Overview

This trial is active, not recruiting.

Condition aod use, abuse, and dependence
Treatments oxytocin, placebo
Phase phase 4
Sponsor University of California, San Francisco
Start date May 2013
End date May 2014
Trial size 50 participants
Trial identifier NCT01829516, Oxytocin

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal oxytocin.
oxytocin Syntocinon
(Placebo Comparator)
50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal placebo. NOTE: This is a cross-over design and subjects will participate in both arms.
placebo Placebo

Primary Outcomes

Measure
Average scores on The Awareness of Social Inference Test (TASIT), measure of social cognition, after administration of oxytocin vs. placebo during the 3-week study.
time frame: 3 weeks

Secondary Outcomes

Measure
Average scores on the Alcohol Approach Avoidance Task after administration of oxytocin vs. placebo during the 3-week study.
time frame: 3 weeks

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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.

Additional Information

Official title The Effects of Intranasal Oxytocin on Social Cognition, Implicit Preferences and Craving in Moderate to Heavy Social Alcohol Drinkers
Principal investigator Howard Fields, MD, PhD
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. Improved social functioning is also a key goal of effective substance abuse treatments. While treatment of disrupted social networks is a mainstay of psychosocial substance abuse treatments, there are currently no pharmacological interventions aimed at improving social functioning in individuals with substance use disorders. Oxytocin administration may shift preference from substance related cues to social cues and may decrease subjective craving for alcohol. The specific aims are: 1. To examine the effects of intranasal oxytocin administration on social cognition in moderate to heavy social alcohol drinkers. 2. To examine the effects of intranasal oxytocin administration on alcohol craving. 3. To examine the effects of intranasal oxytocin administration on implicit preferences for drug-related and social stimuli in moderate to heavy social alcohol drinkers.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by University of California, San Francisco.