A Randomized Controlled Trial of Oxytocin Nasal Spray for Alcohol Dependence

INTERVENTION: The study involves assessing the effect of oxytocin nasal spray (20 international units sprayed into each nostril, twice a day for 12 weeks) for alcohol dependence through a double blinded randomised placebo controlled trial. Participants will be randomised to receive either an active oxytocin nasal spray or inactive placebo nasal spray. Participants will be a given a drug diary to track adherence and potential side effects, and drug bottles will be weight before and after treatment by the study coordinator. Oxytocin levels will be measured in the blood at pre and post treatment. To ensure adequate follow‐up data, participants will be reimbursed for their time for 1 month and 6 month follow up, with a $50 gift voucher. CONDITION: alcohol dependence PRIMARY OUTCOME: Proportion of participants with a reduction in number of heavy drinking days at 12 weeks post commencement of treatment, 16 weeks post commencement of treatment and 6 months post commencement of treatment. A heavy drinking day is defined as a day when 4 or more drinks are consumed. This will be assessed using the drug diary and the timeline followback method. SECONDARY OUTCOME: Number of participants with improved composite scores in executive function tests including learning and memory using the Cambridge Neuropsychological Test Automated Battery, Rey auditory verbal learning test and Trail Making Test. Proportion of participants which show a change in amount of metabolite GABA using magnetic resonance imaging (MRI) Proportion of participants which show a change in amount of metabolite N‐acetyl‐aspartate using magnetic resonance imaging (MRI) Proportion of participants with a reduction in craving assessed using the Obsessive Compulsive Drinking Scale (OCDS) at 12 weeks post commencement of treatment, 16 weeks post commencement of treatment and 6 months post commencement of treatment INCLUSION CRITERIA: • Aged between 18 and 65 years of age • Meet the International Classification of Diseases, 10th Revision (ICD10), criteria for alcohol dependence • Fluency in English • Ability to give informed consent