None listed
Conditions
Brief summary
The project is a double blind, between subject, randomised controlled study. Specifically the study will assess the impact of OT on the number of heavy drinking days and alcohol craving. The study will also investigate the potential neuroprotective benefits of OT, by assessing learning and memory, executive functions and changes in neurometabolites measured through neuropsychological assessments and MRI. Participants will be recruited through the drug and alcohol centre at Royal Prince Alfred Hospital, as well as community recruitment through media and Facebook. They will be required to attend a screening and eligibility assessment and if eligible be randomised to receive placebo or OT nasal spray, which will need to be self-administered twice a day, for 12 weeks. Participants will be asked to return at 6 weeks (mid-treatment), 12 weeks (end of treatment), 1 month post follow-up, and 6 months post end of treatment for further follow-up. During the study, participants will be asked to complete a number of self-report questionnaires, undergo physiological, neuropsychological and neuroimaging assessments, as well as provide urine and blood sample.
Interventions
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 stud
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.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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
Exclusion criteria
• Women lactating, pregnant or childbearing potential who are not willing to avoid pregnancy during the study • Meet criteria for severe acute psychiatric disorders including psychosis or moderate/high risk for self-harm (suicidality) • Meet International Statistical Classification of Diseases and Related Health Problems (ICD-10) criteria for another substance dependence (other than nicotine, due to high comorbidity between these disorders • Currently participating in another substance use treatment • People with pending legal charges and potential incarceration • IQ below 75 (assessed using the Weschler Test of Adult Reading (WTAR) • Those who have severely compromised cardiac, hepatic or renal function (evidenced at medical examination) • Use of benzodiazepines
Outcome results
None listed