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

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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 Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Opioid-Related Disorders
Opiate Dependence
Drug Abuse
Intervention Drug: buprenorphine/naloxone
Enrollment 339
Recruitment Details

Recruitment period: May 2008 - December 2009 Patients were eligible for observation if the transfer from an ongoing opioid dependence therapy to Suboxone was indicated and planned prior to enrollment to P05444 by the treating physician.

Multiple sites in Austria: general practitioners, clinics/outpatient clinics, drug counseling centers, prisons

Pre-assignment Details 339 patients were enrolled, 32 datasets were excluded from analysis because of missing baseline assessment and/or missing final/dropout documentation = 307 eligible datasets were used for final general and safety analysis
Arm/Group Title Opioid Dependent Patients
Hide Arm/Group Description Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
Period Title: Overall Study
Started 307 [1]
Completed 140 [2]
Not Completed 167
Reason Not Completed
Lost to Follow-up             60
Adverse Event             14
Individual reasons             86
Other             7
[1]
339 patients enrolled, 32 non-eligible datasets excluded from final general and safety analysis
[2]
1 patient terminated treatment at day 368 and was counted as dropout
Arm/Group Title Opioid Dependent Patients
Hide Arm/Group Description Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
Overall Number of Baseline Participants 307
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 307 participants
30.3  (7.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 307 participants
Female
73
  23.8%
Male
234
  76.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Austria Number Analyzed 307 participants
307
1.Primary Outcome
Title Retention Rate
Hide Description 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
Time Frame month 6, month 12
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible datasets were included in analysis population.
Arm/Group Title Opioid Dependent Patients
Hide Arm/Group Description:
Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
Overall Number of Participants Analyzed 307
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
Retention rate after 6 months of treatment
57.3
(51.8 to 62.9)
Retention rate after 12 months of treatment
45.6
(40.0 to 51.2)
2.Secondary Outcome
Title Dosing of Suboxone (Buprenorphine Plus Naloxone)
Hide Description One of the secondary objectives was to evaluate the effect of the switch to buprenorphine/naloxone on medication dispensing measured by dose.
Time Frame day 1, month 6, month 12
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with eligible datasets were included in the final analysis
Arm/Group Title Opioid Dependent Patients
Hide Arm/Group Description:
Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
Overall Number of Participants Analyzed 307
Mean (Standard Deviation)
Unit of Measure: Dose of Suboxone® in mg
Suboxone® dose day 1 (mg) 7.7  (4.9)
Suboxone® dose month 6 (mg) 9.1  (5.1)
Suboxone® dose month 12 (mg) 8.5  (4.8)
3.Secondary Outcome
Title Dispensing of Suboxone (Buprenorphine Plus Naloxone)
Hide Description 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)
Time Frame month 6, month 12
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with eligible datasets were included in the final analysis
Arm/Group Title Opioid Dependent Patients
Hide Arm/Group Description:
Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
Overall Number of Participants Analyzed 307
Measure Type: Number
Unit of Measure: Participants
N patients with dispensing data at month 6 183
6 month: Daily 96
Month 6: Biweekly 1
Month 6: Once weekly 79
Month 6: Monthly 2
Month 6: Other 5
N patients with dispensing data at month 12 142
Month 12: Daily 68
Month 12: Biweekly 1
Month 12: Once weekly 63
Month 12: Monthly 1
Month 12: Other 9
Time Frame Adverse events were collected for total observational time of each patient: from start of treatment until end of observation or date of early discontinuation, respectively - maximum period 1 year
Adverse Event Reporting Description For description of safety data all patients enrolled and exposed to Suboxone® for at least one day(N=339) were included in the safety analysis
 
Arm/Group Title Opioid Dependent Patients
Hide Arm/Group Description Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
All-Cause Mortality
Opioid Dependent Patients
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Opioid Dependent Patients
Affected / at Risk (%) # Events
Total   2/339 (0.59%)    
Injury, poisoning and procedural complications   
Facial bones fracture * 1 [1]  1/339 (0.29%)  1
Pregnancy, puerperium and perinatal conditions   
Abortion missed * 1 [2]  1/339 (0.29%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
[1]
Hospitalization
[2]
no further information available
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Opioid Dependent Patients
Affected / at Risk (%) # Events
Total   49/339 (14.45%)    
Gastrointestinal disorders   
Gastrointestinal disorders * 1  25/339 (7.37%)  43
General disorders   
General disorders and administration site conditions * 1  24/339 (7.08%)  36
Psychiatric disorders   
Psychiatric disorders * 1  17/339 (5.01%)  26
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Study results belong to the Sponsor only, all investigators are not allowed to publish study results without permission of the Sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Director
Organization: RB Pharmaceuticals
Phone: +1 (804) 379 1090
EMail: Tim.Baxter@reckittbenckiser.com
Layout table for additonal information
Responsible Party: Indivior Inc.
ClinicalTrials.gov Identifier: NCT00725608     History of Changes
Other Study ID Numbers: P05444
First Submitted: July 25, 2008
First Posted: July 30, 2008
Results First Submitted: October 18, 2011
Results First Posted: March 23, 2012
Last Update Posted: March 3, 2017