Social Perception
Conditions
Keywords
Intranasal oxytocin, Social perception, EEG/ERP
Brief summary
The objective of this study is to investigate the effects of oxytocin on social behavior and brain activity using EEG and the event-related potential (ERP) technique. The value of EEG is its high temporal specificity, enabling precision in the timing of social behavior to be addressed. In order to elicit social responses in the human brain, a variety of social and emotional visual stimuli will be presented during EEG recording, namely infant and adult faces and houses. Brain responses after intranasal oxytocin will then be compared with placebo, to examine the effect of intranasal oxytocin on central nervous system activity. We hypothesize that intranasal oxytocin will enhance the neural response to social stimuli (infant and adult faces) but not to non-social stimuli (houses).
Interventions
DRUGOxytocin
24 International Units of Oxytocin in a Nasal Spray
OTHERPlacebo
Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.
Sponsors
Anna Freud
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults ages 18-64 * Good medical health * Ability to understand and speak English
Exclusion criteria
* Pregnancy * Medical Illnesses: Moderate or severe acute or chronic medical illnesses (e.g. cardiac disease, diabetes, epilepsy, influenza). * Cardiovascular risk factors: History of hypertension with baseline blood pressure above 140 mm Hg (systolic) over 90 mm Hg (diastolic). Also any history of syncope and/or baseline blood pressure below 100 mm Hg (systolic). * CNS disease: Known history of brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), other central nervous system disease, or history of head trauma which resulted in a persistent neurologic deficit or loss of consciousness \> 3 minutes. * Medication status: Individuals on stable doses of a neuroleptic and/or an antidepressant medication for at least the past 6 weeks will be allowed to participate in this study. The use of other psychotropic medications will not be allowed. Females taking contraceptive hormones will not be able to participate in the study. * A history of seizures or current use of anticonvulsants; history of head injury with loss of consciousness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amplitude Social | Duration of 30 minutes | The investigators will analyze the amplitude (i.e., size) of visually elicited event-related potential (ERP) components to the social stimuli (infant and adult faces). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that the intervention will modulate the amplitude of the neural response to social stimuli given its previously identified role in social interactions, most likely increasing the size of the ERPs. |
| Amplitude Non-Social | Duration of 30 minutes | The investigators analyze the amplitude (i.e., size) of visually elicited event-related potential (ERP) components to the non-social stimuli (houses). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be no difference between the intervention and placebo during the non-social condition on the amplitude of the ERPs. |
| Latency Social | Duration of 30 minutes | The investigators analyze the latency (i.e., efficiency of processing) of visually elicited ERP components to the social stimuli (infant and adult faces). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be more efficient processing (i.e., earlier latency) of ERPs during the social condition following administration of the intervention relative to the placebo condition. |
| Latency Non-Social | Duration of 30 minutes | The investigators will analyze the latency (i.e., efficiency of processing) of visually elicited ERP components to the non-social stimuli (houses). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be no difference between the intervention and placebo on ERP latency measures in the non-social condition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early Experience | Within 20 minutes of study visit commencing | The investigators will employ the Parental Bonding Instrument (Parker, Tupling, & Brown, 1979) to assess the early relationship experiences participants have with their caregivers. Existing research employing intranasal oxytocin suggests that the quality of early relationships may impact the strength of any modulation of brain or behavior by oxytocin administration and therefore this variable will be included in the analyses in support of this hypothesis. There are 12 items that capture parental care and 13 items that capture parental overprotection. Items are scored on a 4-point likert scale from very like to very unlike. The PBI is typically scored by identifying optimal (High Care Scores, Low Protection Scores) and less optimal (Low Care Scores, Low Protection Scores) scores on the mother and father subscales (NB: protection refers to overprotection). For the care items, scores can range from 0 to 36; for overprotection items, scores can range from 0 to 39. |
| Depression | Within 20 minutes of study visit commencing | The investigators will assess depression by employing the Beck Depression Inventory (Beck et al., 1961). Specifically addressing whether the level of depression symptomatology in participants and whether this is associated with the neural correlates of social and non-social perception during both intervention and placebo visits. It is not yet known the extent to which variation in depression symptoms are associated with this methodology, although prior research has suggested depression modulates the neural response to social cues. This measure includes a question regarding suicidal ideation and therefore it is acknowledged there may be a safety issue in response to the questionnaire. Scores range from 0-63, with higher scores indicating greater levels of depression (scores 29+ indicates severe depression). |
| Number of Participants Testing Positive for Alcohol Use Following a Breathalyzer | Within 30 minutes of study visit commencing | Participants will complete an alcohol breathalyzer to characterize the alcohol use status of the sample. |
| Number of Participants Endorsing Substance Use | Within 30 minutes of study visit commencing | The investigators will employ the ASI Lite (McLellan, Luborsky, Woody, & O'Brien, 1980) to assess for current substance use. This measure is included to characterize the sample in respect of substance use; however the ASI Lite did not provide a measure of substance dependance and therefore we report the data from the Mini International Neuropsychiatric Interview substance dependance module (Sheehan et al., 1998) to provide a specific indication of the presence of absence of substance dependance. |
| Smoking | Within 30 minutes of study visit commencing | Participants will complete a CO breathalyzer and the Fagerstrom Test for Nicotine Dependence (Heatherton, Kozlowski, Frecker, & Fagerstrom, 1991) to assess smoking behavior. These measures are included to characterize the sample in respect of substance use. |
| Anxiety | Within 20 minutes of study visit commencing | The investigators will assess anxiety using the State-Trait Anxiety Inventory (Spielberger et al., 1970). Specifically, it will be explored whether participant anxiety symptoms are associated with the neural correlates of social and non-social perception during both intervention and placebo visits. It is not yet known the extent to which variation in anxiety symptoms are associated with this methodology, although prior research has suggested anxiety modulates the neural response to social cues. Scores range from 20-80 and a higher score on both state and trait measures indicate higher levels of anxiety. A potential clinical cut off has been proposed for participants scoring over 39-40 as being high anxious. |
| Stress | Within 20 minutes of study visit commencing | The investigators will measure current levels of stress by using the Perceived Stress Scale (Cohen et al., 1983). It is not yet known the extent to which variation in perceived stress is associated with this methodology, but it is anticipated stress will be associated with levels of depression and anxiety in the sample. The PSS consists of 14 items, with scores ranging from 0 to 42, with higher scores indicating higher levels of perceived stress. A score of 21+ is considered to indicate that participants have higher than average stress. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxytocin Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray | 12 |
| Placebo Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray. | 14 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Oxytocin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 12 Participants | 26 Participants |
| Age, Continuous | 23 years STANDARD_DEVIATION 3 | 24 years STANDARD_DEVIATION 3 | 24 years STANDARD_DEVIATION 3 |
| Region of Enrollment United States | 14 participants | 12 participants | 26 participants |
| Sex: Female, Male Female | 14 Participants | 12 Participants | 26 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 26 | 0 / 25 |
| serious Total, serious adverse events | 0 / 26 | 0 / 25 |
Outcome results
Primary
Amplitude Non-Social
The investigators analyze the amplitude (i.e., size) of visually elicited event-related potential (ERP) components to the non-social stimuli (houses). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be no difference between the intervention and placebo during the non-social condition on the amplitude of the ERPs.
Time frame: Duration of 30 minutes
Population: 1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxytocin | Amplitude Non-Social | N170 House | -1.15 microvolts | Standard Deviation 1.71 |
| Oxytocin | Amplitude Non-Social | P300 House | 1.21 microvolts | Standard Deviation 1.47 |
| Oxytocin | Amplitude Non-Social | LPP House | -0.58 microvolts | Standard Deviation 1.12 |
| Placebo | Amplitude Non-Social | N170 House | -1.15 microvolts | Standard Deviation 1.35 |
| Placebo | Amplitude Non-Social | P300 House | 0.86 microvolts | Standard Deviation 0.91 |
| Placebo | Amplitude Non-Social | LPP House | -0.32 microvolts | Standard Deviation 1.06 |
Comparison: N170 Analysisp-value: >0.14ANOVA
Comparison: P300 Analysisp-value: >0.17t-test, 2 sided
Comparison: LPP Analysisp-value: >0.27t-test, 2 sided
Primary
Amplitude Social
The investigators will analyze the amplitude (i.e., size) of visually elicited event-related potential (ERP) components to the social stimuli (infant and adult faces). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that the intervention will modulate the amplitude of the neural response to social stimuli given its previously identified role in social interactions, most likely increasing the size of the ERPs.
Time frame: Duration of 30 minutes
Population: 1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms); for LPP analysis, 1 participant was a statistical outlier and removed from oxytocin and placebo arms
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxytocin | Amplitude Social | N170 Infant Distress Faces | -3.72 microvolts | Standard Deviation 2.81 |
| Oxytocin | Amplitude Social | P300 Infant Distress Face | 0.94 microvolts | Standard Deviation 1.26 |
| Oxytocin | Amplitude Social | P300 Adult Distress Face | 0.65 microvolts | Standard Deviation 1.22 |
| Oxytocin | Amplitude Social | P300 Infant Neutral Face | 1.10 microvolts | Standard Deviation 1.47 |
| Oxytocin | Amplitude Social | N170 Infant Neutral | -3.28 microvolts | Standard Deviation 2.55 |
| Oxytocin | Amplitude Social | LPP Infant Distress Face | -0.56 microvolts | Standard Deviation 1.53 |
| Oxytocin | Amplitude Social | LPP Infant Neutral Face | -0.24 microvolts | Standard Deviation 1.4 |
| Oxytocin | Amplitude Social | N170 Adult Distress | -3.70 microvolts | Standard Deviation 2.72 |
| Oxytocin | Amplitude Social | LPP Adult Distress Face | -0.38 microvolts | Standard Deviation 1.33 |
| Oxytocin | Amplitude Social | P300 Adult Neutral Face | 0.52 microvolts | Standard Deviation 1.38 |
| Oxytocin | Amplitude Social | LPP Adult Neutral Face | -0.71 microvolts | Standard Deviation 1.49 |
| Oxytocin | Amplitude Social | N170 Adult Neutral | -3.23 microvolts | Standard Deviation 2.48 |
| Placebo | Amplitude Social | LPP Adult Neutral Face | -0.40 microvolts | Standard Deviation 1.27 |
| Placebo | Amplitude Social | P300 Adult Distress Face | 0.39 microvolts | Standard Deviation 0.91 |
| Placebo | Amplitude Social | N170 Infant Distress Faces | -3.55 microvolts | Standard Deviation 2.64 |
| Placebo | Amplitude Social | N170 Infant Neutral | -3.30 microvolts | Standard Deviation 2.94 |
| Placebo | Amplitude Social | N170 Adult Distress | -3.27 microvolts | Standard Deviation 2.64 |
| Placebo | Amplitude Social | N170 Adult Neutral | -2.87 microvolts | Standard Deviation 2.33 |
| Placebo | Amplitude Social | P300 Infant Distress Face | 0.50 microvolts | Standard Deviation 1.21 |
| Placebo | Amplitude Social | P300 Infant Neutral Face | 0.55 microvolts | Standard Deviation 1.34 |
| Placebo | Amplitude Social | LPP Infant Distress Face | -0.50 microvolts | Standard Deviation 0.94 |
| Placebo | Amplitude Social | LPP Infant Neutral Face | -0.54 microvolts | Standard Deviation 1.51 |
| Placebo | Amplitude Social | LPP Adult Distress Face | -0.57 microvolts | Standard Deviation 1.4 |
| Placebo | Amplitude Social | P300 Adult Neutral Face | 0.61 microvolts | Standard Deviation 1.09 |
Comparison: N170 Analysisp-value: 0.003ANOVA
Comparison: N170 Analysisp-value: 0.034ANOVA
Comparison: P300 Analysisp-value: 0.03ANOVA
Comparison: P300 Analysisp-value: 0.03ANOVA
Comparison: LPP Analysisp-value: >0.22ANOVA
Primary
Latency Non-Social
The investigators will analyze the latency (i.e., efficiency of processing) of visually elicited ERP components to the non-social stimuli (houses). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be no difference between the intervention and placebo on ERP latency measures in the non-social condition.
Time frame: Duration of 30 minutes
Population: 1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms); 2 participants were statistical outliers and removed from oxytocin and placebo arms for N170 latency analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxytocin | Latency Non-Social | Left N170 House | 171 milliseconds | Standard Deviation 13 |
| Oxytocin | Latency Non-Social | Right N170 House | 166 milliseconds | Standard Deviation 9 |
| Placebo | Latency Non-Social | Left N170 House | 174 milliseconds | Standard Deviation 14 |
| Placebo | Latency Non-Social | Right N170 House | 169 milliseconds | Standard Deviation 13 |
Comparison: Only relevant for N170p-value: 0.03ANOVA
Comparison: Only relevant for N170p-value: 0.008ANOVA
Primary
Latency Social
The investigators analyze the latency (i.e., efficiency of processing) of visually elicited ERP components to the social stimuli (infant and adult faces). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be more efficient processing (i.e., earlier latency) of ERPs during the social condition following administration of the intervention relative to the placebo condition.
Time frame: Duration of 30 minutes
Population: 1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms); for LPP analysis, 1 participants were statistical outliers and removed from oxytocin and placebo arms for N170 latency analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxytocin | Latency Social | N170 Adult Distress | 164 milliseconds | Standard Deviation 10 |
| Oxytocin | Latency Social | N170 Adult Neutral | 161 milliseconds | Standard Deviation 9 |
| Oxytocin | Latency Social | N170 Infant Neutral | 163 milliseconds | Standard Deviation 9 |
| Oxytocin | Latency Social | N170 Infant Distress | 164 milliseconds | Standard Deviation 8 |
| Oxytocin | Latency Social | Left N170 Infant Distress | 165 milliseconds | Standard Deviation 9 |
| Oxytocin | Latency Social | Right N170 Infant Distress | 164 milliseconds | Standard Deviation 8 |
| Oxytocin | Latency Social | Left N170 Infant Neutral | 165 milliseconds | Standard Deviation 11 |
| Oxytocin | Latency Social | Right N170 Infant Neutral | 161 milliseconds | Standard Deviation 7 |
| Oxytocin | Latency Social | Left N170 Adult Distress | 166 milliseconds | Standard Deviation 11 |
| Oxytocin | Latency Social | Right N170 Adult Distress | 162 milliseconds | Standard Deviation 9 |
| Oxytocin | Latency Social | Left N170 Adult Neutral | 163 milliseconds | Standard Deviation 10 |
| Oxytocin | Latency Social | Right N170 Adult Neutral | 159 milliseconds | Standard Deviation 8 |
| Placebo | Latency Social | Left N170 Adult Neutral | 162 milliseconds | Standard Deviation 13 |
| Placebo | Latency Social | N170 Adult Distress | 163 milliseconds | Standard Deviation 12 |
| Placebo | Latency Social | Left N170 Infant Neutral | 163 milliseconds | Standard Deviation 10 |
| Placebo | Latency Social | N170 Adult Neutral | 161 milliseconds | Standard Deviation 11 |
| Placebo | Latency Social | Right N170 Adult Distress | 161 milliseconds | Standard Deviation 9 |
| Placebo | Latency Social | N170 Infant Neutral | 161 milliseconds | Standard Deviation 9 |
| Placebo | Latency Social | Right N170 Infant Neutral | 160 milliseconds | Standard Deviation 9 |
| Placebo | Latency Social | N170 Infant Distress | 164 milliseconds | Standard Deviation 10 |
| Placebo | Latency Social | Right N170 Adult Neutral | 160 milliseconds | Standard Deviation 10 |
| Placebo | Latency Social | Left N170 Infant Distress | 166 milliseconds | Standard Deviation 10 |
| Placebo | Latency Social | Left N170 Adult Distress | 165 milliseconds | Standard Deviation 14 |
| Placebo | Latency Social | Right N170 Infant Distress | 162 milliseconds | Standard Deviation 9 |
Comparison: Only relevant for N170p-value: 0.006ANOVA
Comparison: Only relevant for N170p-value: 0.01ANOVA
Secondary
Anxiety
The investigators will assess anxiety using the State-Trait Anxiety Inventory (Spielberger et al., 1970). Specifically, it will be explored whether participant anxiety symptoms are associated with the neural correlates of social and non-social perception during both intervention and placebo visits. It is not yet known the extent to which variation in anxiety symptoms are associated with this methodology, although prior research has suggested anxiety modulates the neural response to social cues. Scores range from 20-80 and a higher score on both state and trait measures indicate higher levels of anxiety. A potential clinical cut off has been proposed for participants scoring over 39-40 as being high anxious.
Time frame: Within 20 minutes of study visit commencing
Population: Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxytocin | Anxiety | State Anxiety | 31.54 units on a scale | Standard Deviation 10.67 |
| Oxytocin | Anxiety | Trait Anxiety | 30.58 units on a scale | Standard Deviation 10.11 |
| Placebo | Anxiety | State Anxiety | 35.50 units on a scale | Standard Deviation 11.27 |
| Placebo | Anxiety | Trait Anxiety | 30.79 units on a scale | Standard Deviation 7.82 |
p-value: 0.05correlation
Secondary
Depression
The investigators will assess depression by employing the Beck Depression Inventory (Beck et al., 1961). Specifically addressing whether the level of depression symptomatology in participants and whether this is associated with the neural correlates of social and non-social perception during both intervention and placebo visits. It is not yet known the extent to which variation in depression symptoms are associated with this methodology, although prior research has suggested depression modulates the neural response to social cues. This measure includes a question regarding suicidal ideation and therefore it is acknowledged there may be a safety issue in response to the questionnaire. Scores range from 0-63, with higher scores indicating greater levels of depression (scores 29+ indicates severe depression).
Time frame: Within 20 minutes of study visit commencing
Population: Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Depression | 4.00 units on a scale | Standard Deviation 6.06 |
| Placebo | Depression | 4.33 units on a scale | Standard Deviation 5.75 |
p-value: 0.05correlation
Secondary
Early Experience
The investigators will employ the Parental Bonding Instrument (Parker, Tupling, & Brown, 1979) to assess the early relationship experiences participants have with their caregivers. Existing research employing intranasal oxytocin suggests that the quality of early relationships may impact the strength of any modulation of brain or behavior by oxytocin administration and therefore this variable will be included in the analyses in support of this hypothesis. There are 12 items that capture parental care and 13 items that capture parental overprotection. Items are scored on a 4-point likert scale from very like to very unlike. The PBI is typically scored by identifying optimal (High Care Scores, Low Protection Scores) and less optimal (Low Care Scores, Low Protection Scores) scores on the mother and father subscales (NB: protection refers to overprotection). For the care items, scores can range from 0 to 36; for overprotection items, scores can range from 0 to 39.
Time frame: Within 20 minutes of study visit commencing
Population: Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss); 1 participant did not know their father and did not complete the measure for paternal assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxytocin | Early Experience | Maternal Care Score | 30.13 units on a scale | Standard Deviation 6.69 |
| Oxytocin | Early Experience | Paternal Care Score | 27.74 units on a scale | Standard Deviation 8.67 |
| Oxytocin | Early Experience | Maternal Protectiveness Score | 13.71 units on a scale | Standard Deviation 8.01 |
| Oxytocin | Early Experience | Paternal Protectiveness Score | 11.91 units on a scale | Standard Deviation 8.3 |
| Placebo | Early Experience | Paternal Protectiveness Score | 10.91 units on a scale | Standard Deviation 9.34 |
| Placebo | Early Experience | Maternal Care Score | 29.50 units on a scale | Standard Deviation 6.79 |
| Placebo | Early Experience | Maternal Protectiveness Score | 13.75 units on a scale | Standard Deviation 8.51 |
| Placebo | Early Experience | Paternal Care Score | 28.13 units on a scale | Standard Deviation 8.95 |
p-value: 0.05correlation
Secondary
Number of Participants Endorsing Substance Use
The investigators will employ the ASI Lite (McLellan, Luborsky, Woody, & O'Brien, 1980) to assess for current substance use. This measure is included to characterize the sample in respect of substance use; however the ASI Lite did not provide a measure of substance dependance and therefore we report the data from the Mini International Neuropsychiatric Interview substance dependance module (Sheehan et al., 1998) to provide a specific indication of the presence of absence of substance dependance.
Time frame: Within 30 minutes of study visit commencing
Population: 1 participant lost to follow-up; count of participants where substance dependence indicated
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oxytocin | Number of Participants Endorsing Substance Use | 0 Participants |
| Placebo | Number of Participants Endorsing Substance Use | 2 Participants |
Secondary
Number of Participants Testing Positive for Alcohol Use Following a Breathalyzer
Participants will complete an alcohol breathalyzer to characterize the alcohol use status of the sample.
Time frame: Within 30 minutes of study visit commencing
Population: 1 participant lost to follow-up; data indicates number of participants with alcohol in their system
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oxytocin | Number of Participants Testing Positive for Alcohol Use Following a Breathalyzer | 0 Participants |
| Placebo | Number of Participants Testing Positive for Alcohol Use Following a Breathalyzer | 0 Participants |
Secondary
Smoking
Participants will complete a CO breathalyzer and the Fagerstrom Test for Nicotine Dependence (Heatherton, Kozlowski, Frecker, & Fagerstrom, 1991) to assess smoking behavior. These measures are included to characterize the sample in respect of substance use.
Time frame: Within 30 minutes of study visit commencing
Population: 1 participant was lost to follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oxytocin | Smoking | CO indicated smoking status | 0 Participants |
| Oxytocin | Smoking | FTND indicated smoking status | 1 Participants |
| Placebo | Smoking | FTND indicated smoking status | 0 Participants |
| Placebo | Smoking | CO indicated smoking status | 0 Participants |
Secondary
Stress
The investigators will measure current levels of stress by using the Perceived Stress Scale (Cohen et al., 1983). It is not yet known the extent to which variation in perceived stress is associated with this methodology, but it is anticipated stress will be associated with levels of depression and anxiety in the sample. The PSS consists of 14 items, with scores ranging from 0 to 42, with higher scores indicating higher levels of perceived stress. A score of 21+ is considered to indicate that participants have higher than average stress.
Time frame: Within 20 minutes of study visit commencing
Population: Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Stress | 17.54 units on a scale | Standard Deviation 8.28 |
| Placebo | Stress | 18.13 units on a scale | Standard Deviation 8.23 |
p-value: 0.05correlation