Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Oxytocin

+ Placebo

Drug
Who is being recruted

From 18 to 50 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: May 2013
See protocol details

Summary

Principal SponsorUniversity of California, San Francisco
Last updated: July 27, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2013

Actual date on which the first participant was enrolled.

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: To examine the effects of intranasal oxytocin administration on social cognition in moderate to heavy social alcohol drinkers. To examine the effects of intranasal oxytocin administration on alcohol craving. To examine the effects of intranasal oxytocin administration on implicit preferences for drug-related and social stimuli in moderate to heavy social alcohol drinkers.

NCT01829516
Principal SponsorUniversity of California, San Francisco
Last updated: July 27, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

32 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

6 inclusion criteria required to participate
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 a volunteer between 18 and 50 years of age
Subject is able and willing to provide written informed consent
Subject is able to read and speak English
Show More Criteria
11 exclusion criteria prevent from participating
BAC level > 0.05% at the beginning of screening visit (within margin of error of detection)
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
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
Has a history of brain trauma (confirm with study physician)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal oxytocin.

Group II

Placebo
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Ernest Gallo Clinic and Research Center

Emeryville, United StatesOpen Ernest Gallo Clinic and Research Center in Google Maps
CompletedOne Study Center