Effects of the neuropeptide Oxytocin on opioide withdrawal symptoms

Effects of Oxytocin on opioide withdrawal symptoms

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023208-29-DE

Enrollment

Registered

2010-12-20

Start date

2011-08-02

Completion date

Unknown

Last updated

2020-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Individuals with opioid dependence who are voluntary inpatients from detoxification unit are investigated. The opioid withdrawal symptome are observed.

Interventions

Trade Name: Syntocinon Product Name: Syntocinon Pharmaceutical Form: Nasal spray INN or Proposed INN: Oxytocin CAS Number: 50-56-6 Current Sponsor code: SUB09580MIG Other descriptive name: OXYTOCIN Co

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Germany

Contacts

Public ContactDepartment of Psychiatry

University of Bonn

r.hurlemann@googlemail.com4922828715057

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026