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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


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.


Minimum age: 15 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- All patients on substitution therapy, that are willing to switch to Suboxone, can be


- 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

Page last updated: August 23, 2015

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