Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (NIS P05444)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00725608
First received: July 25, 2008
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Opioid-Related Disorders
Opiate Dependence
Drug Abuse
Drug: buprenorphine/naloxone

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Transfer From Subutex or Other Treatment for Opioid Drug Dependence to Suboxone: Acceptability, Safety and Impact on Medication Dispensing

Resource links provided by NLM:


Further study details as provided by Reckitt Benckiser Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Retention Rate [ Time Frame: month 6, month 12 ] [ Designated as safety issue: No ]
    The primary objective of this study was to determine the retention rate of patients after 6 and 12 months of treatment with buprenorphine/naloxone measured by the percentage of patients remaining in the study


Secondary Outcome Measures:
  • Dosing of Suboxone (Buprenorphine Plus Naloxone) [ Time Frame: day 1, month 6, month 12 ] [ Designated as safety issue: No ]
    One of the secondary objectives was to evaluate the effect of the switch to buprenorphine/naloxone on medication dispensing measured by dose.

  • Dispensing of Suboxone (Buprenorphine Plus Naloxone) [ Time Frame: month 6, month 12 ] [ Designated as safety issue: No ]
    Another of the secondary objectives was to evaluate the effect of the switch to Suboxone (buprenorphine plus naloxone) on medication dispensing measured by frequency of visits to the treating physician or pharmacy to receive the medication (daily, biweekly, once weekly, monthly, other)


Enrollment: 339
Study Start Date: May 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients
Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
Drug: buprenorphine/naloxone
2/0.5 mg buprenorphine/naloxone and 8/2 mg buprenorphine/naloxone sublingual tablets; dosage and frequency are subject specific; subjects will receive treatment for up to 12 months
Other Name: Suboxone, SCH 000484

Detailed Description:

Nonprobability sampling was done by invitation to volunteer.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients on substitution therapy for opioid dependence willing to switch to Suboxone

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00725608

Locations
Austria
(Multiple sites in Austria) => Coordinating CRO: H&P GmbH
Vienna, Austria, 1070
Sponsors and Collaborators
Reckitt Benckiser Pharmaceuticals Inc.
Investigators
Principal Investigator: Gabriele Fischer, Prof. Dr. Medical University Vienna
  More Information

No publications provided

Responsible Party: Reckitt Benckiser Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00725608     History of Changes
Other Study ID Numbers: P05444
Study First Received: July 25, 2008
Results First Received: October 18, 2011
Last Updated: April 26, 2012
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Reckitt Benckiser Pharmaceuticals Inc.:
Suboxone
Subutex
Buprenorphine
Naloxone

Additional relevant MeSH terms:
Opioid-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Buprenorphine
Naloxone
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014