CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
Intranasal oxytocin +1 moredrug
Likely dose
Intranasal placebo 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/NCT03016598
NCT03016598Phase 2Completed

6-week Trial of Oxytocin for Co-occurring Cocaine and Opioid Use Disorders

VA Office of Research and Development·interventional·Posted Jan 10, 2017·Updated Jun 10, 2021

In Brief

A Phase 2 clinical trial evaluating Intranasal oxytocin and Intranasal placebo for Stimulant Use & Co-occuring Opioid Use Disorders. Completed, enrolled 42 participants across 3 sites.

Detailed Summary

This study will investigate the effects of intranasal administration of oxytocin, a social neuropeptide, on reducing stimulant use, enhancing therapeutic engagement, and susceptibility to stress-induced relapse in Veterans with stimulant use disorders and enrolled in opioid replacement therapy (ORT) program for co-occurring opioid use disorder (OUD).

Study Details

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

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 10, 2017
Enrollment StartJan 26, 2018
Primary CompletionFeb 14, 2020
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.5 years ago

Interventions

Intranasal oxytocindrug

Each Veteran with a stimulant use disorder, receiving MMT for OUD will receive a oxytocin nasal spray 40 International Units (IU) to be self administered twice daily over 6 weeks while in the MMT program. The veteran will come in for a total of 7 weekly visits. At baseline and during the last visit the veteran will complete at Trier Social Stress Test (TSST), and psychophysiological and biomarkers of stress will be collected. At every weekly visit a urine sample and self-reported drug use will be collected and therapy attendance will be recorded.

Intranasal placebodrug

Each Veteran with a stimulant use disorder, receiving MMT for OUD will receive a placebo nasal spray 40IU to be self administered twice daily over 6 weeks while in the MMT program. The veteran will come in for a total of 7 weekly visits. At baseline and during the last visit the veteran will complete at Trier Social Stress Test (TSST), and psychophysiological and biomarkers of stress will be collected. At every weekly visit a urine sample and self-reported drug use will be collected and therapy attendance will be recorded.