Effects of the neuropeptide Oxytocin on opioide withdrawal symptoms

Phase 1

• Conditions: Individuals with opioid dependence who are voluntary inpatients from detoxification unit are investigated. The opioid withdrawal symptome are observed.; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2010-023208-29-DE
• Lead Sponsor: Rheinische Friedrich-Wilhelms-University of Bonn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-20
• Last Update Posted: 31 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 80

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to evaluate whether intranasal oxytocin application attenuates withdrawal symptoms in patients with opioid dependence. ;Secondary Objective: The concentration of oxytocin, vasopressin and cortisol is observed over the period of detoxification (secondary end point). ;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.;Timepoint(s) of evaluation of this end point: The primary timepoint will be evaluated after inclusion of 80 subjects.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The concentration of oxytocin, vasopressin and cortisol during the period of detoxification is measured. ;Timepoint(s) of evaluation of this end point: The secondary endpoint will be evaluated after inclusion of 80 individuals.