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
Phase:
Phase 2
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)