The Effects of Intranasal Oxytocin on Social Cognition, Implicit Preferences and Craving in Moderate to Heavy Social Alcohol Drinkers

AOD Use, Abuse, and Dependence Clinical Trial

Official title:

The Effects of Intranasal Oxytocin on Social Cognition, Implicit Preferences and Craving in Moderate to Heavy Social Alcohol Drinkers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01829516
• Other study ID #: Oxytocin
• Status: Active, not recruiting
• Phase: Phase 4
• First received: April 9, 2013
• Last updated: January 17, 2014
• Start date: May 2013
• Est. completion date: November 2014

Study information

• Verified date: January 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: November 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• AOD Use, Abuse, and Dependence

Intervention

Drug:
• Oxytocin

• Placebo

Locations

Country	Name	City	State
United States	Ernest Gallo Clinic and Research Center	Emeryville	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	We will examine the effects of intranasal oxytocin administration in moderate to heavy social alcohol drinkers on average social cognition scores using a validated measure of social cognition (TASIT) before and after administration of oxytocin.	3 weeks	No
Secondary	Average scores on the Alcohol Approach Avoidance Task after administration of oxytocin vs. placebo during the 3-week study.	We will examine the effects of intranasal oxytocin administration on implicit preferences for drug-related and social stimuli in moderate to heavy social alcohol drinkers before and after oxytocin administration.	3 weeks	No