We receive many emails enquiring about progress. As answering these takes time away from processing submissions, please email only if absolutely necessary. We are working hard to process registration and update requests as quickly as possible.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intranasal oxytocin for the treatment of alcohol dependence
Scientific title
The effect of intranasal oxytocin on alcohol cravings and withdrawal in patients diagnosed with alcohol dependence
Secondary ID [1] 252677 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol Dependence 258170 0
Condition category
Condition code
Mental Health 258352 258352 0 0

Study type
Description of intervention(s) / exposure
40 international units of oxytocin intranasally twice per day for 4 weeks.
Intervention code [1] 257191 0
Treatment: Drugs
Comparator / control treatment
All placebo administration is twice per day for 4 weeks. It is exactly the same as the oxytocin administration condition. Placebo is administered intranasally and consists of the preservatives found in the active oxytocin nasal spray (i.e., chlorobutanol hemihydrate, E216, and E218).
Control group

Primary outcome [1] 259204 0
Time Line Follow Back includes the number of days of heavy drinking days over 28 days; the percentage of drinking days (the number of drinking days reported during that period of 28 days divided by the number of days for which data are available); and number of drinks per day over the 28 days (the total number of drinks reported during the period divided by the number of days on which consumption of one or more drinks was reported).
Timepoint [1] 259204 0
Baseline, drug administration completion (4-week), one-month follow-up (8-week).
Secondary outcome [1] 265579 0
Self Reports of depression, sleep and disability, including the Depression Anxiety Stress Scale - 21, K-10,
Social Interaction Anxiety Scale, Pittsburgh Sleep Quality Index and the World Health Organisation Disability Assessment Schedule - II
Timepoint [1] 265579 0
Baseline, drug administration completion (4-week), one-month follow-up (8-week).
Secondary outcome [2] 265580 0
Reduction in neurocognitive and psychosocial impairment using the Reading the Mind in the Eyes task, Eye-gaze and social cognition.
Timepoint [2] 265580 0
Baseline, drug administration completion (4-week), one-month follow-up (8-week).
Secondary outcome [3] 265583 0
Blood plasma hormone levels including oxytocin, vasopressin, cortisal
Timepoint [3] 265583 0
Baseline, 4-week, 8-week
Secondary outcome [4] 265589 0
Psychophysiology assessments of baseline heart rate and Electroencephalography responses.
Timepoint [4] 265589 0
Baseline, 4-week, 8-week

Key inclusion criteria
Primary diagnosis of alcohol dependence according to the Diagnostic and Statistical Manual of Mental Disorders (DSM) Edition 4.
Minimum age
18 Years
Maximum age
80 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
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


Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Advertisement and word-of-mouth. Allocation randomised by compounding chemist. The person deciding on participant inclusion will use numbered containers to allocate medication.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257642 0
Name [1] 257642 0
University of Sydney
Address [1] 257642 0
100 Mallett St
Brain and Mind Research Institute (BMRI)
University of Sydney, New South Wales (NSW) 2050
Country [1] 257642 0
Primary sponsor type
University of Sydney
100 Mallett St
University of Sydney, NSW 2050
Secondary sponsor category [1] 256864 0
Name [1] 256864 0
Address [1] 256864 0
Country [1] 256864 0

Ethics approval
Ethics application status
Ethics committee name [1] 259656 0
University of Sydney Human Ethics Committee
Ethics committee address [1] 259656 0
Level 6
Jane Foss Russell Building G02
The University of Sydney NSW 2006
Ethics committee country [1] 259656 0
Date submitted for ethics approval [1] 259656 0
Approval date [1] 259656 0
Ethics approval number [1] 259656 0

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 31637 0
A/Prof Adam Guastella
Address 31637 0
Brain & Mind Research Institute, 94 Mallett St, Camperdown, NSW 2050
Country 31637 0
Phone 31637 0
+61 2 9351 0539
Fax 31637 0
Email 31637 0
Contact person for public queries
Name 14884 0
A/Prof Adam Guastella
Address 14884 0
Brain & Mind Research Institute, 94 Mallett St, Camperdown, NSW 2050
Country 14884 0
Phone 14884 0
Fax 14884 0
Email 14884 0
Contact person for scientific queries
Name 5812 0
A/Prof Adam Guastella
Address 5812 0
Brain & Mind Research Institute, 94 Mallett St, Camperdown, NSW 2050
Country 5812 0
Phone 5812 0
Fax 5812 0
Email 5812 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary