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Trial record 65 of 186 for:    BUPRENORPHINE AND NALOXONE

Treatment of Opioid Dependent Patients With Suboxone: Acceptability & Safety Data From Real Life Scenario (Study P05603)

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ClinicalTrials.gov Identifier: NCT00723749
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : April 5, 2012
Last Update Posted : April 30, 2012
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 384
Recruitment Details Recruitment of sites: Jan - Dec 2008 (General Practitioners, Out-Patient-Clinics, Clinics) Recruitment of patients: Mar 2008 - Dec 2009
Pre-assignment Details 384 patients were enrolled, 39 datasets were excluded from analysis because 1) physicians withdraw participation agreement, 2) drop-out of patient or final documentation not available
Arm/Group Title Suboxone
Hide Arm/Group Description Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
Period Title: Overall Study
Started 345 [1]
Completed 182
Not Completed 163
[1]
384 patients were enrolled, 36 non-eligible datasets were excluded from analysis
Arm/Group Title Suboxone
Hide Arm/Group Description Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
Overall Number of Baseline Participants 345
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 345 participants
35.2  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 345 participants
Female
81
  23.5%
Male
264
  76.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 345 participants
345
1.Primary Outcome
Title Retention Rate After 12 Months of Treatment With Suboxone
Hide Description The primary aim of the SUBOXONE® NIS was to document the 12-month retention rate for at least N = 300 subjects with opioid dependence in a real-life scenario in at least N = 70 sites throughout Germany.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation).
Arm/Group Title Suboxone
Hide Arm/Group Description:
Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
Overall Number of Participants Analyzed 345
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: % of participants
59.9
(54.9 to 65.1)
2.Secondary Outcome
Title Dosage of SUBOXONE®
Hide Description Circumstances of switching to SUBOXONE®: Analyse induction and maintenance dose of SUBOXONE®.
Time Frame Day 1 and Final Assessment (month 12 or time of dropout)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation).
Arm/Group Title Suboxone
Hide Arm/Group Description:
Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
Overall Number of Participants Analyzed 345
Mean (Standard Deviation)
Unit of Measure: mg daily dosage of Suboxone
Dosage: Day 1 9.2  (5.1)
Dosage: Final Assessment 7.7  (4.4)
3.Secondary Outcome
Title Take Home Prescriptions of SUBOXONE®
Hide Description

Circumstances of switching to SUBOXONE®: Analyze if the number of take home prescriptions of SUBOXONE®, reported by the treating physician, increase between day 1 and the final assessment.

Take Home prescription is defined as a prescription of up to 7 daily dosages SUBOXONE® from the treating physician which allows the patients to receive the prescribed amount of daily dosages SUBOXONE® from a pharmacy to take home and dispense the medication on his own on a daily basis.

A patient can receive only one take home prescription for up to 7 days at the time.

Time Frame Day 1 and Final Assessment (month 12 or time of dropout)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation).
Arm/Group Title Suboxone
Hide Arm/Group Description:
Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
Overall Number of Participants Analyzed 345
Measure Type: Number
Unit of Measure: participants with take home prescription
Frequency: Day 1 28
Frequency: Final Assessment 82
4.Secondary Outcome
Title Drug Craving (Subjective Effects of Therapy)
Hide Description Circumstances of switching to SUBOXONE®: Analyse change of drug craving for opiates by using a 100mm visual analog scale (minimum: 0 = no craving; maximum: 100 = high craving)
Time Frame Baseline and Final Assessment (month 12 or time of dropout)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation).
Arm/Group Title Suboxone
Hide Arm/Group Description:
Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
Overall Number of Participants Analyzed 345
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Craving: Baseline 32.3  (33.1)
Craving: Final Assessment 7.1  (17.2)
Time Frame from enrollement (day 0) until 30 days after end of observation = 13 months per patient maximum
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Suboxone
Hide Arm/Group Description Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
All-Cause Mortality
Suboxone
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Suboxone
Affected / at Risk (%) # Events
Total   10/384 (2.60%)    
Injury, poisoning and procedural complications   
accident at home * 1  1/384 (0.26%)  1
Nervous system disorders   
epilepsy * 1  1/384 (0.26%)  1
Psychiatric disorders   
alcohol withdrawal syndrome * 1 [1]  1/384 (0.26%)  1
adjustment disorder * 1 [2]  1/384 (0.26%)  1
alcohol misuse * 1  1/384 (0.26%)  1
acute psychosis * 1 [3]  1/384 (0.26%)  1
medication addiction * 1 [4]  1/384 (0.26%)  4
Social circumstances   
non-compliance * 1 [5]  1/384 (0.26%)  1
Surgical and medical procedures   
planned abortion * 1  1/94 (1.06%)  1
hospitalization * 1  1/384 (0.26%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
[1]
C2 withdrawal - termination of treatment
[2]
hospitilization in psychiatry
[3]
acute exacerbation of psychosis
[4]
serious withdrawal syndrome, craving, red eyes, no bowel movement, risk of relapse = termination of treatment
[5]
concomitant heroin use
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Suboxone
Affected / at Risk (%) # Events
Total   0/384 (0.00%)    
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.
Trial results belong to the Sponsor only, all investigators are not allowed to publish trial 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: NCT00723749     History of Changes
Other Study ID Numbers: P05603
First Submitted: July 25, 2008
First Posted: July 29, 2008
Results First Submitted: January 11, 2012
Results First Posted: April 5, 2012
Last Update Posted: April 30, 2012