Oxytocin on Approach Bias and Craving

Phase 2

Withdrawn

• Conditions: Alcohol Use Disorder
• Interventions: Drug: Oxytocin; Drug: Placebo

• Registration Number: NCT03865615
• Lead Sponsor: Jennifer Mitchell

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-21
• Study First Submitted QC: 2019-03-05
• Study First Posted: 2019-03-07
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-01
• Last Update Posted: 2022-06-06
• Study Start: 2023-11-01
• Primary Completion: 2024-04-20
• Study Completion: 2024-04-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oxytocin First	Placebo	Subjects will receive oxytocin prior to their first scanning session, and placebo prior to their second scanning session.
Placebo First	Placebo	Subjects will receive placebo prior to their first scanning session, and oxytocin prior to their second scanning session.
Oxytocin First	Oxytocin	Subjects will receive oxytocin prior to their first scanning session, and placebo prior to their second scanning session.
Placebo First	Oxytocin	Subjects will receive placebo prior to their first scanning session, and oxytocin prior to their second scanning session.

Primary Outcome Measures

Name	Time	Method
Alcohol cue craving score	~ 90 minutes post study drug administration	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.
Image approach task	~ 90 minutes post study drug administration	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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 Berkeley, California, United States