Cocaine Opioid Oxytocin Option - Limited

Chronic Intranasal Oxytocin as an Adjunct to Methadone Maintenance Treatment in Patients With Co-occuring Opioid Use Disorder and Cocaine Use: A 2-week Pilot Study

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02028533

Acronym

COOOL

Enrollment

Registered

2014-01-07

Start date

2014-07-31

Completion date

2014-12-31

Last updated

2019-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cocaine Use Disorder, Opioid Use Disorder

Keywords

addiction, oxytocin, tolerability

Brief 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.

Interventions

DRUGOxytocin

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Number of patients with non-serious and serious adverse events	3 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026