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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Jennifer Mitchell, University of California, San Francisco

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.

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

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




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.



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829516


Locations
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United States, California
Ernest Gallo Clinic and Research Center
Emeryville, California, United States, 94608
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Josh Woolley, MD, PhD University of California, San Francisco
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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    Key Record Dates
Results First Posted: June 27, 2016
Last Update Posted: July 27, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs