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Clinical Trials/EUCTR2014-002708-26-GB
EUCTR2014-002708-26-GB
Active, not recruiting
Phase 1

A randomised double blind placebo controlled pilot trial of oxytocin efficacy in treating detoxified opioid dependent individuals - Pilot RCT of oxytocin for the treatment of opioid dependence

niversity of Surrey0 sites3 target enrollmentNovember 6, 2014
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ConditionsOpioid 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: 100000004873MedDRA version: 20.0 Level: LLT Classification code 10001126 Term: Addiction any drug System Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
DrugsSyntocinon

Overview

Phase
Phase 1
Intervention
Not specified
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.
Sponsor
niversity of Surrey
Enrollment
3
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 6, 2014
End Date
October 6, 2017
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
niversity of Surrey

Eligibility 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

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

Outcomes

Primary Outcomes

Not specified

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