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. MedDRA version: 20.0 Level: LLT Classification code 10057379 Term: Addiction relapse System Organ Class: 100000004873 MedDRA version: 20.0 Level: LL
Conditions
Interventions
Trade Name: Syntocinon
Product Name: Syntocinon-Spray
Product Code: Oxytocin
Pharmaceutical Form: Nasal spray
INN or Proposed INN: Oxyto
Sponsors
University of Surrey
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: 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. , ; 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) ;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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. ; 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 | — |
Countries
United Kingdom
Contacts
Public ContactRIGO
University of Surrey
Outcome results
None listed