Cocaine Opioid Oxytocin Option - Limited (COOOL)

University of California San Francisco (UCSF)

Status and phase

Completed

Phase 1

Conditions

Opioid Use Disorder

Cocaine Use Disorder

Treatments

Drug: Placebo

Drug: Oxytocin

Study type

Interventional

Funder types

Other

Identifiers

NCT02028533

13-12534

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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