At a glance
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Oxytocin Treatment of Alcohol Dependence: A Randomized, Placebo-Controlled Trial
In Brief
A Phase 2 clinical trial evaluating Intranasal Oxytocin and Placebo for Alcohol Dependence. Completed, enrolled 22 participants across 1 site.
Detailed Summary
Purpose: Test whether oxytocin treatment decreases drinking in people who have been consuming alcohol heavily for long periods and are physically and psychologically dependent on alcohol. Participants: 50 adults with alcohol dependence Procedures (methods): Oxytocin or placebo will be administered three times a day for the first 2 days followed by twice daily intranasal doses for the rest of the 12 weeks. Before, during and at the end of the trial, each subject will undergo evaluations including breathalyzer readings, rating withdrawal symptoms, interviews about amount of alcohol consumed since last clinic visit, subject self-ratings of anxiety, alcohol craving and, at some visits, laboratory measures (blood and urine) to monitor safety and alcohol/drug use. Following the active phase of the trial, subjects will be followed up at 4 weeks and 12 weeks to evaluate for post-medication safety and efficacy
Study Details
Timeline
Interventions
10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks
10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks