E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013663 |
E.1.2 | Term | Drug dependence |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the study is to demonstrate that direct Suboxone induction is not inferior to a Subutex-to-Suboxone induction as measured by response rate at Day 3. The response rate will be assessed by determining the proportion of subjects in each group who receive the scheduled dose of Suboxone at the Day 3 study visit. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study will assess the overall clinical response to Suboxone as a function of the induction strategy by comparing the response of subjects inducted directly with Suboxone to those inducted with a Subutex-to-Suboxone procedure on 1) illicit opioid and non-opioid drug use as measured by urine drug screening (UDS), 2) illicit opioid and non-opioid drug use as measured by self-report on the Substance Use Inventory (SUI), 3) self-reported opioid withdrawal symptoms as measured by the Subjective Opiate Withdrawal Scale (SOWS), 4) observer-rated opioid withdrawal symptoms as measured by the Objective Opiate Withdrawal Scale (OOWS), 5) addiction-related problem profiles as measured by the Addiction Severity Index (ASI)–Lite, 6) compliance rate, and 7) response rate. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subjects must be males or non-pregnant, non-lactating females. 2. Subjects must be at least 18 years of age, of either sex, and any race. 3. Subjects (and/or the parent or guardian for subjects under the age of legal consent or who otherwise are unable to provide independent consent) must demonstrate willingness to participate in the study and to adhere to dose and visit schedules. 4. Subjects must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria(24) for opioid dependence. 5. Subjects must have a methadone- and buprenorphine-negative UDS result prior to randomization. 6. Each subject must confirm that he or she is practicing adequate contraception. Female volunteers of childbearing potential (including women who are less than 1 year postmenopausal and women who will be sexually active during the study) must agree to use a medically accepted method of contraception or must be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 30 days after stopping the medication. Women who have been postmenopausal for ≥1 year (ie, women who have experienced 12 or more consecutive months of amenorrhea) will be exempted from the requirement to use contraception during the study. Acceptable methods include hormonal implants, injectables, combined oral contraceptives, hormonal intrauterine devices and surgical sterilization (eg, hysterectomy or tubal ligation). 7. Female subjects of childbearing potential must have a negative urine beta– human chorionic gonadotropin (beta-hCG) test prior to enrollment in the study.
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E.4 | Principal exclusion criteria |
1. Subjects for whom treatment with either Subutex or Suboxone as required in the protocol would be inconsistent with national labeling. 2. Subjects who are unwilling or unable to comply with the requirements of the protocol (eg, pending incarceration) or are in a situation or condition that, in the opinion of the investigator, may interfere with participation in the study. 3. Subjects who are participating in any other clinical study in which medication(s) are being delivered. 4. Subjects with known allergy or sensitivity to buprenorphine or naloxone. 5. Subjects who are on the staff, affiliated with, or a family member of the staff personnel directly involved with this study. 6. Subjects with serious untreated Axis I DSM-IV-TR psychiatric co-morbidity (eg, those who are actively suicidal or homicidal, have untreated schizophrenia, etc). Polysubstance abuse or dependence will not exclude subjects except in the case of unauthorized and significant benzodiazepine use requiring medical detoxification or alcohol dependence requiring medical detoxification. 7. HIV-positive subjects with clinical acquired immunodeficiency syndrome (AIDS). 8. Methadone or buprenorphine maintenance or detoxification within 30 days of enrollment.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the response rate to treatment assignment, which will be assessed by determining the proportion of subjects in each group who receive the scheduled dose of Suboxone at the Day 3 study visit. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Double Dummy, third party non-blinded |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 32 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last subject completed or discontinued. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |