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
|Condition or disease||Intervention/treatment||Phase|
|AOD Use, Abuse, and Dependence||Drug: Oxytocin Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
50 moderate to heavy social alcohol users will receive a single dose 40 IU of 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829516
|United States, California|
|Ernest Gallo Clinic and Research Center|
|Emeryville, California, United States, 94608|
|Principal Investigator:||Josh Woolley, MD, PhD||University of California, San Francisco|