Methadone Oxytocin Option

Study Overview
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Brief Summary
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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.

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

Conditions
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Substance Abuse, Opioid Dependence, Methadone Treatment

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Saline Nasal Spray


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin<br>40 IU Oxytocin | Drug: Oxytocin<br>* 40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.<br>* Other names: Syntocinon;|
| Placebo Comparator: Saline Nasal Spray<br>Placebo Comparator | Drug: Saline Nasal Spray<br>* 40 IU of the saline nasal spray will be administered once at the beginning of the visit.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craving Questionnaires | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxytocin, Syntocinon, Social Cognition, Social Approach Behaviors