Trial of oxytocin for the treatment of emotional withdrawal symptoms and for relapse prevention in abstinent heroin dependent individuals

Phase 1

• Conditions: 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: LLT Classification code 10001126 Term: Addiction any drug System Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2014-002708-26-GB
• Lead Sponsor: niversity of Surrey

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-06
• Study Completion: 2017-10-06
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 3

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified