Trial Outcomes & Findings for Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (NIS P05444) (NCT NCT00725608)
NCT ID: NCT00725608
Last Updated: 2017-03-03
Results Overview
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
COMPLETED
339 participants
month 6, month 12
2017-03-03
Participant Flow
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
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
Participant milestones
| Measure |
Opioid Dependent Patients
Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
|
|---|---|
|
Overall Study
STARTED
|
307
|
|
Overall Study
COMPLETED
|
140
|
|
Overall Study
NOT COMPLETED
|
167
|
Reasons for withdrawal
| Measure |
Opioid Dependent Patients
Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
|
|---|---|
|
Overall Study
Lost to Follow-up
|
60
|
|
Overall Study
Adverse Event
|
14
|
|
Overall Study
Individual reasons
|
86
|
|
Overall Study
Other
|
7
|
Baseline Characteristics
Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (NIS P05444)
Baseline characteristics by cohort
| Measure |
Opioid Dependent Patients
n=307 Participants
Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
|
|---|---|
|
Age, Continuous
|
30.3 Years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
234 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
307 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: month 6, month 12Population: All eligible datasets were included in analysis population.
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
Outcome measures
| Measure |
Opioid Dependent Patients
n=307 Participants
Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
|
|---|---|
|
Retention Rate
Retention rate after 6 months of treatment
|
57.3 percentage of patients
Interval 51.8 to 62.9
|
|
Retention Rate
Retention rate after 12 months of treatment
|
45.6 percentage of patients
Interval 40.0 to 51.2
|
SECONDARY outcome
Timeframe: day 1, month 6, month 12Population: All participants with eligible datasets were included in the final analysis
One of the secondary objectives was to evaluate the effect of the switch to buprenorphine/naloxone on medication dispensing measured by dose.
Outcome measures
| Measure |
Opioid Dependent Patients
n=307 Participants
Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
|
|---|---|
|
Dosing of Suboxone (Buprenorphine Plus Naloxone)
Suboxone® dose day 1 (mg)
|
7.7 Dose of Suboxone® in mg
Standard Deviation 4.9
|
|
Dosing of Suboxone (Buprenorphine Plus Naloxone)
Suboxone® dose month 6 (mg)
|
9.1 Dose of Suboxone® in mg
Standard Deviation 5.1
|
|
Dosing of Suboxone (Buprenorphine Plus Naloxone)
Suboxone® dose month 12 (mg)
|
8.5 Dose of Suboxone® in mg
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: month 6, month 12Population: All participants with eligible datasets were included in the final analysis
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)
Outcome measures
| Measure |
Opioid Dependent Patients
n=307 Participants
Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
|
|---|---|
|
Dispensing of Suboxone (Buprenorphine Plus Naloxone)
N patients with dispensing data at month 6
|
183 Participants
|
|
Dispensing of Suboxone (Buprenorphine Plus Naloxone)
6 month: Daily
|
96 Participants
|
|
Dispensing of Suboxone (Buprenorphine Plus Naloxone)
Month 6: Biweekly
|
1 Participants
|
|
Dispensing of Suboxone (Buprenorphine Plus Naloxone)
Month 6: Once weekly
|
79 Participants
|
|
Dispensing of Suboxone (Buprenorphine Plus Naloxone)
Month 6: Monthly
|
2 Participants
|
|
Dispensing of Suboxone (Buprenorphine Plus Naloxone)
Month 6: Other
|
5 Participants
|
|
Dispensing of Suboxone (Buprenorphine Plus Naloxone)
N patients with dispensing data at month 12
|
142 Participants
|
|
Dispensing of Suboxone (Buprenorphine Plus Naloxone)
Month 12: Daily
|
68 Participants
|
|
Dispensing of Suboxone (Buprenorphine Plus Naloxone)
Month 12: Biweekly
|
1 Participants
|
|
Dispensing of Suboxone (Buprenorphine Plus Naloxone)
Month 12: Once weekly
|
63 Participants
|
|
Dispensing of Suboxone (Buprenorphine Plus Naloxone)
Month 12: Monthly
|
1 Participants
|
|
Dispensing of Suboxone (Buprenorphine Plus Naloxone)
Month 12: Other
|
9 Participants
|
Adverse Events
Opioid Dependent Patients
Serious adverse events
| Measure |
Opioid Dependent Patients
n=339 participants at risk
Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
|
|---|---|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.29%
1/339 • Number of events 1 • 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
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
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.29%
1/339 • Number of events 1 • 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
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
|
Other adverse events
| Measure |
Opioid Dependent Patients
n=339 participants at risk
Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
|
|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
7.4%
25/339 • Number of events 43 • 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
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
|
|
General disorders
General disorders and administration site conditions
|
7.1%
24/339 • Number of events 36 • 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
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
|
|
Psychiatric disorders
Psychiatric disorders
|
5.0%
17/339 • Number of events 26 • 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
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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Study results belong to the Sponsor only, all investigators are not allowed to publish study results without permission of the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER