Back to resultsMethadone Oxytocin Option (MOO)
Primary Purpose
Substance Abuse, Opioid Dependence, Methadone Treatment
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Saline Nasal Spray
Sponsored by
About this trial
This is an interventional treatment trial for Substance Abuse focused on measuring Oxytocin, Syntocinon, Social Cognition, Social Approach Behaviors
Eligibility 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
Sites / Locations
- San Francisco VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Oxytocin
Saline Nasal Spray
Arm Description
40 IU Oxytocin
Placebo Comparator
Outcomes
Primary Outcome Measures
Computerized Social Cognition Tasks
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
Participants are asked to rate their current symptoms and current craving levels and for different substances.
Full Information
NCT ID
NCT01728909
First Posted
November 7, 2012
Last Updated
May 17, 2019
Sponsor
University of California, San Francisco
Collaborators
San Francisco Veterans Affairs Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01728909
Brief Title
Methadone Oxytocin Option
Acronym
MOO
Official Title
The Effects of Intranasal Oxytocin on Social Cognition and Social Approach Behaviors in Opioid-dependent Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco
Collaborators
San Francisco Veterans Affairs Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Opioid Dependence, Methadone Treatment
Keywords
Oxytocin, Syntocinon, Social Cognition, Social Approach Behaviors
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxytocin
Arm Type
Experimental
Arm Description
40 IU Oxytocin
Arm Title
Saline Nasal Spray
Arm Type
Placebo Comparator
Arm Description
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Syntocinon
Intervention Description
40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
Intervention Type
Drug
Intervention Name(s)
Saline Nasal Spray
Other Intervention Name(s)
Placebo
Intervention Description
40 IU of the saline nasal spray will be administered once at the beginning of the visit.
Primary Outcome Measure Information:
Title
Computerized Social Cognition Tasks
Description
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.
Time Frame
Participants will complete 2 days of the study. These 2 days will be at least a week apart.
Secondary Outcome Measure Information:
Title
Craving Questionnaires
Description
Participants are asked to rate their current symptoms and current craving levels and for different substances.
Time Frame
Participants will complete 2 days of the study. These 2 days will be at least a week apart.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Woolley, MD, PhD
Organizational Affiliation
University of California San Francisco, San Francisco Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco VA Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27137199
Citation
Woolley JD, Arcuni PA, Stauffer CS, Fulford D, Carson DS, Batki S, Vinogradov S. The effects of intranasal oxytocin in opioid-dependent individuals and healthy control subjects: a pilot study. Psychopharmacology (Berl). 2016 Jul;233(13):2571-80. doi: 10.1007/s00213-016-4308-8. Epub 2016 May 3.
Results Reference
derived
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Methadone Oxytocin Option
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