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Cocaine Opioid Oxytocin Option - Limited (COOOL)

Primary Purpose

Opioid Use Disorder, Cocaine Use Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Placebo
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Opioid Use Disorder focused on measuring addiction, oxytocin, tolerability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • San Francisco General Hospital Opiate Treatment Outpatient Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Patients 1

Patients 2

Arm Description

Participants will receive intranasal oxytocin 40 International Units (IU).

Participants will receive 40 International Units of intranasal placebo.

Outcomes

Primary Outcome Measures

Number of patients with non-serious and serious adverse events

Secondary Outcome Measures

Full Information

First Posted
January 3, 2014
Last Updated
May 17, 2019
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT02028533
Brief Title
Cocaine Opioid Oxytocin Option - Limited
Acronym
COOOL
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder, Cocaine Use Disorder
Keywords
addiction, oxytocin, tolerability

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients 1
Arm Type
Active Comparator
Arm Description
Participants will receive intranasal oxytocin 40 International Units (IU).
Arm Title
Patients 2
Arm Type
Placebo Comparator
Arm Description
Participants will receive 40 International Units of intranasal placebo.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
oxytocin nasal spray, Syntocinon
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo nasal spray
Primary Outcome Measure Information:
Title
Number of patients with non-serious and serious adverse events
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher S Stauffer, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joshua Woolley, MD, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Director
Facility Information:
Facility Name
San Francisco General Hospital Opiate Treatment Outpatient Program
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Cocaine Opioid Oxytocin Option - Limited

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