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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.

Tracking Information
First Submitted Date July 25, 2008
First Posted Date July 30, 2008
Results First Submitted Date October 18, 2011
Results First Posted Date March 23, 2012
Last Update Posted Date March 3, 2017
Study Start Date May 2008
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 12, 2012)
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
Original Primary Outcome Measures
 (submitted: July 25, 2008)
Retention Rate [ Time Frame: 6 months, 12 months ]
Change History Complete list of historical versions of study NCT00725608 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 12, 2012)
  • 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.
  • 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)
Original Secondary Outcome Measures
 (submitted: July 25, 2008)
  • Frequency of Adverse Events [ Time Frame: 6 months, 12 months ]
  • Medication dispensing as measured by dose and dispensing information in the patient's chart [ Time Frame: 6 months, 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (NIS P05444)
Official Title Evaluation of Transfer From Subutex or Other Treatment for Opioid Drug Dependence to Suboxone: Acceptability, Safety and Impact on Medication Dispensing
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.
Detailed Description Nonprobability sampling was done by invitation to volunteer.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients on substitution therapy for opioid dependence willing to switch to Suboxone
Condition
  • Opioid-Related Disorders
  • Opiate Dependence
  • Drug Abuse
Intervention 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
Study Groups/Cohorts Patients
Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
Intervention: Drug: buprenorphine/naloxone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 12, 2012)
339
Original Estimated Enrollment
 (submitted: July 25, 2008)
300
Actual Study Completion Date April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria
Removed Location Countries  
 
Administrative Information
NCT Number NCT00725608
Other Study ID Numbers P05444
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Indivior Inc.
Study Sponsor Indivior Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Gabriele Fischer, Prof. Dr. Medical University Vienna
PRS Account Indivior Inc.
Verification Date January 2017