Cocaine Opioid Oxytocin Option - Limited

Phase 1CompletedNCT02028533

University of California, San Francisco30 enrolled

Overview

This is a pilot feasibility study assessing the tolerability of chronic administration of intranasal oxytocin to patients receiving methadone at an opioid replacement clinic who are actively using cocaine.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Opioid Use Disorder Cocaine Use Disorder

Interventions

OxytocinDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Enrolled as a patient in the San Francisco General Hospital Opioid Treatment Outpatient Program * Stable dose of methadone for at least the past two weeks * At least one routine urine toxicology screen positive for cocaine in the past month Exclusion Criteria: * Positive urine pregnancy test * Use of illicit drugs in the past month (with the exception of cocaine or cannabis) * Currently meets Diagnostic and Statistical Manual-5 (DSM-V) criteria for severe major depressive disorder with suicidal thoughts or actions * History of psychotic or moderate-severe alcohol use disorder as defined by DSM-V criteria * Severe neuropsychological disorder, brain trauma, epilepsy * Sensitivity to preservatives (in particular E 216, E 218 and chlorobutanol hemihydrate) * Nasal obstruction, discharge, or bleeding * Habitually drinks large volumes of water * Taking testosterone, estrogen/progesterone supplement, or serotonin-1a receptor agonists/antagonists

Locations (1)

San Francisco General Hospital Opiate Treatment Outpatient Program

San Francisco, California, United States

Outcomes

Primary Outcomes

Number of patients with non-serious and serious adverse events

Time frame: 3 weeks

Data from ClinicalTrials.gov

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