Methadone Oxytocin Option (MOO)

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

The Effects of Intranasal Oxytocin on Social Cognition and Social Approach Behaviors in Opioid-dependent Patients

The purpose of the study is to examine the effects of intranasal oxytocin administration on social cognition in patients receiving methadone maintenance treatment (MMT), examine the effects of intranasal oxytocin administration on opioid craving and on the subjective effects of methadone, and examine the effects of intranasal oxytocin administration on implicit preferences for drug-related and social stimuli in patients receiving MMT.

Hypothesis 1: Patients will perform better on measures of social cognition (including affect recognition and recognition of sarcasm) after administration of oxytocin compared with placebo.

Hypothesis 2: Patients will demonstrate lower craving for opioids and greater subjective effects of methadone after administration of oxytocin compared with placebo.

Hypothesis 3: Patients will demonstrate increased implicit preferences for social stimuli and decreased implicit preferences for drug related stimuli after administration of oxytocin compared with placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Early 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, 94121
        • San Francisco VA Medical Center

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

Male

Description

Inclusion Criteria for patients:

  • Primary diagnosis of opioid dependence according to DSM-IV TR
  • Opioid of choice be either heroin or oral opioid analgesics
  • Currently be on stable dose of methadone with no dose change in the last 14 days

Inclusion Criteria for healthy volunteers

-No diagnosis of mental disorder according to DSM-IV TR

Exclusion Criteria for patients and healthy volunteers:

  • Epilepsy
  • Current illicit drug use (within the past one month)
  • Current sever depression with suicidal thoughts and/or actions
  • Addiction to alcohol or drugs other than opiates, caffeine, or nicotine
  • Psychotic illness
  • Bipolar disorder
  • Brain trauma
  • Severe Neuropsychological disorder
  • Kidney Disease (i.e., kidney stones, recurrent bladder infections, or known kidney failure)
  • Sensitivity to preservatives (in particular E216, E218, and chlorobutanol hemihydrate)
  • Nasal obstruction, discharge, or bleeding
  • Cardiovascular problems (e.g., heart disease, history of heart attacks), high blood pressure (hypertension)
  • Habitually drink large volumes of water

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Saline Nasal Spray
Placebo Comparator
Drug: Saline Nasal Spray
40 IU of the saline nasal spray will be administered once at the beginning of the visit.
Other Names:
  • Placebo
Experimental: Oxytocin
40 IU Oxytocin
Drug: Oxytocin
40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
Other Names:
  • Syntocinon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Computerized Social Cognition Tasks
Time Frame: Participants will complete 2 days of the study. These 2 days will be at least a week apart.
Participants will undergo computer tasks that measure social cognition, which include the TASIT, RMET, and the IAT. The TASIT measures the awareness of social inference, the RMET measures the ability to guess the emotions of others, and the IAT measures implicit associations.
Participants will complete 2 days of the study. These 2 days will be at least a week apart.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Craving Questionnaires
Time Frame: Participants will complete 2 days of the study. These 2 days will be at least a week apart.
Participants are asked to rate their current symptoms and current craving levels and for different substances.
Participants will complete 2 days of the study. These 2 days will be at least a week apart.

Collaborators and Investigators

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

Sponsor

University of California, San Francisco

Collaborators

San Francisco Veterans Affairs Medical Center

Investigators

  • Principal Investigator: Joshua Woolley, MD, PhD, University of California San Francisco, San Francisco Veterans Affairs Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

November 7, 2012

First Submitted That Met QC Criteria

November 13, 2012

First Posted (Estimate)

November 20, 2012

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

  • 11-07691

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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