Summary

Eligibility
for people ages 21-40 (full criteria)
Location
at Berkeley, California
Dates
study started
estimated completion
Principal Investigator
by Jennifer Mitchell, PhD
Photo of Jennifer Mitchell
Jennifer Mitchell

Description

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.

Official Title

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

Keywords

Alcohol Use Disorder Alcoholism Oxytocin Oxytocin First

Eligibility

You can join if…

Open to people ages 21-40

  • 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 CAN'T join 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.
  • Has received an investigational drug within 30 days of Screening Visit.
  • Has any MRI scanning contraindications.
  • Has a history of claustrophobia.

Location

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

Lead Scientist at UCSF

  • Jennifer Mitchell, PhD
    Jennifer Mitchell is a Professor in the Departments of Neurology and Psychiatry and the Deputy Associate Chief of Staff for Research and Development at the San Francisco VA. She received her PhD in Neuroscience from UCSF, where her doctoral research focused on understanding how stress and anxiety influence opioid tolerance and addiction.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Jennifer Mitchell
ID
NCT03865615
Phase
Phase 2
Study Type
Interventional
Last Updated