Phase 4 N=32 Randomized Double-blind Treatment

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

AOD Use, Abuse, and Dependence

Bottom Line

View on ClinicalTrials.gov: NCT01829516 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2016

Primary outcome: Primary: Change in Craving on the Alcohol Urge Questionnaire (AUQ) After Administration of Oxytocin vs. Placebo During the 3-week Study. — 1.11; 0.69 units on a 7-pt Likert Scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Oxytocin (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of California, San Francisco
Primary completion: May 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Craving on the Alcohol Urge Questionnaire (AUQ) After Administration of Oxytocin vs. Placebo During the 3-week Study.	1.11; 0.69	—
SECONDARY Average Percentage of Correct Responses on a Social Perception Task, Reading the Mind in the Eyes Test (RMET) After Administration of Oxytocin vs. Placebo During the 3-week Study.	77.2; 76.4	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01829516). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.