E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of opioid dependence
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Behandlung von Opioidabhängigkeit |
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E.1.1.1 | Medical condition in easily understood language |
Treatment of opioid dependence |
Behandlung von Opioidabhängigkeit |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Behaviours [F01] |
MedDRA Classification |
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 |
To evaluate the appropriate ratio of morphine and naloxone to suppress the pleasurable effects of intravenous morphine and precipitate withdrawal reactions. |
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E.2.2 | Secondary objectives of the trial |
Assessment of individual physiological variables and symptoms and vital signs during study drug administration at various time points. Assessment of safety including adverse events, clinical laboratory results and vital signs.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male, over the age of 18 years - meet DSM-IV criteria for the diagnosis of opioid dependence currently undergoing morphine mainteinance treatment, - with a history of regular opioid abuse, - under opioid maintenance treatment for opioid abuse with morphine (occasionally injecting heroin) with a constant dose for ≥ 1 month, - in good health and have venous access sufficient for i.v. drug administration - with assessed normal QTc time (Bazzett corrected <500ms), - negative urine test (except for THC- tetrahydrocannabinol, “marijuana” and opioids) - agree to be admitted to the inpatient research unit for a minimum of 7 days, and be able to complete all protocol-specified assessments, - signed written informed consent. |
Einschlusskriterien: - Männlich, über 18 Jahre. - Opioidabhängigkeit entsprechend DSM-IV, unter aktueller Substitutionstherapie mit Morphin. bekannter, regelmäßiger Opioid Mißbrauch. - Substitutionstherapie für Drogenabhängige mit Morphin (gelegentlicher Heroinkonsum), konstante Dosierung für ≥ 1 Monat. - im guten Gesundheitszustand und ausreichenden venösen Zugang für i.v. Verabreichungen. - normale QTc Zeit. - neg. Drogenharntest (Ausnahme: THC , Marijuana und Opioide). - Patienteneinwilligung 7 Tage stationär aufgenommen zu werden und sich allen protokollspezifischen Untersuchungen zu unterziehen. - Unterzeichnete Einwilligungserklärung.
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E.4 | Principal exclusion criteria |
- with clinically significant somatic illnesses (except stable chronic hepatitis), - with acute psychotic illnesses, i.e. known schizophrenia, major depression with suicidal intent, - with opioid maintenance treatment with morphine at variable doses or for a period of < 1 month, - with daily alcohol consumption of > 100 g during the last 4 weeks, - with cocaine dependence, - showing contraindications to morphine (known hypersensitivity to opioids, restricted respiratory function, serious impairment of liver and/or kidney function, inter alia), - uncooperative patients, unwilling to follow instructions by the Investigator, - patients scheduled for any major surgery or intervention, which would fall within the study period, - patients who have participated in another clinical research study involving a new chemical entity within 3 months of study entry, - patients who, in the opinion of the Investigator, are unsuitable to participate in the study for any other reason not mentioned in the inclusion and exclusion criteria, - with imprisonment or under criminal prosecution for the following 4 week-period, - with incapacitation and court appointment. - with documented (ultrasound or right heart catheter) heart failure (NYHA >II) - with documented (ECG) history of cardiac arrhythmia |
Ausschlusskriterien: - klinisch signifikante somatische Erkrankung (Ausnahme: stabile chronische Hepatitis). - akute psychotischer Erkrankung (z. B Schizophrenie, ..). - unter Substitutionstherapie für Drogenabhängige mit Morphin , variabler Dosierung für < 1 Monat. - mit einem täglichen Alkoholkonsum von > 100g während der letzten 4 Wochen. - Kokainabhängigkeit. - Kontraindikationen gegenüber Morphin (Hypersensitivität, eingeschränkte respiratorische Funktion, …). - Mangelnde Kooperationsbereitschaft mit dem Studienteam - Patienten mit einem geplanten größeren Eingriff bzw. Intervention während der Studiendauer - Behandlung mit einer nicht zugelassenen Medikation innerhalb von 3 Monaten vor Studienbeginn - Patienten, die aus der Sicht des Prüfers aufgrund von weiteren Gründen (welche nicht in den Aus- und Einschlusskriterien enthalten sind) nicht an dieser Studie teilnehmen sollten - Freiheitsstrafe oder Strafverfolgung für die nächsten 4 Wochen - Entmündigung oder Strafverfahren |
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E.5 End points |
E.5.1 | Primary end point(s) |
Signs and symptoms of opioid-withdrawal at various time points. |
Messung der Entzugssymtomatik |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
0 to 120 minutes |
0 bis 120 Minuten |
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E.5.2 | Secondary end point(s) |
- Pupil diameter and vital signs at various time points.
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Pupillendurchmesser und Vitalparameter zu verschiedenen Zeitpunkten. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
0 to 120 minutes |
0 bis 120 Minuten |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
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 | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |