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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Oxytocin, Alcohol Craving, and Intimate Partner Aggression

NCTNCT03046836 (opens ClinicalTrials.gov in a new tab)Other id54689
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
200 participants (actual)
Sponsor
Medical University of South Carolina · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
1 Jul 2017
Primary completion
11 Apr 2021
Completion
11 Apr 2021
First posted
8 Feb 2017 (estimated)
Last update posted
9 May 2022
Conditions
Alcohol Use

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201720182019202020212022
  1. Ph 2

    Oxytocin, Alcohol Craving, and Intimate Partner Aggression

    NCT03046836

    1 Jul 2017 to 11 Apr 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • OxytocinDrug
  • PlaceboDrug

Arms2

  • Experimental

    Oxytocin

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

  • Placebo comparator

    Control

    Each participant will self-administer matching saline placebo

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Change in Alcohol 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).

    Registry 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.

  2. Laboratory Intimate Partner Aggression Intensity (IPA)

    Time frame · 10 minutes from start to end of TAP

    Registry 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.

  3. Laboratory Intimate Partner Aggression (IPA) Duration

    Time frame · 10 minutes from start to end of TAP

    Registry 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.

Secondary outcomes(2)

  1. Change in Cortisol

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

    Registry 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.

  2. Change in Subjective Aggression

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

    Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 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 Alcohol Craving

GroupValue (score on a scale)Spread
Oxytocin0.900.12
Control1.210.12
Primary outcomeMean· 10 minutes from start to end of TAP

Laboratory Intimate Partner Aggression Intensity (IPA)

GroupValue (units on a scale)Spread
Oxytocin4.82.2
Control4.32.0
Primary outcomeMean· 10 minutes from start to end of TAP

Laboratory Intimate Partner Aggression (IPA) Duration

GroupValue (milliseconds)Spread
Oxytocin405.5113.2
Control414.4117.0
Secondary and other outcome results(2)
Secondary outcomeMean· Measured between Time 4 (before the laboratory aggression paradigm) and Time 5 (after the laboratory aggression paradigm).

Change in Cortisol

GroupValue (ul/dL)
Oxytocin0.11
Control0.11
Secondary outcomeMean· Change is aggression measured between time point 4 (after the alcohol cue) and 5 (during Taylor Aggression Paradigm).

Change in Subjective Aggression

GroupValue (score on a scale)Spread
Oxytocin0.310.10
Control0.410.09

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
OxytocinEach participant will self-administer 40 IU intranasal Oxytocin Oxytocin: 40 IU oxytocin nasal spray0 / 1000 / 1000 / 100
ControlEach participant will self-administer matching saline placebo Placebo: Saline0 / 1000 / 1006 / 100

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2025

5 results

Results of a Randomized Controlled Trial Examining the Efficacy of Intranasal Oxytocin to Enhance Alcohol Behavioral Couple Therapy.

Flanagan et al. 2025The Journal of clinical psychiatrycited by 3

PMID 40392716PMC12766540DOI 10.4088/jcp.24m15627PUB-40392716

Rights unknown5 results
Source linkSee results (5)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedHurd 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 4:10.1002/jclp.70179. doi: 10.1002/jclp.70179. Online ahead of print. PMID 42400312
  • DerivedForkus 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. PMID 41129363

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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).

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