NCT06822257

Brief Summary

This study examines the role of alcohol use in understanding the dynamics of romantic relationships. Couples will participate in a research session where they consume either an alcoholic or non-alcoholic beverage and complete study tasks. After the session, participants will provide information about their drinking habits, alcohol- and non-alcohol-related experiences, and relationship factors through brief surveys on their smart phones and again at 6-month and 12-month follow-up sessions. The findings from this study aim to improve understanding of alcohol use in close relationships and may inform future strategies for promoting healthier relationships and behaviors.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
504

participants targeted

Target at P75+ for not_applicable

Timeline
41mo left

Started Feb 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress28%
Feb 2025Sep 2029

First Submitted

Initial submission to the registry

January 24, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

4.6 years

First QC Date

January 24, 2025

Last Update Submit

May 22, 2025

Conditions

Keywords

alcohol administrationcouples

Outcome Measures

Primary Outcomes (5)

  • Social behaviors-observational

    Behavioral measures of social processes using validated and reliable behavioral coding schemes to code facial expressions, speech behaviors, and speech content: the Facial Action Coding System (Ekman, Friesen, \& Hagar, 2002) and the Rapid Marital Interaction Coding System (Heyman, 2004). This coding uses binary (yes/no) codes for presence/absence of behaviors at each moment in time. Higher scores represent more instances of behaviors.

    During couple interactions in the lab for a total duration of 55 minutes.

  • Emotions

    The 8-item Mood Measure (Fairbairn et al., 2021) will assess self-reported positive and negative emotions on scales from 0 (none) to 10 (extremely). Higher scores indicate a greater intensity of emotions.

    Immediately after the couple interactions in the lab referenced above.

  • Social behaviors-self-report

    Participants will provide ratings of their own and their partners' social behaviors on ten-point Likert scales. Higher scores indicate a greater endorsement of each behavior.

    Immediately after the couple interactions in the lab referenced above.

  • Real-world experiences

    Ecological Momentary Assessment (EMA) methods will be used to send a series of brief surveys to participants' smartphones to assess alcohol consumption (in standard alcoholic drinks).

    The EMA protocol will be completed for 14 days post-lab session.

  • Longer term alcohol problems

    Follow-up sessions will assess alcohol problems using DSM-5 alcohol use disorder criteria. Higher scores reflect more alcohol problems.

    Assessed longitudinally up to 12-months post-lab session.

Secondary Outcomes (1)

  • Relationship functioning

    Assessed longitudinally up to 12-months post-lab session.

Study Arms (1)

Healthy couples who drink alcohol

OTHER

Healthy young adult couples who regularly drink alcohol

Drug: Alcohol beverageOther: Non-alcohol beverage

Interventions

moderate dose of alcohol

Healthy couples who drink alcohol

No alcohol given

Healthy couples who drink alcohol

Eligibility Criteria

Age21 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Both members of the couple must:
  • be between the ages of 21 and 30
  • regularly consume alcohol
  • own a smartphone

You may not qualify if:

  • Neither member of the couple:
  • has a history of adverse reaction to the amount of beverage used in the study
  • has a history of major problems related to alcohol
  • is taking medications that could adversely interact with alcohol
  • is pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Alcohol DrinkingAlcoholic Intoxication

Interventions

EthanolBeverages

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Kasey G. Creswell, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychology; Director of Graduate Studies

Study Record Dates

First Submitted

January 24, 2025

First Posted

February 12, 2025

Study Start

February 1, 2025

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

Data will be shared in the NIAAA Data Archive

Locations