Alcohol ConsumptionPALSNCT06627803
Social Facilitation of Alcohol Effects and Alcohol Misuse in Young Adults
A study testing Alcohol (Oral) in people with Alcohol Consumption and Alcohol Abuse/Dependence, run by University of Southern California at 1 site in United States.
Trial summary
The purpose of this study is to understand social contexts and alcohol use. We hope to learn how being around peers affects alcohol consumption in young adults. About 200 young adults who drink alcohol frequently will take part in the study. Read more about this study
- Who is it for?
- Ages 21 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Consumption, Alcohol Abuse/Dependence
- What is being tested?
- Alcohol (Oral)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2025to 31 Aug 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 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 21-28 years of age
- Drink regularly (1+ times/week) with a same-sex platonic friend that also meets eligibility and is willing to participate
- Regular alcohol use (3+ times/week) with at least one binge drinking episode (5+ drinks [male] or 4+ drinks [female] in about 2 hours) in the past month
- BMI of 18-30
- Own a smart device operating on the iOS or Android operating system
- Fluent in English
Who cannot join
- Pregnancy or breastfeeding or intent to get pregnant in the next 60 days (females)
- medical conditions counter-indicated for alcohol administration
- seeking treatment for alcohol use
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
University of Southern California
Los Angeles, California, 90032
Matt G Kirkpatrick, 323-442-8221, mgkirkpa@usc.edu
Matt G Kirkpatrick, PhD
About this study
Official title: Multi-Method Investigation of Social Facilitation of Alcohol Effects and Alcohol Misuse in Young Adults
The purpose of this study is to understand social contexts and alcohol use. We hope to learn how being around peers affects alcohol consumption in young adults. About 200 young adults who drink alcohol frequently will take part in the study. This research is being funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA).
Participation involves one in-person screening session with a same-sex platonic friend. Then participants will complete four in-person laboratory sessions where they will drink beverages containing alcohol or no alcohol. After completion of the laboratory sessions, participants will complete smartphone surveys for 28 days. Lastly, they will complete follow-up surveys 6 months and 12 months post-study enrollment.
- Conditions
- Alcohol Consumption, Alcohol Abuse/Dependence
- Being tested
- Alcohol (Oral)
- Medical subject headings
- Alcohol Drinking, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol (Oral)Drug
Participants will drink a beverage that will have alcohol or no alcohol. The amount of alcohol consumed will be similar to consuming around 3-4 drinks, with breath alcohol concentration peaking at or around the legal limit for driving (0.08%).
| Study group | Role | What they receive |
|---|---|---|
| Laboratory alcohol administration with longitudinal follow-ups | Experimental | All participants will be in this single arm, which consists on behavioral testing of alcohol administration in the lab, followed by longitudinal follow-ups using Ecological Momentary Assessment and surveys. Receives: Drug: Alcohol (Oral) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug Effect Questionnaire (DEQ)
The Drug Effects Questionnaire (DEQ), a 5-item visual analog questionnaire (0 to 100 mm; not at all to extremely), will be used to assess the extent to which participants experience the effects of the drug: "feel drug," "feel high," "like drug," "dislike drug," and "want more".
Measured: The DEQ will be assessed 30 minutes before alcohol administration, and again 30, 60, 90, 120, 180, and 240 minutes after alcohol administration during each session.
Biphasic Alcohol Effects Scale (BAES)
The Biphasic Alcohol Effects Scale (BAES) is a 14-item survey that instructs individuals to rate the extent to which drinking alcohol has produced related subjective effects (0=not at all to 10=extremely). This questionnaire has two subscales consisting of mean scores related to sedation and stimulation.
Measured: The BAES will be assessed 30 minutes before alcohol administration, and again 30, 60, 90, 120, 180, and 240 minutes after alcohol administration during each session.
Quantity of Alcohol Use during Ecological Momentary Assessment
Quantity of alcohol use will be the number of drinks reported each day during the Ecological Momentary Assessment period. Number of drinks reported will be recoded to create two binary variables alcohol use (alcohol use [1+ drinks], no alcohol [0]) and binge drinking (binge [female: 4+ drinks; male: 5+ drinks], no binge (female: <4 drinks; male<5 drinks]).
Measured: Quantity of Alcohol Use will be assessed daily for 28 days.
Past 30-day Alcohol Use during Follow-Up
Past 30-day alcohol use (including number of drinks and binge drinking) will be assessed using the timeline follow-back method.
Measured: Past 30-day alcohol use will be assessed 6 and 12 months after the initial laboratory sessions.
Secondary outcomes (3)
Positive and Negative Affect Schedule (PANAS)
The Positive and Negative Affect Schedule (PANAS) is a well-validated brief scale comprised of 20 items meas-uring positive affect (e.g., excited, inspired) and negative affect (e.g., upset, afraid) in the moment. Each item is rated on a five-point Likert Scale, ranging from 1 = Very Slightly or Not at all to 5 = Extremely).
Measured: The PANAS will be assessed 30 minutes before alcohol administration, and again 30, 60, 90, 120, 180, and 240 minutes after alcohol administration during each session.
Brief Young Adult Alcohol Consequences Questionnaire (YAACQ) during Ecological Momentary Assessment
The validated Brief Young Adult Alcohol Consequences Questionnaire (YAACQ) is a 24-item measure assessing negative alcohol-related consequences. Summary scores are the sum of all items.
Measured: The YAACQ will be completed daily for 28 days.
Past 30-day Alcohol Consequences during Follow-Up
Past 30-day alcohol consequences will be assessed using the validated Brief Young Adult Alcohol Consequences Questionnaire (YAACQ), a 24-item measure assessing negative alcohol-related consequences. Summary scores are the sum of all items.
Measured: Past 30-day alcohol consequences will be assessed at 6 and 12 months following the initial laboratory sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start20 Feb 2025
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Matthew Kirkpatrick, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627803
- Sponsor's protocol ID
- UP-24-00590
- Other IDs
- 1R01AA031240-01A1
- Acronym
- PALS
- Status last verified
- Aug 2025
- First submitted
- 2 Oct 2024
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Per NOT-AA-22-003, this study will submit and share de-identified demographic and primary and secondary outcome data with NIAAA Data Archive (NIAAADA), a data repository housed within the NIMH Data Archive (NDA). Datasets will be findable and identifiable through a persistent study digital object identifier (DOI) generated by NDA.
Publications
Pang RD, Schuler LA, Fairbairn CE, Huh J, Kirkpatrick MG. Social facilitation as a risk factor for alcohol misuse in young adults: study protocol for a prospective alcohol administration study. BMC Psychol. 2026 May 28;14(1):1105. doi: 10.1186/s40359-026-04880-0.
PubMed 42210315
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Method Investigation of Social Facilitation of Alcohol Effects and Alcohol Misuse in Young Adults
- ClinicalTrials.gov ID
- NCT06627803
- Acronym / sponsor ID
- PALS / UP-24-00590
- Conditions
- Alcohol Consumption, Alcohol Abuse/Dependence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 4 Oct 2024 (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.
The purpose of this study is to understand social contexts and alcohol use. We hope to learn how being around peers affects alcohol consumption in young adults. About 200 young adults who drink alcohol frequently will take part in the study. This research is being funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA).
Participation involves one in-person screening session with a same-sex platonic friend. Then participants will complete four in-person laboratory sessions where they will drink beverages containing alcohol or no alcohol. After completion of the laboratory sessions, participants will complete smartphone surveys for 28 days. Lastly, they will complete follow-up surveys 6 months and 12 months post-study enrollment.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laboratory alcohol administration with longitudinal follow-ups | Experimental | Drug: Alcohol (Oral)All participants will be in this single arm, which consists on behavioral testing of alcohol administration in the lab, followed by longitudinal follow-ups using Ecological Momentary Assessment and surveys. |
Who may qualify
- Ages
- 21 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 21-28 years of age
- Drink regularly (1+ times/week) with a same-sex platonic friend that also meets eligibility and is willing to participate
- Regular alcohol use (3+ times/week) with at least one binge drinking episode (5+ drinks [male] or 4+ drinks [female] in about 2 hours) in the past month
- BMI of 18-30
- Own a smart device operating on the iOS or Android operating system
Key exclusion criteria (3 listed)
- Pregnancy or breastfeeding or intent to get pregnant in the next 60 days (females)
- medical conditions counter-indicated for alcohol administration
- seeking treatment for alcohol use
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 (Oral)Participants will drink a beverage that will have alcohol or no alcohol. The amount of alcohol consumed will be similar to consuming around 3-4 drinks, with breath alcohol concentration peaking at or around the legal limit for driving (0.08%). | Drug | Laboratory alcohol administration with longitudinal follow-ups |
Primary outcome
Drug Effect Questionnaire (DEQ)
Time frame: The DEQ will be assessed 30 minutes before alcohol administration, and again 30, 60, 90, 120, 180, and 240 minutes after alcohol administration during each session.
The Drug Effects Questionnaire (DEQ), a 5-item visual analog questionnaire (0 to 100 mm; not at all to extremely), will be used to assess the extent to which participants experience the effects of the drug: "feel drug," "feel high," "like drug," "dislike drug," and "want more".
Biphasic Alcohol Effects Scale (BAES)
Time frame: The BAES will be assessed 30 minutes before alcohol administration, and again 30, 60, 90, 120, 180, and 240 minutes after alcohol administration during each session.
The Biphasic Alcohol Effects Scale (BAES) is a 14-item survey that instructs individuals to rate the extent to which drinking alcohol has produced related subjective effects (0=not at all to 10=extremely). This questionnaire has two subscales consisting of mean scores related to sedation and stimulation.
Quantity of Alcohol Use during Ecological Momentary Assessment
Time frame: Quantity of Alcohol Use will be assessed daily for 28 days.
Quantity of alcohol use will be the number of drinks reported each day during the Ecological Momentary Assessment period. Number of drinks reported will be recoded to create two binary variables alcohol use (alcohol use [1+ drinks], no alcohol [0]) and binge drinking (binge [female: 4+ drinks; male: 5+ drinks], no binge (female: <4 drinks; male<5 drinks]).
Past 30-day Alcohol Use during Follow-Up
Time frame: Past 30-day alcohol use will be assessed 6 and 12 months after the initial laboratory sessions.
Past 30-day alcohol use (including number of drinks and binge drinking) will be assessed using the timeline follow-back method.
3 secondary outcomes
Positive and Negative Affect Schedule (PANAS)
Time frame: The PANAS will be assessed 30 minutes before alcohol administration, and again 30, 60, 90, 120, 180, and 240 minutes after alcohol administration during each session.
Brief Young Adult Alcohol Consequences Questionnaire (YAACQ) during Ecological Momentary Assessment
Time frame: The YAACQ will be completed daily for 28 days.
Past 30-day Alcohol Consequences during Follow-Up
Time frame: Past 30-day alcohol consequences will be assessed at 6 and 12 months following the initial laboratory sessions.
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 12 Aug 2025.
- Derived from this study: PubMed 42210315Pang RD, Schuler LA, Fairbairn CE, Huh J, Kirkpatrick MG. Social facilitation as a risk factor for alcohol misuse in young adults: study protocol for a prospective alcohol administration study. BMC Psychol. 2026 May 28;14(1):1105. doi: 10.1186/s40359-026-04880-0.
- Individual participant dataSharing planned: Yes. Per NOT-AA-22-003, this study will submit and share de-identified demographic and primary and secondary outcome data with NIAAA Data Archive (NIAAADA), a data repository housed within the NIMH Data Archive (NDA). Datasets will be findable and identifiable through a persistent study digital object identifier (DOI) generated by NDA.
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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 (Oral) in people with Alcohol Consumption and Alcohol Abuse/Dependence, run by University of Southern California 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 6 inclusion and 3 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 12 Aug 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 Matt G Kirkpatrick, PhD (323-442-8221, mgkirkpa@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug Effect Questionnaire (DEQ) (time frame: The DEQ will be assessed 30 minutes before alcohol administration, and again 30, 60, 90, 120, 180, and 240 minutes after alcohol administration during each session.). The study lists 4 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 NCT06627803, which also lists 1 linked publication.
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 12 Aug 2025.