Oxytocin on Approach Bias and Craving

NCT ID: NCT03865615

Last Updated: 2022-06-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-04-20

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.

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Oxytocin First

Subjects will receive oxytocin prior to their first scanning session, and placebo prior to their second scanning session.

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

intranasal oxytocin 40IU/mL

Placebo

Intervention Type: DRUG

Placebo

Placebo First

Subjects will receive placebo prior to their first scanning session, and oxytocin prior to their second scanning session.

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

intranasal oxytocin 40IU/mL

Placebo

Intervention Type: DRUG

Placebo

Interventions

Oxytocin

intranasal oxytocin 40IU/mL

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

Syntocinon

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jennifer Mitchell

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Mitchell

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jennifer Mitchell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

Berkeley, California, United States

Countries

United States

Other Identifiers

Oxytocin Approach

Identifier Type: -

Identifier Source: org_study_id