to Suboxone

Criteria

Inclusion Criteria:

All patients on substitution therapy, that are willing to switch to Suboxone, can be included.

Exclusion Criteria:

Pregnant women - see SmPC - will be excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00725608

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Locations

Austria
Coordinating Location	Recruiting
Traiskirchen, Austria

Sponsors and Collaborators

Schering-Plough

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P05444
Study First Received:	July 25, 2008
Last Updated:	November 4, 2009
ClinicalTrials.gov Identifier:	NCT00725608 History of Changes
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by Schering-Plough:

Suboxone
Subutex
Buprenorphine
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 November 20, 2009