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

• ClinicalTrials.gov Identifier: NCT01829516
• Recruitment Status: Completed
• First Posted: April 11, 2013
• Results First Posted: June 27, 2016
• Last Update Posted: July 27, 2016
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): Jennifer Mitchell, University of California, San Francisco

Study Description

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.

Condition or disease	Intervention/treatment	Phase
AOD Use, Abuse, and Dependence	Drug: Oxytocin; Drug: Placebo	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Effects of Intranasal Oxytocin on Social Cognition, Implicit Preferences and Craving in Moderate to Heavy Social Alcohol Drinkers
• Study Start Date: May 2013
• Actual Primary Completion Date: May 2014
• Actual Study Completion Date: November 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Oxytocin; 50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal oxytocin.	Drug: Oxytocin; Intranasal oxytocin; Other Name: Syntocinon
Placebo Comparator: 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.	Drug: Placebo; Intranasal placebo

Outcome Measures

Primary Outcome Measures :

1. Change in Craving on the Alcohol Urge Questionnaire (AUQ) After Administration of Oxytocin vs. Placebo During the 3-week Study. [ Time Frame: Measured just prior to and after each of the water and alcohol cues at visits 2 and 3. ]
   Change in craving represented by the mean difference in Alcohol Urge Questionnaire (AUQ) craving scores between alcohol and water cues (e.g., a positive alcohol-water score indicates cue-induced craving) after administration of oxytocin vs. placebo during the 3-week study. Craving for alcohol was assessed prior to the water and alcohol cues and again after each stimulus presentation using the 8-item Alcohol Urge Questionnaire (AUQ) (Bohn et al., 1995), in which subjects indicate how much they agree or disagree with statements regarding their alcohol craving on a 7-point Likert scale. AUQ craving scores are calculated by averaging responses to the 8 items. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by averaging the item scores and ranges from 1 to 7. Higher scores reflect greater craving.

Secondary Outcome Measures :

1. 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. [ Time Frame: Administered at visits 2 and 3 ]
   We will examine the effects of intranasal oxytocin administration on overall RMET performance in moderate to heavy social alcohol drinkers after placebo or oxytocin administration. The RMET has 28 items. Each item is an cropped photo of a person's eyes with four emotion labels around it. The subjects are asked to select which one of the four emotion words best describes the emotion that the eyes are showing. RMET is scored by adding up the total number of correct responses (range 0-28). The mean percent correct is then calculated.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, California

Ernest Gallo Clinic and Research Center

Emeryville, California, United States, 94608

Sponsors and Collaborators

University of California, San Francisco

Investigators

• Principal Investigator: Josh Woolley, MD, PhD; University of California, San Francisco

More Information

• Responsible Party: Jennifer Mitchell, Principal Investigator, University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT01829516
• Other Study ID Numbers: Oxytocin
• First Posted: April 11, 2013
• Results First Posted: June 27, 2016
• Last Update Posted: July 27, 2016
• Last Verified: June 2016

Additional relevant MeSH terms:

Oxytocin; Oxytocics; Reproductive Control Agents; Physiological Effects of Drugs