Intranasal Oxytocin and Social Cognition, Implicit Preferences and Craving in Alcohol Drinkers

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, placebo controlled, double blind crossover study of the effects of intranasal oxytocin on social cognition, implicit preferences and craving in moderate to heavy social alcohol drinkers.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

• Subject is a volunteer between 18 and 50 years of age.

• If female, subject is non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device [IUD], hormonal birth control, or barrier method).

• Subject is able to read and speak English.

• Subject is able and willing to provide written informed consent.

• Subject is able to understand and follow the instructions of the investigator and understand all screening questionnaires.

• Subject is in good health.

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) OR more than 10 times in the last year (except marijuana).

• Marijuana use more than 3 times/week.

• Has a current dependence on, or addiction to any psychoactive drug (except nicotine or caffeine) including alcohol OR a recent history of substance abuse other than alcohol, tobacco or marijuana.

• 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.

• BAC level > 0.05% 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.

• Subject has received an investigational drug within 30 days of Screening Visit.

• Subject is considered unsuitable for the study in the opinion of the investigator, nurse practitioner, or study physician for any other reason.