E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Opioid dependence. The study will be investigating the efficacy of Syntocinon (oxytocin) on treating the withdrawal symptoms and cravings that opioid (e.g. almost always heroin) dependent individuals experience following detoxification. |
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E.1.1.1 | Medical condition in easily understood language |
Dependence to opioids such as heroin. Anxiety, craving, depression and social withdrawal symptoms associated with abstinence from opioid use (mostly heroin)in opioid dependent individuals |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10057379 |
E.1.2 | Term | Addiction relapse |
E.1.2 | System Organ Class | 100000004873 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001126 |
E.1.2 | Term | Addiction any drug |
E.1.2 | System Organ Class | 100000004873 |
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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 will be to investigate the efficacy of oxytocin (Syntocinon) in retaining post-detoxification opioid (e.g. heroin) dependent individuals in inpatient rehabilitation programme and in preventing relapse to opioids (e.g. heroin) or other drug use.
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E.2.2 | Secondary objectives of the trial |
The secondary objective will be to investigate the efficacy of oxytocin (Syntocinon) in reducing opioid (e.g. heroin) craving, anxiety, depression, social anxiety, sleep disturbances and in enhancing social cognition, quality of life. , |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Primary diagnosis of opioid dependence according to DSMIV criteria 2) Males and non-lactating, non-pregnant females, aged 18-65 years. 3) Patients must be willing and able to give informed consent 4) Patients must have understanding of English 5) Patients are required to have completed opiate detoxification programme at Windmill House and remain opiate free before the start of the study. These patients will continue with a specific opiate free inpatient programme at Windmill House. The programme runs 6 days a week, with daily groups comprising a mixture of cognitive behaviour therapy (CBT), psychodynamic and recovery related groups.
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E.4 | Principal exclusion criteria |
1) Severe psychosis, Bipolar Affective Disorder I, severe depression with suicidal ideation and intention, brain trauma or other severe neurological disorders (e.g. pan-hypopituitarism). 2) Taking anxiolytics antipsychotics, sedatives, opioids for pain management during post opiate detoxification. 3) Pregnant females and lactating mothers 4) History of severe kidney disease 5) History of cardiovascular disease (heart disease, heart attacks, abnormally high blood pressure) 6) Habitual drinking of large volumes of water 7) Nasal bleeding 8) Any other condition that in the judgement of the investigator would preclude participation |
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E.5 End points |
E.5.1 | Primary end point(s) |
Retention rates in rehabilitation programme Rates of subjects relapsing to drug use (urine positives for opioid and illicit drug metabolites, self reporting) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Retention rates in rehabilitation programme at appx. 2 weeks from the first dose of Syntocinon/placebo administration and rates of subjects relapsing to drug use (urine positives for opioid and illicit drugs metabolites, self reporting) at specific time points from the first dose of Syntocinon/placebo administration (e.g. 2 and 6 weeks). |
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E.5.2 | Secondary end point(s) |
Measures of withdrawal symptoms severity, opioid craving, anxiety, depression, social anxiety, social cognition, sleep disturbances and salivary cortisol levels at the start (treatment day 2) and the end (treatment day 14) of the 2 week placebo/Syntocinon treatment period and 1 month after the end of the last dose of placebo/Syntocinon treatment. Measures of quality of life (wellbeing) at baseline and 1 month after the last dose of placebo/Syntocinon treatment. Activity/sleep profile before (i.e. from screening), during and after placebo/Syntocinon treatment up to 1 month after the end of the treatment. Exploratory: Urine metabolomic profiles upon admission, at baseline, at the start of placebo/Syntocinon treatment (treatment day 2), at the end of the 2 week placebo/Syntocinon treatment period (treatment day 14) and 1 month after the last dose of placebo/Syntocinon treatment. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Measures of withdrawal symptoms severity, opioid craving, anxiety, depression, social anxiety, social cognition, sleep disturbances and salivary cortisol levels at the start (treatment day 2) and the end (treatment day 14) of the 2 week placebo/Syntocinon treatment period and 1 month after the end of the last dose of placebo/Syntocinon treatment. Measures of quality of life (wellbeing) at baseline and 1 month after the last dose of placebo/Syntocinon treatment. Activity/sleep profile before (i.e. from screening), during and after placebo/Syntocinon treatment up to 1 month after the end of the treatment. Exploratory: Urine metabolomic profiles upon admission, at baseline, at the start of placebo/Syntocinon treatment (treatment day 2), at the end of the 2 week placebo/Syntocinon treatment |
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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 | 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 | Yes |
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 | 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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The trial will end when the last study patient completes the last study visit. Final analysis of the results will be completed once the trial has ended. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 21 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 21 |