CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 43 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Intranasal Oxytocin 6 IUfrom 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/NCT02255357
NCT02255357Phase 3Completed

Investigation of the Effect of Intranasal Oxytocin on Relapse Risk in Cocaine-dependent Patients

New York State Psychiatric Institute·interventional·Posted Oct 2, 2014·Updated Jun 5, 2023

In Brief

A Phase 3 clinical trial evaluating Placebo and Intranasal Oxytocin for Cocaine Dependence. Completed, enrolled 43 participants across 2 sites.

Detailed Summary

This proposal describes a combined laboratory and clinical trial preliminary investigation to advance medication development for cocaine dependence. The main objective is to test whether intranasal Oxytocin could reduce relapse risk by reducing stress sensitivity. To measure the stress sensitivity, this study will evaluate a new stress challenge: a) Intranasal desmopressin, a vasopressin analog, will be used an endocrine stressor; its effects will be evaluated by serial measurements of serum Adrenocorticotropin hormone (ACTH), and self reports; b) if pretreatment with intranasal oxytocin dampens the ACTH and subjective response to intranasal desmopressin. These measures will be tested during a 7-day inpatient abstinence induction hospitalization. For those patients with family and work obligations, an outpatient abstinence induction procedure is available. The response to the desmopressin challenge will be compared to a cohort of matched control subjects. After abstinence induction, cocaine dependent patients enter a 6-week, double blind, randomized, placebo-controlled trial of 24 IU of intranasal oxytocin vs. placebo, to monitor if this reduces the relapse risk.

Study Details

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

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 2, 2014
Enrollment StartMar 1, 2015
Primary CompletionFeb 14, 2018
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 11.8 years ago

Interventions

Placebodrug

Solution containing only the excipients of the original solution without Oxytocin.

Intranasal Oxytocindrug

solution containing Oxytocin 6 IU/0.1cc or per puff is used in this arm