Cocaine Opioid Oxytocin Option - Limited (COOOL)

May 17, 2019 updated by: Joshua Woolley, University of California, San Francisco

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • San Francisco General Hospital Opiate Treatment Outpatient Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients 1
Participants will receive intranasal oxytocin 40 International Units (IU).
Drug: Oxytocin
Other Names:
  • oxytocin nasal spray, Syntocinon
Placebo Comparator: Patients 2
Participants will receive 40 International Units of intranasal placebo.
Drug: Placebo
Other Names:
  • placebo nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with non-serious and serious adverse events
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Christopher S Stauffer, MD, University of California, San Francisco
  • Study Director: Joshua Woolley, MD, PhD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 3, 2014

First Submitted That Met QC Criteria

January 3, 2014

First Posted (Estimate)

January 7, 2014

Study Record Updates

Last Update Posted (Actual)

May 21, 2019

Last Update Submitted That Met QC Criteria

May 17, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-12534

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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