Cocaine Opioid Oxytocin Option - Limited | NCT02028533

Studies
Cocaine Opioid Oxytocin Option - Limited

NCT02028533

Sponsor

University of California, San Francisco

Status

Completed

Last Update Posted

May 21, 2019Actual

Enrollment

30Actual

Phase

Phase 1

Conditions

Opioid Use Disorder
Cocaine Use Disorder

Interventions

Oxytocin
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Jan 3, 2014

First Submission Date that Met QC Criteria

Jan 3, 2014

First Posted Date

Jan 7, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2019

Last Update Posted Date

May 21, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients 1	Active Comparator	Participants will receive intranasal oxytocin 40 International Units (IU).	Drug: Oxytocin
Patients 2	Placebo Comparator	Participants will receive 40 International Units of intranasal placebo.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxytocin	Drug		Patients 1	oxytocin nasal spray, Syntocinon
Placebo

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher S Stauffer, MD	University of California, San Francisco	Principal Investigator
Joshua Woolley, MD, PhD	University of California, San Francisco	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San Francisco General Hospital Opiate Treatment Outpatient Program		San Francisco	California	94110	United States

Condition Browse Module

MeSH Terms

ID	Term
D009293	Opioid-Related Disorders
D016739	Behavior, Addictive

Ancestor Terms

ID	Term
D000079524	Narcotic-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010121	Oxytocin

Ancestor Terms

ID	Term
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided