Cocaine Opioid Oxytocin Option

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Opioid Use Disorder Cocaine Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Patients 1

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

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Patients 2

Participants will receive 40 International Units of intranasal placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Oxytocin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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oxytocin nasal spray, Syntocinon placebo nasal spray

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No