Drug Abuse, Opiate Dependence, Opioid-Related Disorders
Conditions
Keywords
Suboxone, Subutex, Buprenorphine, Naloxone
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.
Interventions
DRUGbuprenorphine/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
Sponsors
Indivior Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Dosing of Suboxone (Buprenorphine Plus Naloxone) | 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) | 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) |
Countries
Austria
Participant flow
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
Participants by arm
| Arm | Count |
|---|---|
| Opioid Dependent Patients Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone) | 307 |
| Total | 307 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 14 |
| Overall Study | Individual reasons | 86 |
| Overall Study | Lost to Follow-up | 60 |
| Overall Study | Other | 7 |
Baseline characteristics
| Characteristic | Opioid Dependent Patients |
|---|---|
| Age, Continuous | 30.3 Years STANDARD_DEVIATION 7.3 |
| Region of Enrollment Austria | 307 participants |
| Sex: Female, Male Female | 73 Participants |
| Sex: Female, Male Male | 234 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 49 / 339 |
| serious Total, serious adverse events | 2 / 339 |
Outcome results
Primary
Retention Rate
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
Population: All eligible datasets were included in analysis population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Opioid Dependent Patients | Retention Rate | Retention rate after 6 months of treatment | 57.3 percentage of patients |
| Opioid Dependent Patients | Retention Rate | Retention rate after 12 months of treatment | 45.6 percentage of patients |
Secondary
Dispensing of Suboxone (Buprenorphine Plus Naloxone)
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
Population: All participants with eligible datasets were included in the final analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Opioid Dependent Patients | Dispensing of Suboxone (Buprenorphine Plus Naloxone) | N patients with dispensing data at month 6 | 183 Participants |
| Opioid Dependent Patients | Dispensing of Suboxone (Buprenorphine Plus Naloxone) | 6 month: Daily | 96 Participants |
| Opioid Dependent Patients | Dispensing of Suboxone (Buprenorphine Plus Naloxone) | Month 6: Biweekly | 1 Participants |
| Opioid Dependent Patients | Dispensing of Suboxone (Buprenorphine Plus Naloxone) | Month 6: Once weekly | 79 Participants |
| Opioid Dependent Patients | Dispensing of Suboxone (Buprenorphine Plus Naloxone) | Month 6: Monthly | 2 Participants |
| Opioid Dependent Patients | Dispensing of Suboxone (Buprenorphine Plus Naloxone) | Month 6: Other | 5 Participants |
| Opioid Dependent Patients | Dispensing of Suboxone (Buprenorphine Plus Naloxone) | N patients with dispensing data at month 12 | 142 Participants |
| Opioid Dependent Patients | Dispensing of Suboxone (Buprenorphine Plus Naloxone) | Month 12: Daily | 68 Participants |
| Opioid Dependent Patients | Dispensing of Suboxone (Buprenorphine Plus Naloxone) | Month 12: Once weekly | 63 Participants |
| Opioid Dependent Patients | Dispensing of Suboxone (Buprenorphine Plus Naloxone) | Month 12: Monthly | 1 Participants |
| Opioid Dependent Patients | Dispensing of Suboxone (Buprenorphine Plus Naloxone) | Month 12: Other | 9 Participants |
| Opioid Dependent Patients | Dispensing of Suboxone (Buprenorphine Plus Naloxone) | Month 12: Biweekly | 1 Participants |
Secondary
Dosing of Suboxone (Buprenorphine Plus Naloxone)
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
Population: All participants with eligible datasets were included in the final analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Opioid Dependent Patients | Dosing of Suboxone (Buprenorphine Plus Naloxone) | Suboxone® dose day 1 (mg) | 7.7 Dose of Suboxone® in mg | Standard Deviation 4.9 |
| Opioid Dependent Patients | Dosing of Suboxone (Buprenorphine Plus Naloxone) | Suboxone® dose month 6 (mg) | 9.1 Dose of Suboxone® in mg | Standard Deviation 5.1 |
| Opioid Dependent Patients | Dosing of Suboxone (Buprenorphine Plus Naloxone) | Suboxone® dose month 12 (mg) | 8.5 Dose of Suboxone® in mg | Standard Deviation 4.8 |