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Trial registered on ANZCTR


Registration number
ACTRN12610001061022
Ethics application status
Approved
Date submitted
11/09/2010
Date registered
2/12/2010
Date last updated
6/11/2013
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
None
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
Addiction

Intervention/exposure
Study type
Interventional
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
Placebo

Outcomes
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

Eligibility
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
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
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
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 257642 0
University
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
Australia
Primary sponsor type
University
Name
University of Sydney
Address
100 Mallett St
BMRI
University of Sydney, NSW 2050
Country
Australia
Secondary sponsor category [1] 256864 0
None
Name [1] 256864 0
Address [1] 256864 0
Country [1] 256864 0

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 259656 0
Approval date [1] 259656 0
29/04/2010
Ethics approval number [1] 259656 0
12055

Summary
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

Contacts
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
Australia
Phone 31637 0
+61 2 9351 0539
Fax 31637 0
Email 31637 0
adam.guastella@sydney.edu.au
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
Australia
Phone 14884 0
+61293510539
Fax 14884 0
Email 14884 0
adam.guastella@sydney.edu.au
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
Australia
Phone 5812 0
+61293510539
Fax 5812 0
Email 5812 0
adam.guastella@sydney.edu.au

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