CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Intranasal Oxytocin +1 moredrug
Likely dose
Intranasal Oxytocin 40IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02251912
NCT02251912Phase 2Completed

Oxytocin Treatment of Alcohol Dependence: A Randomized, Placebo-Controlled Trial

University of North Carolina, Chapel Hill·interventional·Posted Sep 29, 2014·Updated Aug 15, 2017

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 29, 2014
Enrollment StartJul 1, 2015
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.8 years ago

Interventions

Intranasal Oxytocindrug

10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks

Placebodrug

10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks