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Oxytocin, Alcohol Craving, and Intimate Partner Aggression

Primary Purpose

Alcohol Use

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Placebo
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use focused on measuring Couples, Oxytocin, Aggression, Alcohol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • Exclusion criteria include
  • pregnancy or breastfeeding
  • current or history of psychiatric or medical condition that could interfere with neuroendocrine function (e.g., hematological, endocrine, renal, or pulmonary disease; synthetic glucocorticoid or exogenous steroid therapy; psychotic, bipolar, eating disorders)
  • Body Max Index (BMI) ≥ 39
  • current suicidal ideation and intent
  • severe physical or sexual IPA in the past six months as defined by the Conflict Tactics Scale (CTS-2)
  • initiation of psychotropic medication in the past 4 weeks
  • acute alcohol withdrawal as indicated by a score of 8 or greater on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-Ar).

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oxytocin

Control

Arm Description

Each participant will self-administer 40 international units (IU) intranasal Oxytocin

Each participant will self-administer matching saline placebo

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 3, 2017
Last Updated
May 5, 2022
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT03046836
Brief Title
Oxytocin, Alcohol Craving, and Intimate Partner Aggression
Official Title
Effects of Oxytocin on Alcohol Craving and Intimate Partner Aggression
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
April 11, 2021 (Actual)
Study Completion Date
April 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use
Keywords
Couples, Oxytocin, Aggression, Alcohol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin
Arm Type
Experimental
Arm Description
Each participant will self-administer 40 international units (IU) intranasal Oxytocin
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Each participant will self-administer matching saline placebo
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Pitocin
Intervention Description
40 IU oxytocin nasal spray
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline
Primary Outcome Measure Information:
Title
Change in Alcohol Craving
Description
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).
Title
Laboratory Intimate Partner Aggression Intensity (IPA)
Description
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
Title
Laboratory Intimate Partner Aggression (IPA) Duration
Description
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
Secondary Outcome Measure Information:
Title
Change in Cortisol
Description
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).
Title
Change in Subjective Aggression
Description
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Exclusion criteria include pregnancy or breastfeeding current or history of psychiatric or medical condition that could interfere with neuroendocrine function (e.g., hematological, endocrine, renal, or pulmonary disease; synthetic glucocorticoid or exogenous steroid therapy; psychotic, bipolar, eating disorders) Body Max Index (BMI) ≥ 39 current suicidal ideation and intent severe physical or sexual IPA in the past six months as defined by the Conflict Tactics Scale (CTS-2) initiation of psychotropic medication in the past 4 weeks acute alcohol withdrawal as indicated by a score of 8 or greater on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-Ar).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julianne C Flanagan, Ph.D.
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Oxytocin, Alcohol Craving, and Intimate Partner Aggression

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