Treatment of Opioid Dependent Patients With Suboxone: Acceptability & Safety Data From Real Life Scenario (Study P05603)
Information source: Reckitt Benckiser Pharmaceuticals Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opioid-Related Disorders; Opiate Dependence; Drug Abuse
Intervention: Buprenorphine/Naloxone (Drug)
Phase: N/A
Status: Completed
Sponsored by: Reckitt Benckiser Pharmaceuticals Inc. Official(s) and/or principal investigator(s):
Markus Backmund, PD Dr. med., Principal Investigator, Affiliation: Praxiszentrum im Tal (pit), Munich (Germany)
Summary
The aim of this post marketing surveillance study is to investigate the retention rate after
12 months of drug dependence treatment with SUBOXONE® (buprenorphine plus naloxone) of
opioid dependent patients under real life 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 Data From a Real Life Scenario.
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Retention Rate After 12 Months of Treatment With Suboxone
Secondary outcome: Dosage of SUBOXONE®Take Home Prescriptions of SUBOXONE® Drug Craving (Subjective Effects of Therapy)
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 and
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
Additional Information
Starting date: March 2008
Last updated: April 26, 2012
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