Buprenorphine, Drug Abuse, Naloxone, Opiate Dependence, Opiate-related Disorders
Conditions
Keywords
Subutex
Brief summary
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.
Detailed description
Approximately 380 physicians will participate in this study. Patients will be enrolled in chronological order of consultations.
Interventions
DRUGbuprenorphine
0.4, 2, or 8 mg sublingual tablets
Sponsors
Indivior Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Eligible patients will be those already having a prescription for Subutex or its BHD generic, or being proposed a prescription for Subutex or its BHD generic for the first time when consulting the participating physician. * The patient must have been informed orally and in writing via the information notice and have signed it.
Exclusion criteria
* Criteria of non-eligibility will be related to the contraindications in the Marketing Authorization (MA) of Subutex or its BHD generic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) | first visit, 6 months, and 12 months | 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 Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician. | first visit, 6 months, and 12 months | Number of patients with misuse behaviours on physician-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Reporting Clinical Consequences of Engaging in Misuse | first visit, 6 months, and 12 months | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice. | 879 |
| Total | 879 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Missing Informed Consent Form | 10 |
| Overall Study | Other exclusion criteria applied | 6 |
| Overall Study | Physician questionnaires not received | 2 |
Baseline characteristics
| Characteristic | Patients |
|---|---|
| Age, Continuous | 34.70 years |
| Sex: Female, Male Female | 192 Participants |
| Sex: Female, Male Male | 687 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,305 |
| serious Total, serious adverse events | 34 / 1,305 |
Outcome results
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.
Time frame: first visit, 6 months, and 12 months
Population: Number of patients with self-questionnaire responses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients | Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) | Proper usage at all visits (no misuse) | 131 participants |
| Patients | Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) | Misuse at M12 only | 20 participants |
| Patients | Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) | Misuse at M6 only | 15 participants |
| Patients | Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) | Misuse at D1 only | 38 participants |
| Patients | Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) | Misuse at M6 and M12 only | 19 participants |
| Patients | Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) | Misuse at D1 and M12 only | 24 participants |
| Patients | Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) | Misuse at D1 and M6 only | 34 participants |
| Patients | Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) | Misuse at all visits | 151 participants |
| Patients | Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) | Missing Data | 448 participants |
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.
Time frame: first visit, 6 months, and 12 months
Population: All eligible patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients | Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician. | Proper usage at all visits (no misuse) | 206 participants |
| Patients | Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician. | Misuse at M12 only | 37 participants |
| Patients | Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician. | Misuse at M6 only | 37 participants |
| Patients | Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician. | Misuse at D1 only | 134 participants |
| Patients | Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician. | Misuse at M6 and M12 only | 52 participants |
| Patients | Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician. | Misuse at D1 and M12 only | 49 participants |
| Patients | Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician. | Misuse at D1 and M6 only | 72 participants |
| Patients | Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician. | Misuse at all visits | 407 participants |
| Patients | Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician. | Missing Data | 295 participants |
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.
Time frame: first visit, 6 months, and 12 months
Population: Number of patients analyzed for the consequence, at each visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | psychiatric problems (n=1288/1133/1022) | 504 participants |
| Patients | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | other psychiatric problems (n=487/355/326) | 28 participants |
| Patients | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | delirium/hallucinations (n=499/358/327) | 26 participants |
| Patients | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | nutritional deficiency (n=1288/1134/1022) | 99 participants |
| Patients | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | sleep disturbances (n=500/360/327) | 336 participants |
| Patients | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | schizophrenia (n=499/356/326) | 18 participants |
| Patients | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | depression (n=502/359/325) | 230 participants |
| Patients | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | abscesses (n=1288/1134/1022) | 41 participants |
| Patients | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | suicide attempts (n=499/357/326) | 42 participants |
| Patients | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | dental problems (n=1287/1133/1022) | 459 participants |
| Patients | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | anxiety (n=500/360/326) | 335 participants |
| Patients | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | autistic withdrawal, inhibition (n=500/357/326) | 89 participants |
| Patients at 6 Month Visit | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | schizophrenia (n=499/356/326) | 15 participants |
| Patients at 6 Month Visit | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | anxiety (n=500/360/326) | 222 participants |
| Patients at 6 Month Visit | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | abscesses (n=1288/1134/1022) | 29 participants |
| Patients at 6 Month Visit | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | nutritional deficiency (n=1288/1134/1022) | 65 participants |
| Patients at 6 Month Visit | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | dental problems (n=1287/1133/1022) | 293 participants |
| Patients at 6 Month Visit | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | psychiatric problems (n=1288/1133/1022) | 364 participants |
| Patients at 6 Month Visit | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | depression (n=502/359/325) | 174 participants |
| Patients at 6 Month Visit | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | sleep disturbances (n=500/360/327) | 228 participants |
| Patients at 6 Month Visit | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | delirium/hallucinations (n=499/358/327) | 21 participants |
| Patients at 6 Month Visit | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | autistic withdrawal, inhibition (n=500/357/326) | 50 participants |
| Patients at 6 Month Visit | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | suicide attempts (n=499/357/326) | 14 participants |
| Patients at 6 Month Visit | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | other psychiatric problems (n=487/355/326) | 14 participants |
| Patients at 12 Month Visit | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | psychiatric problems (n=1288/1133/1022) | 329 participants |
| Patients at 12 Month Visit | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | suicide attempts (n=499/357/326) | 12 participants |
| Patients at 12 Month Visit | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | delirium/hallucinations (n=499/358/327) | 17 participants |
| Patients at 12 Month Visit | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | dental problems (n=1287/1133/1022) | 244 participants |
| Patients at 12 Month Visit | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | abscesses (n=1288/1134/1022) | 31 participants |
| Patients at 12 Month Visit | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | autistic withdrawal, inhibition (n=500/357/326) | 43 participants |
| Patients at 12 Month Visit | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | nutritional deficiency (n=1288/1134/1022) | 63 participants |
| Patients at 12 Month Visit | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | schizophrenia (n=499/356/326) | 15 participants |
| Patients at 12 Month Visit | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | depression (n=502/359/325) | 157 participants |
| Patients at 12 Month Visit | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | other psychiatric problems (n=487/355/326) | 18 participants |
| Patients at 12 Month Visit | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | sleep disturbances (n=500/360/327) | 200 participants |
| Patients at 12 Month Visit | Number of Patients Reporting Clinical Consequences of Engaging in Misuse | anxiety (n=500/360/326) | 200 participants |