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Intranasal oxytocin for the treatment of alcohol dependence

The effect of intranasal oxytocin on alcohol cravings and withdrawal in patients diagnosed with alcohol dependence

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610001061022
Enrollment
35
Registered
2010-12-02
Start date
2010-09-20
Completion date
2012-05-14
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

This double-blind, randomised, placebo controlled trial will examine the safety and efficacy of intranasal oxytocin for the treatment of alcohol dependence. It is hypothesised that participants randomised to the oxytocin condition, compared to participants randomised to the placebo condition will have a higher rate of treatment completion, experience reduced number, severity, and duration of alcohol withdrawal symptoms and will report fewer days of alcohol use at one month follow-up.

Interventions

Sponsors

University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Primary diagnosis of alcohol dependence according to the Diagnostic and Statistical Manual of Mental Disorders (DSM) Edition 4.

Exclusion criteria

Epilepsy Severe depression with suicidal thoughts and/ or actions Other primary drug addiction (other than nicotine, or cannabis) Not stable on psychotropic medication (i.e., have been taking the medication for less than 4 weeks) Currently receiving psychological or pharmacological treatment for substance use problems Kidney Disease- (i.e., kidney stones, recurrent bladder infections, or known kidney failure). Severe liver disease (e.g., decompensated hepatic failure) Sensitivity to preservatives (in particular E 216, E 218 and chlorobutanol hemihydrate). Nasal obstruction, discharge, or bleeding Cardiovascular problems (e.g., heart disease, history of heart attacks), high blood pressure (hypertension) Habitually drink large volumes of water Pregnancy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026