Alcohol Use
Conditions
Keywords
Couples, Oxytocin, Aggression, Alcohol
Brief summary
Alcohol use disorders (AUD) and intimate partner aggression (IPA) frequently co-occur. There are significant health and economic burdens associated with AUD and co-occurring IPA, and little empirical data to guide treatment efforts. The neuropeptide oxytocin may help mitigate both AUD and IPA. However, clinical data examining oxytocin's effects on human aggression is scant. The proposed study is designed to address these gaps in the literature by utilizing a human laboratory paradigm to test the effects of oxytocin on craving and aggression among couples with AUD and co-occurring IPA.
Interventions
DRUGOxytocin
40 IU oxytocin nasal spray
DRUGPlacebo
Saline
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inclusion criteria indicate that participants must * aged 18 or over * fluent in English * endorse at least one instance of mild or moderate physical IPA with their partner in the past 6 months as defined by the Revised Conflict Tactics Scale (CTS-2) * both partners must be willing to participate * one or both partners must meet Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for an alcohol use disorder (AUD). Concurrent substance use disorders (e.g., marijuana) is acceptable provided alcohol is the participant's primary substance of choice.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Alcohol Craving | Participants completed the VAS at 8 timepoints. Outcome measure represents the change in VAS scores between time point 3 (before the alcohol cue) and 4 (after the alcohol cue). | Change in subjective alcohol craving as measured by a Visual Analogue Scale (VAS) between time point 3 (before the alcohol cue) and 4 (after the alcohol cue). Participants completed the VAS at 8 timepoints: Minute 0 (pre-OT/placebo) (Time 1) Minute 5 (pre-OT/placebo) (Time 2) OT/placebo administered at minute 10 Minute 40 (Time 3) Minute 45 - alcohol cue paradigm began Time 4 (immediately after alcohol cue) Minute 65 - TAP began Time 5 (immediately after TAP began) Time 6 (15 minutes after TAP) Time 7 (30 minutes after TAP) Time 8 (60 minutes after TAP) This 100mm Visual Analogue Scale (VAS) was anchored on a 100mm Likert-type scale from 0 (not at all/no craving) to 10 (extremely/maximum carving). The scale is set to 100mm in length, and the lowest value is a 0 (zero), representing no craving and and highest value is a 10 (ten) representing extreme craving. |
| Laboratory Intimate Partner Aggression Intensity (IPA) | 10 minutes from start to end of TAP | Intensity of laboratory-based IPA was assessed using the Taylor Aggression Paradigm (TAP). IPA intensity is operationalized as the volume of shock administered on a 1-10 (1 is least intense, 10 is most intense) scale using the computer based paradigm in response to losing trials. TAP is a fictitious reaction time competition among partners. Participants are told that a winning trial required them to deliver a shock to their partner that ranged from 1 to 10 intensity for a duration of their choosing. A losing trial resulted in them receiving a shock from their partner (administered through two electrodes attached to the index and middle fingers of the nondominant hand). In reality, all participants received an identical sequence of winning or losing trials (and corresponding shocks) generated by the TAP software. IPA was operationalized as the average intensity (volume) and duration of shocks administered in response to losing trials. |
| Laboratory Intimate Partner Aggression (IPA) Duration | 10 minutes from start to end of TAP | Laboratory IPA Duration was measured by the length of time participants administered shocks in the Taylor Aggression Paradigm (TAP). Measured in milliseconds. Greater number of milliseconds represents a longer shock. TAP is a fictitious reaction time competition among partners. Participants are told that a winning trial required them to deliver a shock to their partner that ranged from 1 to 10 intensity for a duration of their choosing. A losing trial resulted in them receiving a shock from their partner (administered through two electrodes attached to the index and middle fingers of the nondominant hand). In reality, all participants received an identical sequence of winning or losing trials (and corresponding shocks) generated by the TAP software. IPA was operationalized as the average intensity (volume) and duration of shocks administered in response to losing trials. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cortisol | Measured between Time 4 (before the laboratory aggression paradigm) and Time 5 (after the laboratory aggression paradigm). | Change in salivary cortisol measured between Time 4 (before the laboratory aggression paradigm) and Time 5 (after the laboratory aggression paradigm). Participants completed the VAS at 8 timepoints: Minute 0 (pre-OT/placebo) (Time 1) Minute 5 (pre-OT/placebo) (Time 2) OT/placebo administered at minute 10 Minute 40 (Time 3) Minute 45 - alcohol cue paradigm began Time 4 (immediately after alcohol cue) Minute 65 - TAP began Time 5 (immediately after TAP began) Time 6 (15 minutes after TAP) Time 7 (30 minutes after TAP) Time 8 (60 minutes after TAP) Higher salivary cortisol is indicative of higher stress response and lower salivary cortisol is indicative of lower stress response. |
| Change in Subjective Aggression | Change is aggression measured between time point 4 (after the alcohol cue) and 5 (during Taylor Aggression Paradigm). | Mean change in subjective aggression scores as measured by a Visual Analogue Scale (VAS) between time point 4 (after alcohol cue) and 5 (during Taylor Aggression Paradigm, TAP). Participants completed the VAS at 8 timepoints: Minute 0 (pre-OT/placebo) (Time 1) Minute 5 (pre-OT/placebo) (Time 2) OT/placebo administered at minute 10 Minute 40 (Time 3) Minute 45 - alcohol cue paradigm began Time 4 (immediately after alcohol cue) Minute 65 - TAP began Time 5 (immediately after TAP began) Time 6 (15 minutes after TAP) Time 7 (30 minutes after TAP) Time 8 (60 minutes after TAP) This 100mm Visual Analogue Scale (VAS) was anchored on a Likert-type scale from 0 (not at all/no aggression) to 10 (extremely/maximum aggression). The scale is set to 100mm in length, and the lowest value is a 0 (zero), representing no aggression and and highest value is a 10 (ten) representing extreme aggression. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from July 2017 through April 2021. Participants were recruited from local clinics, by using social media advertisements, and from the investigator's previous trials.
Pre-assignment details
One hundred couples (N = 200 individuals) were enrolled using 1:1 randomization. Both partners within a couple were assigned to the same condition (oxytocin or placebo). Inclusion criteria indicated that one or both partners in each couple met DSM-5 criteria for current AUD and endorsed physical intimate partner aggression (IPA i.e., hitting, slapping) that occurred at any point during their current relationship, as assessed by the Revised Conflict Tactics Scale.
Participants by arm
| Arm | Count |
|---|---|
| Oxytocin Each participant will self-administer 40 IU intranasal Oxytocin
Oxytocin: 40 IU oxytocin nasal spray | 100 |
| Control Each participant will self-administer matching saline placebo
Placebo: Saline | 100 |
| Total | 200 |
Baseline characteristics
| Characteristic | Oxytocin | Total | Control |
|---|---|---|---|
| Age, Continuous | 36.2 years STANDARD_DEVIATION 11.5 | 35.4 years STANDARD_DEVIATION 113 | 34.6 years STANDARD_DEVIATION 11 |
| Alcohol Use Disorder (AUD) Mild | 30 Participants | 50 Participants | 20 Participants |
| Alcohol Use Disorder (AUD) Moderate | 14 Participants | 33 Participants | 19 Participants |
| Alcohol Use Disorder (AUD) No AUD | 19 Participants | 43 Participants | 24 Participants |
| Alcohol Use Disorder (AUD) Severe | 37 Participants | 74 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 14 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 91 Participants | 184 Participants | 93 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants | 44 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 11 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 64 Participants | 138 Participants | 74 Participants |
| Relationship Status Cohabitating | 47 Participants | 90 Participants | 43 Participants |
| Relationship Status Dating | 7 Participants | 22 Participants | 15 Participants |
| Relationship Status Divorced | 1 Participants | 3 Participants | 2 Participants |
| Relationship Status Married | 39 Participants | 71 Participants | 32 Participants |
| Relationship Status Missing | 3 Participants | 5 Participants | 2 Participants |
| Relationship Status Separated | 1 Participants | 3 Participants | 2 Participants |
| Relationship Status Single | 2 Participants | 6 Participants | 4 Participants |
| Sex: Female, Male Female | 53 Participants | 106 Participants | 53 Participants |
| Sex: Female, Male Male | 47 Participants | 94 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 100 |
| other Total, other adverse events | 0 / 100 | 6 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
Primary
Change in Alcohol Craving
Change in subjective alcohol craving as measured by a Visual Analogue Scale (VAS) between time point 3 (before the alcohol cue) and 4 (after the alcohol cue). Participants completed the VAS at 8 timepoints: Minute 0 (pre-OT/placebo) (Time 1) Minute 5 (pre-OT/placebo) (Time 2) OT/placebo administered at minute 10 Minute 40 (Time 3) Minute 45 - alcohol cue paradigm began Time 4 (immediately after alcohol cue) Minute 65 - TAP began Time 5 (immediately after TAP began) Time 6 (15 minutes after TAP) Time 7 (30 minutes after TAP) Time 8 (60 minutes after TAP) This 100mm Visual Analogue Scale (VAS) was anchored on a 100mm Likert-type scale from 0 (not at all/no craving) to 10 (extremely/maximum carving). The scale is set to 100mm in length, and the lowest value is a 0 (zero), representing no craving and and highest value is a 10 (ten) representing extreme craving.
Time frame: Participants completed the VAS at 8 timepoints. Outcome measure represents the change in VAS scores between time point 3 (before the alcohol cue) and 4 (after the alcohol cue).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Change in Alcohol Craving | 0.90 score on a scale | Standard Error 0.12 |
| Control | Change in Alcohol Craving | 1.21 score on a scale | Standard Error 0.12 |
Primary
Laboratory Intimate Partner Aggression Intensity (IPA)
Intensity of laboratory-based IPA was assessed using the Taylor Aggression Paradigm (TAP). IPA intensity is operationalized as the volume of shock administered on a 1-10 (1 is least intense, 10 is most intense) scale using the computer based paradigm in response to losing trials. TAP is a fictitious reaction time competition among partners. Participants are told that a winning trial required them to deliver a shock to their partner that ranged from 1 to 10 intensity for a duration of their choosing. A losing trial resulted in them receiving a shock from their partner (administered through two electrodes attached to the index and middle fingers of the nondominant hand). In reality, all participants received an identical sequence of winning or losing trials (and corresponding shocks) generated by the TAP software. IPA was operationalized as the average intensity (volume) and duration of shocks administered in response to losing trials.
Time frame: 10 minutes from start to end of TAP
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Laboratory Intimate Partner Aggression Intensity (IPA) | 4.8 units on a scale | Standard Deviation 2.2 |
| Control | Laboratory Intimate Partner Aggression Intensity (IPA) | 4.3 units on a scale | Standard Deviation 2 |
Primary
Laboratory Intimate Partner Aggression (IPA) Duration
Laboratory IPA Duration was measured by the length of time participants administered shocks in the Taylor Aggression Paradigm (TAP). Measured in milliseconds. Greater number of milliseconds represents a longer shock. TAP is a fictitious reaction time competition among partners. Participants are told that a winning trial required them to deliver a shock to their partner that ranged from 1 to 10 intensity for a duration of their choosing. A losing trial resulted in them receiving a shock from their partner (administered through two electrodes attached to the index and middle fingers of the nondominant hand). In reality, all participants received an identical sequence of winning or losing trials (and corresponding shocks) generated by the TAP software. IPA was operationalized as the average intensity (volume) and duration of shocks administered in response to losing trials.
Time frame: 10 minutes from start to end of TAP
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Laboratory Intimate Partner Aggression (IPA) Duration | 405.5 milliseconds | Standard Deviation 113.2 |
| Control | Laboratory Intimate Partner Aggression (IPA) Duration | 414.4 milliseconds | Standard Deviation 117 |
Secondary
Change in Cortisol
Change in salivary cortisol measured between Time 4 (before the laboratory aggression paradigm) and Time 5 (after the laboratory aggression paradigm). Participants completed the VAS at 8 timepoints: Minute 0 (pre-OT/placebo) (Time 1) Minute 5 (pre-OT/placebo) (Time 2) OT/placebo administered at minute 10 Minute 40 (Time 3) Minute 45 - alcohol cue paradigm began Time 4 (immediately after alcohol cue) Minute 65 - TAP began Time 5 (immediately after TAP began) Time 6 (15 minutes after TAP) Time 7 (30 minutes after TAP) Time 8 (60 minutes after TAP) Higher salivary cortisol is indicative of higher stress response and lower salivary cortisol is indicative of lower stress response.
Time frame: Measured between Time 4 (before the laboratory aggression paradigm) and Time 5 (after the laboratory aggression paradigm).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Oxytocin | Change in Cortisol | 0.11 ul/dL |
| Control | Change in Cortisol | 0.11 ul/dL |
Secondary
Change in Subjective Aggression
Mean change in subjective aggression scores as measured by a Visual Analogue Scale (VAS) between time point 4 (after alcohol cue) and 5 (during Taylor Aggression Paradigm, TAP). Participants completed the VAS at 8 timepoints: Minute 0 (pre-OT/placebo) (Time 1) Minute 5 (pre-OT/placebo) (Time 2) OT/placebo administered at minute 10 Minute 40 (Time 3) Minute 45 - alcohol cue paradigm began Time 4 (immediately after alcohol cue) Minute 65 - TAP began Time 5 (immediately after TAP began) Time 6 (15 minutes after TAP) Time 7 (30 minutes after TAP) Time 8 (60 minutes after TAP) This 100mm Visual Analogue Scale (VAS) was anchored on a Likert-type scale from 0 (not at all/no aggression) to 10 (extremely/maximum aggression). The scale is set to 100mm in length, and the lowest value is a 0 (zero), representing no aggression and and highest value is a 10 (ten) representing extreme aggression.
Time frame: Change is aggression measured between time point 4 (after the alcohol cue) and 5 (during Taylor Aggression Paradigm).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Change in Subjective Aggression | 0.31 score on a scale | Standard Error 0.1 |
| Control | Change in Subjective Aggression | 0.41 score on a scale | Standard Error 0.09 |