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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00725608
Recruitment Status : Completed
First Posted : July 30, 2008
Results First Posted : March 23, 2012
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Indivior Inc.

Study Description
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Brief 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.

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

Detailed Description:
Nonprobability sampling was done by invitation to volunteer.
Study Design
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Study Type : Observational
Actual Enrollment : 339 participants
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
Study Start Date : May 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Retention Rate [ Time Frame: month 6, month 12 ]
    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 :
  1. Dosing of Suboxone (Buprenorphine Plus Naloxone) [ Time Frame: day 1, month 6, month 12 ]
    One of the secondary objectives was to evaluate the effect of the switch to buprenorphine/naloxone on medication dispensing measured by dose.

  2. Dispensing of Suboxone (Buprenorphine Plus Naloxone) [ Time Frame: month 6, month 12 ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00725608


Locations
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Austria
(Multiple sites in Austria) => Coordinating CRO: H&P GmbH
Vienna, Austria, 1070
Sponsors and Collaborators
Indivior Inc.
Investigators
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Principal Investigator: Gabriele Fischer, Prof. Dr. Medical University Vienna
More Information
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Responsible Party: Indivior Inc.
ClinicalTrials.gov Identifier: NCT00725608    
Other Study ID Numbers: P05444
First Posted: July 30, 2008    Key Record Dates
Results First Posted: March 23, 2012
Last Update Posted: March 3, 2017
Last Verified: January 2017
Keywords provided by Indivior Inc.:
Suboxone
Subutex
Buprenorphine
Naloxone
Additional relevant MeSH terms:
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Substance-Related Disorders
Opioid-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Narcotic-Related Disorders
Buprenorphine
Buprenorphine, Naloxone Drug Combination
Naloxone
 Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists