Oxytocin, Alcohol Craving, and Intimate Partner Aggression

Overview

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.

Full Title of Study: “Effects of Oxytocin on Alcohol Craving and Intimate Partner Aggression”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 31, 2020

Interventions

  • Drug: Oxytocin
    • 40 IU oxytocin nasal spray
  • Drug: Placebo
    • Saline

Arms, Groups and Cohorts

  • Experimental: Oxytocin
    • Each participant will self-administer 40 IU intranasal Oxytocin
  • Placebo Comparator: Control
    • Each participant will self-administer matching saline placebo

Clinical Trial Outcome Measures

Primary Measures

  • Alcohol Craving
    • Time Frame: 2 hours
    • Subjective alcohol craving Measured on a Likert-type scale of 1-10

Secondary Measures

  • Cortisol
    • Time Frame: 2 hours
    • Salivary cortisol
  • Aggression
    • Time Frame: 2 hours
    • Laboratory-based aggression paradigm

Participating in This Clinical Trial

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 DSM-V diagnostic 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)
  • BMI ≥ 39
  • current suicidal ideation and intent
  • severe physical or sexual IPA in the past six months as defined by the 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 CIWA-Ar.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of South Carolina
  • Provider of Information About this Clinical Study
    • Principal Investigator: Julianne Flanagan, Assistant Professor – Medical University of South Carolina
  • Overall Official(s)
    • Julianne C Flanagan, Ph.D., Principal Investigator, Medical University of South Carolina
  • Overall Contact(s)
    • Julianne C Flanagan, Ph.D., 843-792-5569, Hellmuth@musc.edu

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