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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)


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.


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


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

Page last updated: August 23, 2015

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