Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (Study P05444)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opiate-related Disorders; Opiate Dependence; Drug Abuse
Intervention: buprenorphine/naloxone (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Schering-Plough Overall contact:
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
Summary
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.
Clinical Details
Official title: Evaluation of Transfer From Subutex or Other Treatment for Opioid Drug Dependence to Suboxone: Acceptability, Safety and Impact on Medication Dispensing
Study design: Cohort, Prospective
Primary outcome: Retention Rate
Secondary outcome: Frequency of Adverse EventsMedication dispensing as measured by dose and dispensing information in the patient's chart
Detailed description:
Nonprobability sampling was done by invitation to volunteer.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
Coordinating Location, Traiskirchen, Austria; Recruiting
Additional Information
Starting date: April 2008
Ending date: December 2010
Last updated: October 5, 2009
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