Oxytocin on Approach Bias and Craving

Study Overview
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Brief Summary
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This will be a laboratory-based investigation of the behavioral and neural effects of intranasal oxytocin on craving for alcohol and approach bias in moderate to heavy alcohol using subjects. This study uses a within-subject, randomized, placebo-controlled, counterbalanced, crossover design to compare the effects oxytocin and placebo. In this way, all subjects will be scanned twice; once following oxytocin administration and once following placebo administration, and will complete a series of behavioral tasks (both in and out of the scanner) at both visits.

Official Title
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The Effects of Intranasal Oxytocin on Approach Bias and Craving in Moderate to Heavy Alcohol Drinkers

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers who are 21-40 years of age If female, 10 or more alcoholic drinks must be consumed weekly. If male, 14 or more alcoholic drinks must be consumed weekly. Meets DSM-V criteria for Alcohol Use Disorder (AUD). Score 8 or greater on the Alcohol Use Disorders Identification Test (AUDIT) If female, must be non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device [IUD], hormonal birth control, or barrier method). Native English speaker Right handed High school graduate or equivalent. Able and willing to provide an informed consent. Able to understand and follow the instructions of the investigator Exclusion Criteria: Positive urine drug screen (except marijuana). Using cocaine, stimulants (other than nicotine and caffeine), amphetamines, hallucinogens, ecstasy, opiates, sedatives, pain pills, sleeping pills, or other psychoactive drugs within 2 weeks of the start of the study (except marijuana). Marijuana use more than 3 times/week. Current enrollment in an alcohol, or other drug treatment program or current legal problems relating to alcohol, or other drug use. Currently trying to quit alcohol use. History of major alcohol related complications within the preceding 2 years (liver failure/cirrhosis, pancreatitis, esophageal varices, etc.). Has a history of atrophic rhinitis, recurrent nose bleeds, cranial surgical procedures, hypophysectomy, chronic congestion, or sinus problems. Has a history of cardiac arrhythmia. Clinically significant medical or psychiatric illness requiring treatment as determined by screening blood tests, medical history, and/or physical exam performed or reviewed by the study physician. Severely low blood (< 90/50) pressure or uncontrolled high blood pressure (>160/100). SGPT/ALT or SGOT/AST values greater than 2x upper limit of normal. BAC level > 0.00% at the beginning of screening visit (within margin of error of detection). Has a neurological dysfunction or psychiatric disorder (confirm with study physician). Has a history of brain trauma (confirm with study physician). Has an allergy or intolerance to oxytocin. Has received an investigational drug within 30 days of Screening Visit. Has any MRI scanning contraindications. Has a history of claustrophobia.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Interventional Model Description: Within-subject, randomized, placebo-controlled, counterbalanced, crossover design.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin First<br>Subjects will receive oxytocin prior to their first scanning session, and placebo prior to their second scanning session. | Drug: Oxytocin<br>* intranasal oxytocin 40IU/mL<br>* Other names: Syntocinon;Drug: Placebo<br>* Placebo<br>|
| Experimental: Placebo First<br>Subjects will receive placebo prior to their first scanning session, and oxytocin prior to their second scanning session. | Drug: Oxytocin<br>* intranasal oxytocin 40IU/mL<br>* Other names: Syntocinon;Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol cue craving score | Subjects will be asked to perform a standardized alcohol cue exposure paradigm and be asked to rate their subjective craving following alcohol cue presentation using a standard visual analog scale. Craving scores (ranging from 1-10 on VAS) will be compared across both the active study drug and placebo. |   90 minutes post study drug administration | 
| Image approach task | Subjects will be asked to perform an image approach task where subjects are presented with a series of images and asked to pull or push a joystick following each presentation. Response direction and speed are recorded and compared across both the active study drug and placebo. |   90 minutes post study drug administration |