CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Intranasal Oxytocin Spray +1 moredrug
Likely dose
Intranasal Oxytocin Spray 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/NCT02548728
NCT02548728Phase 2Completed
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Oxytocin Treatment of Opioid Dependence

University of North Carolina, Chapel Hill·interventional·Posted Sep 14, 2015·Updated Aug 7, 2019

In Brief

A Phase 2 clinical trial evaluating Intranasal Oxytocin Spray and Placebo for Opioid Dependence and Opioid Withdrawal. Completed, enrolled 12 participants across 1 site.

Detailed Summary

Purpose: The purpose of this research study is to learn whether oxytocin treatment decreases use of and cravings for opioids (narcotics) in people who have been using opioids heavily for long periods of time and are unable to stop on their own. Participants: Patients meeting DSM-IV-TR criteria for opioid dependence. Procedures (methods): Subjects will have standard medications available for withdrawal symptoms from opioids and standard psychosocial interventions available in the inpatient setting. In addition, subjects will self-administer intranasal test treatments 3 times daily.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Dependence, Opioid Withdrawal
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 14, 2015
Enrollment StartFeb 1, 2016
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.8 years ago

Interventions

Intranasal Oxytocin Spraydrug

10 insufflations (40IU of oxytocin total) given three times on day of enrollment and then twice daily for 4 days

Placebodrug

10 insufflations (40IU of placebo, same solution as active treatment minus oxytocin) given three times on day of enrollment and then twice daily for 4 day