Methadone Oxytocin Option
MOO
The Effects of Intranasal Oxytocin on Social Cognition and Social Approach Behaviors in Opioid-dependent Patients
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started May 2012
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 7, 2012
CompletedFirst Posted
Study publicly available on registry
November 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedMay 21, 2019
May 1, 2019
2.4 years
November 7, 2012
May 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Participants will complete 2 days of the study. These 2 days will be at least a week apart.
Secondary Outcomes (1)
Craving Questionnaires
Participants will complete 2 days of the study. These 2 days will be at least a week apart.
Study Arms (2)
Oxytocin
EXPERIMENTAL40 IU Oxytocin
Saline Nasal Spray
PLACEBO COMPARATORPlacebo Comparator
Interventions
40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
40 IU of the saline nasal spray will be administered once at the beginning of the visit.
Eligibility Criteria
You may qualify if:
- 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
- No diagnosis of mental disorder according to DSM-IV TR
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Francisco VA Medical Center
San Francisco, California, 94121, United States
Related Publications (1)
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.
PMID: 27137199DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joshua Woolley, MD, PhD
University of California San Francisco, San Francisco Veterans Affairs Medical Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor in Residence
Study Record Dates
First Submitted
November 7, 2012
First Posted
November 20, 2012
Study Start
May 1, 2012
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
May 21, 2019
Record last verified: 2019-05