Oxytocin on Approach Bias and Craving

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Drug: Placebo; Drug: Oxytocin

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94720
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jennifer Mitchell
• Investigators: Principal Investigator: Jennifer Mitchell, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2023
• Primary Completion (Anticipated): April 20, 2024
• Study Completion (Anticipated): April 20, 2024

Study Registration Dates

• First Submitted: December 21, 2018
• First Submitted That Met QC Criteria: March 5, 2019
• First Posted (Actual): March 7, 2019

Study Record Updates

• Last Update Posted (Actual): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: Oxytocin Approach

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No