Status:
WITHDRAWN
Oxytocin on Approach Bias and Craving
Lead Sponsor:
Jennifer Mitchell
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
21-40 years
Phase:
PHASE2
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 stu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03865615
Start Date
November 1 2023
End Date
April 20 2024
Last Update
June 6 2022
Active Locations (1)
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1
University of California, San Francisco
Berkeley, California, United States, 94720