Intranasal oxytocin for the treatment of alcohol dependence

Phase 3

Completed

• Conditions: Alcohol Dependence; Mental Health - Addiction

• Registration Number: ACTRN12610001061022
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).[Baseline, drug administration completion (4-week), one-month follow-up (8-week).]

Secondary Outcome Measures

Name	Time	Method
Self Reports of depression, sleep and disability, including the Depression Anxiety Stress Scale - 21, K-10, <br>Social Interaction Anxiety Scale, Pittsburgh Sleep Quality Index and the World Health Organisation Disability Assessment Schedule - II[Baseline, drug administration completion (4-week), one-month follow-up (8-week).];Reduction in neurocognitive and psychosocial impairment using the Reading the Mind in the Eyes task, Eye-gaze and social cognition.[Baseline, drug administration completion (4-week), one-month follow-up (8-week).];Blood plasma hormone levels including oxytocin, vasopressin, cortisal[Baseline, 4-week, 8-week];Psychophysiology assessments of baseline heart rate and Electroencephalography responses.[Baseline, 4-week, 8-week]