Alcohol ConsumptionNCT06822257
Drinking in Young Adult Duos (DYAD) Study
A study testing Alcohol beverage and Non-alcohol beverage in people with Alcohol Consumption and Alcohol Drinking, run by Carnegie Mellon University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Consumption, Alcohol Drinking, Alcohol Intoxication
- What is being tested?
- Alcohol beverage and Non-alcohol beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to Sep 2029
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both members of the couple must:
- be between the ages of 21 and 30
- regularly consume alcohol
- own a smartphone
Who cannot join
- 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
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
Carnegie Mellon University
Pittsburgh, Pennsylvania, 15213
Kasey Creswell, PhD, 1-412-779-4931, kasey@andrew.cmu.edu
Kasey G. Creswell, PhD
About this study
Official title: Understanding Alcohol Use in Young Adult Couples
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.
Read the detailed description
This study investigates alcohol consumption in romantic relationships. Couples will be recruited to participate in a laboratory-based alcohol administration session, during which they will consume either a moderate dose of alcohol or a non-alcoholic beverage. Following beverage consumption, couples will complete questionnaires and tasks.
The study employs a multi-method approach to assess alcohol in couples, including self-reports and behavioral tasks, both inside and outside of the lab (e.g., using ecological momentary assessment). Additionally, participants' drinking patterns and relationship factors will be tracked over time, with follow-up assessments conducted at 6-months and 12 months post-laboratory session.
The findings from this research will provide insights into the role that alcohol consumption plays in close relationships and may inform interventions to support healthier drinking behaviors and relationship outcomes.
- Conditions
- Alcohol Consumption, Alcohol Drinking, Alcohol Intoxication
- Being tested
- Alcohol beverage, Non-alcohol beverage
- Keywords
- alcohol administration, couples
- Medical subject headings
- Alcohol Drinking, Alcoholic Intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol beverageDrug
moderate dose of alcohol
Non-alcohol beverageOther
No alcohol given
| Study group | Role | What they receive |
|---|---|---|
| Healthy couples who drink alcohol | Other | Healthy young adult couples who regularly drink alcohol Receives: Drug: Alcohol beverage; Other: Non-alcohol beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Assessed longitudinally up to 12-months post-lab session.
Secondary outcomes (1)
Relationship functioning
Relationship functioning will be assessed on 10 point Likert scales (Jakubiak \& Feeney, 2009), with higher scores representing higher relationship functioning.
Measured: Assessed longitudinally up to 12-months post-lab session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Feb 2025
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- 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
- 504 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carnegie Mellon University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Kasey Creswell, Carnegie Mellon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822257
- Sponsor's protocol ID
- AA031009
- Other IDs
- R01AA031009
- Status last verified
- May 2025
- First submitted
- 24 Jan 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared in the NIAAA Data Archive
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Alcohol Use in Young Adult Couples
- ClinicalTrials.gov ID
- NCT06822257
- Acronym / sponsor ID
- AA031009
- Conditions
- Alcohol Consumption, Alcohol Drinking, Alcohol Intoxication
- Keywords
- alcohol administration, couples
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 504 participants (estimated)
- Lead sponsor
- Carnegie Mellon UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 12 Feb 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.
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.
Detailed description
This study investigates alcohol consumption in romantic relationships. Couples will be recruited to participate in a laboratory-based alcohol administration session, during which they will consume either a moderate dose of alcohol or a non-alcoholic beverage. Following beverage consumption, couples will complete questionnaires and tasks.
The study employs a multi-method approach to assess alcohol in couples, including self-reports and behavioral tasks, both inside and outside of the lab (e.g., using ecological momentary assessment). Additionally, participants' drinking patterns and relationship factors will be tracked over time, with follow-up assessments conducted at 6-months and 12 months post-laboratory session.
The findings from this research will provide insights into the role that alcohol consumption plays in close relationships and may inform interventions to support healthier drinking behaviors and relationship outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy couples who drink alcohol | Other | Drug: Alcohol beverage, Other: Non-alcohol beverageHealthy young adult couples who regularly drink alcohol |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- be between the ages of 21 and 30
- regularly consume alcohol
- own a smartphone
Key exclusion criteria (5 listed)
- 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
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 beveragemoderate dose of alcohol | Drug | Healthy couples who drink alcohol |
| Non-alcohol beverageNo alcohol given | Other | Healthy couples who drink alcohol |
Primary outcome
Social behaviors-observational
Time frame: During couple interactions in the lab for a total duration of 55 minutes.
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.
Emotions
Time frame: Immediately after the couple interactions in the lab referenced above.
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.
Social behaviors-self-report
Time frame: Immediately after the couple interactions in the lab referenced above.
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.
Real-world experiences
Time frame: The EMA protocol will be completed for 14 days post-lab session.
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).
Longer term alcohol problems
Time frame: Assessed longitudinally up to 12-months post-lab session.
Follow-up sessions will assess alcohol problems using DSM-5 alcohol use disorder criteria. Higher scores reflect more alcohol problems.
1 secondary outcome
Relationship functioning
Time frame: Assessed longitudinally up to 12-months post-lab session.
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 28 May 2025.
- Individual participant dataSharing planned: Yes. Data will be shared in the NIAAA Data Archive
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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 beverage and Non-alcohol beverage in people with Alcohol Consumption and Alcohol Drinking, run by Carnegie Mellon 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 5 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 28 May 2025. 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?
Contact Kasey G. Creswell, PhD (412-779-4931, kasey@andrew.cmu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social behaviors-observational (time frame: During couple interactions in the lab for a total duration of 55 minutes.). The study lists 5 primary outcomes in all. 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 28 May 2025.