drugset / Trial / NCT01212185

Oxytocin Treatment of Alcohol Withdrawal

NCT01212185

Phase 1 Completed 14 enrolled University of North Carolina, Chapel Hill
RandomizedParallel-groupTriple-blindTreatment

Summary

Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, is effective in decreasing alcohol withdrawal symptoms, the number of bouts of withdrawal requiring standard medication treatment (lorazepam) and the amount of lorazepam required to control withdrawal bouts in individuals undergoing medical detoxification. Also, determine rates of subject recruitment and retention in the inpatient setting. Participants: 80 alcohol dependent patients, 18-65 years of age, admitted for medical detoxification. Procedures (methods): Subjects will be inpatients undergoing medical detoxification from alcohol. Oxytocin or placebo will be administered in a nasal spray twice daily in a randomized, double blind manner for three days. Withdrawal symptoms will be measured routinely at q4 hours and prn for length of hospital stay. Lorazepam will be given whenever withdrawal symptoms increase above specific parameters.

Timeline

Start
2010-07
Primary completion
2011-03
Completion
2011-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxytocin Peptide 24 iu Intranasal

Indications