Alcohol UsePhase 2NCT03046836

Oxytocin, Alcohol Craving, and Intimate Partner Aggression

A Phase 2 study testing Oxytocin in people with Alcohol Use, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Alcohol Use
What is being tested?: Oxytocin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 200 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2017to 11 Apr 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical University of South Carolina
Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: Effects of Oxytocin on Alcohol Craving and Intimate Partner Aggression

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
Being tested: Oxytocin, Placebo
Keywords: Couples, Oxytocin, Aggression, Alcohol
Medical subject headings: Alcohol Drinking, Aggression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OxytocinDrug
Also called Pitocin
40 IU oxytocin nasal spray
PlaceboDrug
Saline

Study groups in NCT03046836
Study group	Role	What they receive
Oxytocin	Experimental	Each participant will self-administer 40 international units (IU) intranasal Oxytocin Receives: Drug: Oxytocin
Control	Placebo comparator	Each participant will self-administer matching saline placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 10 minutes from start to end of TAP

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 201711 Apr 2021

First posted8 Feb 2017 (estimated)
Study start1 Jul 2017
Primary completion11 Apr 2021
Study completion11 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Alcohol UseStudies of the same condition, open and under way.
More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03046836
Sponsor's protocol ID: 54689
Status last verified: May 2022
First submitted: 3 Feb 2017
Last updated: 9 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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 4:10.1002/jclp.70179. doi: 10.1002/jclp.70179. Online ahead of print.
PubMed 42400312
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.
PubMed 41129363
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.
PubMed 40392716

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Alcohol Use trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Oxytocin on Alcohol Craving and Intimate Partner Aggression
ClinicalTrials.gov ID: NCT03046836
Acronym / sponsor ID: 54689
Conditions: Alcohol Use
Keywords: Couples, Oxytocin, Aggression, Alcohol
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Study start: 1 Jul 2017 (actual)
Primary completion: 11 Apr 2021 (actual)
Study completion: 11 Apr 2021 (actual)
First posted: 8 Feb 2017 (estimated)
Results: Posted 9 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Oxytocin	Experimental	Drug: OxytocinEach participant will self-administer 40 international units (IU) intranasal Oxytocin
Control	Placebo comparator	Drug: PlaceboEach participant will self-administer matching saline placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (7 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OxytocinAlso: Pitocin40 IU oxytocin nasal spray	Drug	Oxytocin
PlaceboSaline	Drug	Control

Primary outcome

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).
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)
Time frame: 10 minutes from start to end of TAP
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
Time frame: 10 minutes from start to end of TAP
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.

2 secondary outcomes

Change in Cortisol
Time frame: Measured between Time 4 (before the laboratory aggression paradigm) and Time 5 (after the laboratory aggression paradigm).
Change in Subjective Aggression
Time frame: Change is aggression measured between time point 4 (after the alcohol cue) and 5 (during Taylor Aggression Paradigm).

Results and safety

Results posted to the registry on 9 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oxytocin	100	100
Control	100	100

Primary outcome: 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).. Mean (Standard Error). Unit: score on a scale

Measure	Oxytocin n = 100	Control n = 100
Value	0.90 (0.12)	1.21 (0.12)

Primary outcome: Laboratory Intimate Partner Aggression Intensity (IPA)

Time frame: 10 minutes from start to end of TAP. Mean (Standard Deviation). Unit: units on a scale

Measure	Oxytocin n = 100	Control n = 100
Value	4.8 (2.2)	4.3 (2.0)

Primary outcome: Laboratory Intimate Partner Aggression (IPA) Duration

Time frame: 10 minutes from start to end of TAP. Mean (Standard Deviation). Unit: milliseconds

Measure	Oxytocin n = 100	Control n = 100
Value	405.5 (113.2)	414.4 (117.0)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 month. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oxytocin	0 of 100 (0%)	0 of 100 (0%)	0 of 100
Control	0 of 100 (0%)	6 of 100 (6%)	0 of 100

Limitations and caveats (from the sponsor): Ability to estimate anticipated power was limited by absence of prior studies examining effects of OT on aggression using TAP.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42400312Hurd 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.
Derived from this study: PubMed 41129363Forkus 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.
Derived from this study: PubMed 40392716Flanagan 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Julianne C Flanagan, Ph.D. principal investigator

Medical University of South Carolina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxytocin in people with Alcohol Use, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03046836, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.