Drug Abuse, Opiate Dependence, Opioid-Related Disorders
Conditions
Keywords
Suboxone, Subutex, Buprenorphine, Naloxone
Brief summary
The aim of this post marketing surveillance study is to investigate the retention rate after 12 months of drug dependence treatment with SUBOXONE® (buprenorphine plus naloxone) of opioid dependent patients under real life conditions.
Detailed description
Nonprobability sampling was done by invitation to volunteer with the intention to document 4 to 5 patients per physician where a substitution therapy with Suboxone is planned and indicated.
Interventions
DRUGBuprenorphine/Naloxone
Sublingual combination tablet containing buprenorphine and naloxone at a ration of 4:1, respectively. It is available in two tablet strengths: 2 mg buprenorphine & 0.5 mg naloxone and 8 mg buprenorphine & 2 mg naloxone. The only effective and safe use is sublingual administration. SUBOXONE® use will occur on the basis of SPC and is solely aimed at medical-therapeutic necessity.
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
* Both adult and adolescent patients over 15 years of age who have consented to addiction treatment for opioid dependence within the scope of medical, social and psychotherapeutic measures can be included. Therapeutic indications and contraindications for SUBOXONE® must be observed when selecting patients.
Exclusion criteria
* In accordance with the product information, it is to be taken into consideration that patients are not suffering simultaneously from acute alcoholism, delirium tremens, or severe respiratory and severe liver insufficiency.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention Rate After 12 Months of Treatment With Suboxone | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dosage of SUBOXONE® | Day 1 and Final Assessment (month 12 or time of dropout) | Circumstances of switching to SUBOXONE®: Analyse induction and maintenance dose of SUBOXONE®. |
| Take Home Prescriptions of SUBOXONE® | Day 1 and Final Assessment (month 12 or time of dropout) | 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. |
| Drug Craving (Subjective Effects of Therapy) | Baseline and Final Assessment (month 12 or time of dropout) | 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) |
Participant flow
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
Participants by arm
| Arm | Count |
|---|---|
| Suboxone 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. | 345 |
| Total | 345 |
Baseline characteristics
| Characteristic | Suboxone |
|---|---|
| Age Continuous | 35.2 years STANDARD_DEVIATION 8.9 |
| Region of Enrollment Germany | 345 participants |
| Sex: Female, Male Female | 81 Participants |
| Sex: Female, Male Male | 264 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 384 |
| serious Total, serious adverse events | 10 / 384 |
Outcome results
Primary
Retention Rate After 12 Months of Treatment With Suboxone
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Suboxone | Retention Rate After 12 Months of Treatment With Suboxone | 59.9 % of participants |
Secondary
Dosage of SUBOXONE®
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)
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Suboxone | Dosage of SUBOXONE® | Dosage: Final Assessment | 7.7 mg daily dosage of Suboxone | Standard Deviation 4.4 |
| Suboxone | Dosage of SUBOXONE® | Dosage: Day 1 | 9.2 mg daily dosage of Suboxone | Standard Deviation 5.1 |
Secondary
Drug Craving (Subjective Effects of Therapy)
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)
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Suboxone | Drug Craving (Subjective Effects of Therapy) | Craving: Baseline | 32.3 Units on a scale | Standard Deviation 33.1 |
| Suboxone | Drug Craving (Subjective Effects of Therapy) | Craving: Final Assessment | 7.1 Units on a scale | Standard Deviation 17.2 |
Secondary
Take Home Prescriptions of SUBOXONE®
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)
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Suboxone | Take Home Prescriptions of SUBOXONE® | Frequency: Day 1 | 28 participants with take home prescription |
| Suboxone | Take Home Prescriptions of SUBOXONE® | Frequency: Final Assessment | 82 participants with take home prescription |