Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (NIS P05444)
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):
Gabriele Fischer, Prof. Dr., Principal Investigator, Affiliation: Medical University Vienna
Summary
The purpose of this study is to evaluate the acceptability and safety of switching to
Suboxone® (buprenorphine plus naloxone) and the effect of the switch on medication
dispensing. Subjects, for whom a therapy with Suboxone® is indicated and planned prior to
study enrollment and who are willing to participate, will initiate therapy on Day 1 of the
study. The dosage will be adjusted between Day 2 to 7 depending on patient's needs and
determined by the treating physicians in accordance with the SmPC of Suboxone®. Data will
be collected at baseline, day 1 til 7, the end of weeks 2 and 4 and 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: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Retention Rate
Secondary outcome: Dosing of Suboxone (Buprenorphine Plus Naloxone)Dispensing of Suboxone (Buprenorphine Plus Naloxone)
Detailed description:
Nonprobability sampling was done by invitation to volunteer.
Eligibility
Minimum age: 15 Years.
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.
- Therapeutic indications and contraindications for Suboxone® must be taken into
consideration when selecting patients.
Exclusion Criteria:
- According to product information
- In accordance with the product information pregnant women will be excluded.
Locations and Contacts
(Multiple sites in Austria) => Coordinating CRO: H&P GmbH, Vienna 1070, Austria
Additional Information
Starting date: May 2008
Last updated: April 26, 2012
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