drugset / Trial / NCT02251912

Oxytocin Treatment of Alcohol Dependence

NCT02251912 ↗

RandomizedParallel-groupDouble-blindTreatment

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

Timeline

Start
2015-07
Primary completion
2016-09
Completion
2016-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxytocin Peptide 40 iu Intranasal

Indications