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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine/Naloxone | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Dosage of SUBOXONE® | Circumstances of switching to SUBOXONE®: Analyse induction and maintenance dose of SUBOXONE®. | Day 1 and Final Assessment (month 12 or time of dropout) |
| Take Home Prescriptions of SUBOXONE® |
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Inclusion Criteria:
Exclusion Criteria:
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Opioid-dependent 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.
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| Name | Affiliation | Role |
|---|---|---|
| Markus Backmund, PD Dr. med. | Praxiszentrum im Tal (pit), Munich (Germany) | Principal Investigator |
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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
Recruitment of sites: Jan - Dec 2008 (General Practitioners, Out-Patient-Clinics, Clinics) Recruitment of patients: Mar 2008 - Dec 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Dosage of SUBOXONE® | Circumstances of switching to SUBOXONE®: Analyse induction and maintenance dose of SUBOXONE®. | 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). | Posted | Mean | Standard Deviation | mg daily dosage of Suboxone | Day 1 and Final Assessment (month 12 or time of dropout) |
|
from enrollement (day 0) until 30 days after end of observation = 13 months per patient maximum
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| alcohol withdrawal syndrome | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment | C2 withdrawal - termination of treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Director | RB Pharmaceuticals | +1 (804) 379 1090 | Tim.Baxter@reckittbenckiser.com |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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|
|
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.
| Day 1 and Final Assessment (month 12 or time of dropout) |
| 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) | Baseline and Final Assessment (month 12 or time of dropout) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | 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). | Posted | Number | 95% Confidence Interval | % of participants | 12 months |
|
|
|
| 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. | 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). | Posted | Number | participants with take home prescription | Day 1 and Final Assessment (month 12 or time of dropout) |
|
|
|
| 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) | 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). | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Final Assessment (month 12 or time of dropout) |
|
|
|
| 10 |
| 384 |
| 0 |
| 384 |
|
| non-compliance | Social circumstances | MedDRA (11.1) | Non-systematic Assessment | concomitant heroin use |
|
| planned abortion | Surgical and medical procedures | MedDRA (11.1) | Non-systematic Assessment |
|
| adjustment disorder | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment | hospitilization in psychiatry |
|
| alcohol misuse | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| acute psychosis | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment | acute exacerbation of psychosis |
|
| medication addiction | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment | serious withdrawal syndrome, craving, red eyes, no bowel movement, risk of relapse = termination of treatment |
|
| hospitalization | Surgical and medical procedures | MedDRA (11.1) | Non-systematic Assessment |
|
| epilepsy | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| accident at home | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
|
Trial results belong to the Sponsor only, all investigators are not allowed to publish trial results without permission of the Sponsor.
| D006571 |
| Heterocyclic Compounds |
| D009270 | Naloxone |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |