Oxytocin, Alcohol Craving, and Intimate Partner Aggression

NCT03046836 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 54689
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use

Keywords

Couples; Oxytocin; Aggression; Alcohol

Outcome Measures

Primary Outcomes (3)

• 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.

  10 minutes from start to end of TAP

Secondary Outcomes (2)

• Change in Cortisol

  Measured between Time 4 (before the laboratory aggression paradigm) and Time 5 (after the laboratory aggression paradigm).

• Change in Subjective Aggression

  Change is aggression measured between time point 4 (after the alcohol cue) and 5 (during Taylor Aggression Paradigm).

Study Arms (2)

Oxytocin

EXPERIMENTAL

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

Drug: Oxytocin

Control

PLACEBO COMPARATOR

Each participant will self-administer matching saline placebo

Drug: Placebo

Interventions

Oxytocin DRUG

40 IU oxytocin nasal spray

Also known as: Pitocin

Oxytocin

Placebo DRUG

Saline

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (2)

• 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. doi: 10.1037/tra0002057. Online ahead of print.

  PMID: 41129363 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.

  PMID: 40392716 DERIVED

MeSH Terms

Conditions

Alcohol Drinking; Aggression

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Social Behavior

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Ability to estimate anticipated power was limited by absence of prior studies examining effects of OT on aggression using TAP.

Results Point of Contact

• Title: Stacey Sellers
• Organization: Medical University of South Carolina - Institute of Psychiatry

sellersst@musc.edu

8437925807

Study Officials

• Julianne C Flanagan, Ph.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 8, 2017
• Study Start: July 1, 2017
• Primary Completion: April 11, 2021
• Study Completion: April 11, 2021
• Last Updated: May 9, 2022
• Results First Posted: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)