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The purpose of this study is to assess the risks of abuse, misuse and adverse events related to high dose buprenorphine. Approximately 1250 patients taking Subutex (Schering-Plough) or its Buprenorphine High Dose (BHD) generic (Arrow Laboratories) will participate in this study. Data will be collected using physician questionnaires and self evaluation patient questionnaires at the first visit and visits at 6 and 12 months.
Approximately 380 physicians will participate in this study. Patients will be enrolled in chronological order of consultations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| buprenorphine | Drug | 0.4, 2, or 8 mg sublingual tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) | Number of patients who indicate misuse behaviours on self-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits. | first visit, 6 months, and 12 months |
| Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician. | Number of patients with misuse behaviours on physician-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits. | first visit, 6 months, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Reporting Clinical Consequences of Engaging in Misuse | Number of patients with clinical consequences (development or progression of: abscess, nutritional deficiency, dental problems, psychiatric problems including depression, sleep problems, schizophrenia, anxiety, phobias, hallucinations, delirium, withdrawal symptoms, inhibition, suicide attempts and other problems) at first, 6 month, and/or 12 month visit. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients addicted to opiates and requiring replacement treatment with Subutex (Schering-Plough) or BHD generic (Arrow laboratories)
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients | Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| first visit, 6 months, and 12 months |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients | Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | A total of 880 patients returned a Day 1 self-questionnaire; only 824 patients had identifiable ages. | Mean | Full Range | years |
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| Sex: Female, Male | A total of 880 patients returned a Day 1 self-questionnaire; 879 patients had identified gender. | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) | Number of patients who indicate misuse behaviours on self-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits. | Number of patients with self-questionnaire responses. | Posted | Number | participants | first visit, 6 months, and 12 months |
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| Secondary | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | Number of patients with clinical consequences (development or progression of: abscess, nutritional deficiency, dental problems, psychiatric problems including depression, sleep problems, schizophrenia, anxiety, phobias, hallucinations, delirium, withdrawal symptoms, inhibition, suicide attempts and other problems) at first, 6 month, and/or 12 month visit. | Number of patients analyzed for the consequence, at each visit. | Posted | Number | participants | first visit, 6 months, and 12 months |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician. | Number of patients with misuse behaviours on physician-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits. | All eligible patients | Posted | Number | participants | first visit, 6 months, and 12 months |
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Two patients who did not have a first visit were excluded from the adverse event database.
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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 | Patients | 34 | 1,305 | 0 | 1,305 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CARDIAC DISORDER | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
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| HYPERTHYROIDISM | Endocrine disorders | MedDRA 11.0 | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| GASTROINTESTINAL STENOSIS | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 11.0 | Systematic Assessment |
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| INJECTION SITE NECROSIS | General disorders | MedDRA 11.0 | Systematic Assessment |
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| OEDEMA | General disorders | MedDRA 11.0 | Systematic Assessment |
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| LIVER DISORDER | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
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| INJECTION SITE ABSCESS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| PSOAS ABSCESS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| TUBERCULOSIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| SALIVARY GLAND CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
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| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| STATUS EPILEPTICUS | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| PREMATURE LABOUR | Pregnancy, puerperium and perinatal conditions | MedDRA 11.0 | Systematic Assessment |
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| DRUG DEPENDENCE | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| MENTAL DISORDER | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| WITHDRAWAL SYNDROME | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| RESPIRATORY DEPRESSION | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| ALCOHOL USE | Social circumstances | MedDRA 11.0 | Systematic Assessment |
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| DRUG DETOXIFICATION | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
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| AORTIC ANEURYSM RUPTURE | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
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| PHLEBITIS | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
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No publication (abstract, poster, communication...) can be made without the agreement of SCHERING-PLOUGH.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President of Late Stage Development | Merck Sharp & Dohme Corp | ClinicalTrialsDisclosure@merck.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 |
|---|---|
| D002047 | Buprenorphine |
| D016568 | Drugs, Generic |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| 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 |
| D004364 | Pharmaceutical Preparations |
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| Title | Measurements |
|---|---|
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| Misuse at D1 only |
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| Misuse at M6 and M12 only |
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| Misuse at D1 and M12 only |
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| Misuse at D1 and M6 only |
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| Misuse at all visits |
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| Missing Data |
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