Cocaine Opioid Oxytocin Option - Limited

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Cocaine; Oxytocin

Criteria

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