Oxytocin on Approach Bias and Craving

NCT03865615 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: Oxytocin Approach
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Oxytocin First

EXPERIMENTAL

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

Drug: Oxytocin; Drug: Placebo

Placebo First

EXPERIMENTAL

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

Drug: Oxytocin; Drug: Placebo

Interventions

Oxytocin DRUG

intranasal oxytocin 40IU/mL

Also known as: Syntocinon

Oxytocin First; Placebo First

Placebo DRUG

Placebo

Oxytocin First; Placebo First

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jennifer Mitchell: lead

Study Sites (1)

University of California, San Francisco

Berkeley, California, 94720, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jennifer Mitchell, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Within-subject, randomized, placebo-controlled, counterbalanced, crossover design.

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: March 7, 2019
• Study Start: November 1, 2023
• Primary Completion: April 20, 2024
• Study Completion: April 20, 2024
• Last Updated: June 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)