Oxytocin on Approach Bias and Craving

• Status: Not yet recruiting
• Trial end date: 2023-04-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jennifer Mitchell; University of California, San Francisco
• Treatments: Oxytocin

Criteria

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.