Heavy Episodic DrinkingNCT06976528
Understanding the Associations Between Romantic Relationship Conflict, Psychophysiological Responding and Alcohol Misuse Among Emerging Adults
A study testing Alcohol administration in people with Heavy Episodic Drinking, run by New York University at 1 site in United States.
Trial summary
Emerging Adults (EA) engage in heavy episodic drinking (HED) at a greater quantity and frequency than any other time in their lives, which may lead to significant short- and long-term consequences. Read more about this study
- Who is it for?
- Ages 21 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Heavy Episodic Drinking
- What is being tested?
- Alcohol administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2025to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 21-29 years old
- Must be in a committed romantic relationship of at least 3 months duration
- Must report at least 2 HED episodes in the past 30 days (5 or more drinks within 2 hours for males, 4 or more drinks within 2 hours for females)
- Must self-report that they have - on at least three occasions during the past year - consumed a quantity of alcohol that is equal to or greater than the standard dose administered for their weight in the laboratory
Who cannot join
- Meeting DSM-5 criteria for a history of or current neurological, psychotic, or bipolar disorders
- History of self-reported head trauma requiring medical treatment
- Body weight exceeding 250 pounds
- Current enrollment in treatment or seeking treatment for a substance or alcohol use disorder
- Current suicidal or homicidal intent
- Serious cardiovascular health conditions (e.g. pacemaker, cardiac arrhythmia, hypertension) that may alter normative cardiac functioning
Show all 13Show fewer
- Treatment on medications such as lithium, methadone, alpha or beta blockers or cholinergic/anticholinergic medications likely to confound normative cardiovascular responding or response to alcohol administration. Stimulant or benzodiazepine medication use is permissible provided participants do not take medication on the day of study participation
- Severe and/or unilateral physical IPV with your current partner at any time
- Sexual IPV with current partner at any time
- Fear of current partner
- Pregnancy or breastfeeding
- Severe Alcohol Use Disorder (as defined by the DSM-5)
- Current diagnosis of anorexia or bulimia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
386 Park Avenue South
New York, New York, 10016
Sarah Harris, 914-419-4745, sh8527@nyu.edu
About this study
Emerging Adults (EA) engage in heavy episodic drinking (HED) at a greater quantity and frequency than any other time in their lives, which may lead to significant short- and long-term consequences. Although much is known about the influence of peers in EA alcohol use, there is a dearth of research examining the ways in which romantic partners influence EA drinking behaviors. The proposed study bridges a crucial gap in the existing literature by examining behavioral and physiological risk and resilience factors in the acute link between EA relationship conflict and alcohol consumption. EA couples will engage in two conflict resolution tasks interspersed with two puzzle tasks and two alcohol administration procedures. Because high frequency heart rate variability (HF-HRV) is associated with alcohol use and emotion regulation during stressful experiences, HF-HRV and other physiological data will be collected throughout the laboratory procedures.
- Conditions
- Heavy Episodic Drinking
- Being tested
- Alcohol administration
- Keywords
- couples, emerging adults, young adults, binge drinking, alcohol use, conflict
- Medical subject headings
- Binge Drinking, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol administrationOther
In this study, participants complete two tasks, then are administered alcohol. Next, they repeat the tasks.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | This is the only arm of the study. All participants receive the alcohol administration intervention. Receives: Other: Alcohol administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol consumption
Amount of alcohol consumed during the study
Measured: ~20 minutes
Secondary outcomes (1)
High frequency heart rate variability (HF-HRV)
High frequency heart rate variability (HF-HRV) is a neurally-derived measure of parasympathetic activity that may partially explain the association between stressful relationship conflict and alcohol misuse. HF-HRV is a measure of the variability in interbeat intervals, or the time in between beats of the heart.
Measured: ~3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start26 Sep 2025
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy Episodic DrinkingStudies of the same condition, open and under way.
- More trials run by New York UniversityThe 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976528
- Sponsor's protocol ID
- 20237802
- Other IDs
- 5K23AA030328
- Status last verified
- Sep 2025
- First submitted
- 8 May 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Associations Between Romantic Relationship Conflict, Psychophysiological Responding and Alcohol Misuse Among Emerging Adults
- ClinicalTrials.gov ID
- NCT06976528
- Acronym / sponsor ID
- 20237802
- Conditions
- Heavy Episodic Drinking
- Keywords
- couples, emerging adults, young adults, binge drinking, alcohol use, conflict
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Emerging Adults (EA) engage in heavy episodic drinking (HED) at a greater quantity and frequency than any other time in their lives, which may lead to significant short- and long-term consequences. Although much is known about the influence of peers in EA alcohol use, there is a dearth of research examining the ways in which romantic partners influence EA drinking behaviors. The proposed study bridges a crucial gap in the existing literature by examining behavioral and physiological risk and resilience factors in the acute link between EA relationship conflict and alcohol consumption. EA couples will engage in two conflict resolution tasks interspersed with two puzzle tasks and two alcohol administration procedures. Because high frequency heart rate variability (HF-HRV) is associated with alcohol use and emotion regulation during stressful experiences, HF-HRV and other physiological data will be collected throughout the laboratory procedures.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Other: Alcohol administrationThis is the only arm of the study. All participants receive the alcohol administration intervention. |
Who may qualify
- Ages
- 21 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 21-29 years old
- Must be in a committed romantic relationship of at least 3 months duration
- Must report at least 2 HED episodes in the past 30 days (5 or more drinks within 2 hours for males, 4 or more drinks within 2 hours for females)
- Must self-report that they have - on at least three occasions during the past year - consumed a quantity of alcohol that is equal to or greater than the standard dose administered for their weight in the laboratory
Key exclusion criteria (13 listed)
- Meeting DSM-5 criteria for a history of or current neurological, psychotic, or bipolar disorders
- History of self-reported head trauma requiring medical treatment
- Body weight exceeding 250 pounds
- Current enrollment in treatment or seeking treatment for a substance or alcohol use disorder
- Current suicidal or homicidal intent
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 |
|---|---|---|
| Alcohol administrationIn this study, participants complete two tasks, then are administered alcohol. Next, they repeat the tasks. | Other | Single Arm |
Primary outcome
Alcohol consumption
Time frame: ~20 minutes
Amount of alcohol consumed during the study
1 secondary outcome
High frequency heart rate variability (HF-HRV)
Time frame: ~3 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol administration in people with Heavy Episodic Drinking, run by New York University 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 4 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol consumption (time frame: ~20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2026.