Methadone Oxytocin Option (MOO)

This study has been completed.
Sponsor:
Collaborator:
San Francisco Veterans Administration Medical Center
Information provided by (Responsible Party):
Joshua Woolley, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01728909
First received: November 7, 2012
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Substance Abuse
Opioid Dependence
Methadone Treatment
Drug: Oxytocin
Drug: Saline Nasal Spray
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Intranasal Oxytocin on Social Cognition and Social Approach Behaviors in Opioid-dependent Patients Receiving Methadone Treatment

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Computerized Social Cognition Tasks [ Time Frame: Participants will complete 2 days of the study. These 2 days will be at least a week apart. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Craving Questionnaires [ Time Frame: Participants will complete 2 days of the study. These 2 days will be at least a week apart. ] [ Designated as safety issue: No ]
    Participants are asked to rate their current symptoms and current craving levels and for different substances.


Enrollment: 64
Study Start Date: May 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Syntocinon
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 Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01728909

Locations
United States, California
San Francisco VA Medical Center
San Francisco, California, United States, 94121
Sponsors and Collaborators
University of California, San Francisco
San Francisco Veterans Administration Medical Center
Investigators
Principal Investigator: Joshua Woolley, MD, PhD University of California San Francisco, San Francisco Veterans Affairs Medical Center
  More Information

No publications provided

Responsible Party: Joshua Woolley, Assistant Professor in Residence, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01728909     History of Changes
Other Study ID Numbers: 0
Study First Received: November 7, 2012
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
Oxytocin
Syntocinon
Social Cognition
Social Approach Behaviors

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014