E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Individuals with opioid dependence who are voluntary inpatients from detoxification unit are investigated. The opioid withdrawal symptome are observed. |
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E.1.1.1 | Medical condition in easily understood language |
Patients with opioiddependence who receive a qualified withdrawal treatment on the addiction ward of the Deprtment of Psychiatry, University of Bonn. |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
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 |
The primary objective of this study is to evaluate whether intranasal oxytocin application attenuates withdrawal symptoms in patients with opioid dependence. |
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E.2.2 | Secondary objectives of the trial |
The concentration of oxytocin, vasopressin and cortisol is observed over the period of detoxification (secondary end point). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• 80 Male volunteers with opioid dependency who are voluntary inpatients from detoxification unit • 18 to 65 years • Capable of legally effective informed condsent and persons not being in legal custody • Given written-informed consent to the study procedures
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E.4 | Principal exclusion criteria |
• Lack of legally effective informed consent • Contraindication of MRI • Axis I disorder • Acute polytoxikomania • Cerebrale abnormality (diagnosed by MRI) • status post organ transplantation • Known allergic to oxytoocin of alkyl-4-hydroxybenzoate • Consumption of large amounts of fluid before oxytocin application • Water and electrolyte dysbalance • Severe renal insufficiency • Decompensated cirrhosis of the liver (Ascites, vaiceal haemorrhage, encephalopathy)
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E.5 End points |
E.5.1 | Primary end point(s) |
The participants will finish the study after 20 days. The whole study will end after inclusion of 80 male volunteers. The primary endpoint is whether oxytocin reduces withdrawal symptoms during opioid detoxification. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary timepoint will be evaluated after inclusion of 80 subjects. |
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E.5.2 | Secondary end point(s) |
The concentration of oxytocin, vasopressin and cortisol during the period of detoxification is measured. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The secondary endpoint will be evaluated after inclusion of 80 individuals. |
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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 | No |
E.6.5 | Efficacy | No |
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 | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | Information not present in EudraCT |
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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The trial ends after inclusion of 80 subjects. The study ends per subjects after 20 days. |
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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 | 12 |
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 | 12 |
E.8.9.2 | In all countries concerned by the trial days | 0 |