Clinical trial NCT01829516: Intranasal Oxytocin and Social Cognition, Implicit Preferences and Craving in Alcohol Drinkers
Official title: The Effects of Intranasal Oxytocin on Social Cognition, Implicit Preferences and Craving in Moderate to Heavy Social Alcohol Drinkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: AOD Use, Abuse, and Dependence
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2013-04-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 drinkers.

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. 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.

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.

Primary outcomes:
measure: Change in Craving on the Alcohol Urge Questionnaire (AUQ) After Administration of Oxytocin vs. Placebo During the 3-week Study.
timeFrame: Measured just prior to and after each of the water and alcohol cues at visits 2 and 3.
Secondary outcomes:
measure: 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.
timeFrame: Administered at visits 2 and 3
Other outcomes:
Locations:
city: Emeryville
country: United States
facility: Ernest Gallo Clinic and Research Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Josh Woolley, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: