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Completed

NCT Number: NCT01728909

Methadone Oxytocin Option

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.

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Key information

Conditions

Substance Abuse Chemically-Induced Disorders Mental Disorders Methadone Treatment Narcotic-Related Disorders Opioid Dependence Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin

Drug

40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.

Other names: Syntocinon

Saline Nasal Spray

Drug

40 IU of the saline nasal spray will be administered once at the beginning of the visit.

Other names: Placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • San Francisco Veterans Affairs Medical Center

Registry information

Official study title

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

Acronym: MOO

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 20, 2012
Registry last updated
May 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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