Status:
COMPLETED
Intranasal Oxytocin and Social Cognition, Implicit Preferences and Craving in Alcohol Drinkers
Lead Sponsor:
University of California, San Francisco
Conditions:
AOD Use, Abuse, and Dependence
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief 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 d...
Detailed Description
Impaired social functioning is an important feature of substance use disorders. Social deficits are a risk factor for developing substance use disorders as well as a consequence of substance abuse. Im...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01829516
Start Date
May 1 2013
End Date
November 1 2014
Last Update
July 27 2016
Active Locations (1)
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1
Ernest Gallo Clinic and Research Center
Emeryville, California, United States, 94608