Treatment of Opioid Dependent Patients With Suboxone: Acceptability and Safety From Real Life Scenario (Study P05603)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opiate-Related Disorders; Opiate Dependence; Drug Abuse; Buprenorphine; Naloxone
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 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.
Clinical Details
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.
Study design: Cohort, Prospective
Primary outcome: Retention rate
Secondary outcome: Circumstances of switching to SUBOXONE® (dosage, frequency of intake, subjective effects
Acceptance and tolerance of SUBOXONE® treatment
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
Minimum age: 15 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
Coordinating Location, Munich, Germany; Recruiting
Additional Information
Starting date: January 2008
Ending date: December 2009
Last updated: October 20, 2008
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