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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin | Experimental | Each participant will self-administer 40 international units (IU) intranasal Oxytocin |
|
| Control | Placebo Comparator | Each participant will self-administer matching saline placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | 40 IU oxytocin nasal spray |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
| 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. | 10 minutes from start to end of TAP |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julianne C Flanagan, Ph.D. | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42400312 | Derived | Hurd JA, Giff ST, Hall E, Thomas M, Noblejas-Guloy R, Flanagan JC. Single Versus Multiple Intimate Partner Violence Relationships: Current Severity of Psychological Distress Among Romantic Partners. J Clin Psychol. 2026 Jul 4. doi: 10.1002/jclp.70179. Online ahead of print. | |
| 41129363 | Derived | Forkus SR, Baer MM, Giff ST, Hall E, Miles SR, Flanagan JC. The role of cognitive emotion regulation strategies on posttraumatic stress symptoms and alcohol use problems among individuals experiencing intimate partner violence. Psychol Trauma. 2025 Oct 23:10.1037/tra0002057. doi: 10.1037/tra0002057. Online ahead of print. |
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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 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxytocin | Each participant will self-administer 40 IU intranasal Oxytocin Oxytocin: 40 IU oxytocin nasal spray |
| FG001 | Control | Each participant will self-administer matching saline placebo Placebo: Saline |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxytocin | Each participant will self-administer 40 IU intranasal Oxytocin Oxytocin: 40 IU oxytocin nasal spray |
| BG001 | Control | Each participant will self-administer matching saline placebo Placebo: Saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | score on a scale | 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). |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxytocin | Each participant will self-administer 40 IU intranasal Oxytocin Oxytocin: 40 IU oxytocin nasal spray |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lightheadedness | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
Ability to estimate anticipated power was limited by absence of prior studies examining effects of OT on aggression using TAP.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stacey Sellers | Medical University of South Carolina - Institute of Psychiatry | 8437925807 | sellersst@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 13, 2020 | Mar 21, 2022 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 6, 2020 | Feb 8, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D000374 | Aggression |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Placebo | Drug | Saline |
|
| 10 minutes from start to end of TAP |
| Measured between Time 4 (before the laboratory aggression paradigm) and Time 5 (after the laboratory aggression paradigm). |
| 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. | Change is aggression measured between time point 4 (after the alcohol cue) and 5 (during Taylor Aggression Paradigm). |
| 40392716 | Derived | Flanagan JC, Nietert PJ, McCrady BS, Sellers S, Yates-Johnson A, Giff ST, Forkus SR. Results of a Randomized Controlled Trial Examining the Efficacy of Intranasal Oxytocin to Enhance Alcohol Behavioral Couple Therapy. J Clin Psychiatry. 2025 May 12;86(2):24m15627. doi: 10.4088/JCP.24m15627. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Relationship Status | Count of Participants | Participants |
|
| Alcohol Use Disorder (AUD) | Count of Participants | Participants |
|
| OG000 |
| Oxytocin |
Each participant will self-administer 40 IU intranasal Oxytocin (OT) Oxytocin: 40 IU oxytocin nasal spray |
| OG001 | Control | Each participant will self-administer matching saline placebo Placebo: Saline |
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 10 minutes from start to end of TAP |
|
|
|
| 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. | Posted | Mean | Standard Deviation | milliseconds | 10 minutes from start to end of TAP |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | ul/dL | Measured between Time 4 (before the laboratory aggression paradigm) and Time 5 (after the laboratory aggression paradigm). |
|
|
|
| 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. | Posted | Mean | Standard Error | score on a scale | Change is aggression measured between time point 4 (after the alcohol cue) and 5 (during Taylor Aggression Paradigm). |
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| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Control | Each participant will self-administer matching saline placebo Placebo: Saline | 0 | 100 | 0 | 100 | 6 | 100 |
| Upper Respiratory Infection | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment | Nosebleed |
|
| Accident | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment | 1- car accident 1 - finger laceration |
|
| Cholecystectomy | Surgical and medical procedures | MedDRA | Non-systematic Assessment | planned procedure |
|
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| D012919 |
| Social Behavior |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |