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:	Observational Model: Cohort Time Perspective: 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 ]

Estimated Enrollment:	300
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 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 Other Name: suboxone, SCH 000484

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:	Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00725608 History of Changes
Other Study ID Numbers:	P05444
Study First Received:	July 25, 2008
Last Updated:	January 25, 2011
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by Schering-Plough:

Suboxone
Subutex
Buprenorphine
Naloxone

Additional relevant MeSH terms:

Substance-Related Disorders
Opioid-Related Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Naloxone
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