Social Facilitation of Alcohol Effects and Alcohol Misuse in Young Adults
PALS
Multi-Method Investigation of Social Facilitation of Alcohol Effects and Alcohol Misuse in Young Adults
2 other identifiers
interventional
200
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2025
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
October 2, 2024
CompletedFirst Posted
Study publicly available on registry
October 4, 2024
CompletedStudy Start
First participant enrolled
February 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2029
August 12, 2025
August 1, 2025
4.5 years
October 2, 2024
August 7, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
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".
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.
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\]).
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.
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 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 YAACQ will be completed daily for 28 days.
Past 30-day Alcohol Consequences during Follow-Up
Past 30-day alcohol consequences will be assessed at 6 and 12 months following the initial laboratory sessions.
Study Arms (1)
Laboratory alcohol administration with longitudinal follow-ups
EXPERIMENTALAll 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.
Interventions
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%).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Southern California
Los Angeles, California, 90032, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 2, 2024
First Posted
October 4, 2024
Study Start
February 20, 2025
Primary Completion (Estimated)
August 31, 2029
Study Completion (Estimated)
August 31, 2029
Last Updated
August 12, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- We will submit data on or before the NDA submission due dates (April 1 and October 1 each year of the award starting in 2025) in accordance with the applicable Data Sharing Terms and Conditions of award. We will perform QA/QC checks on data within 4 months after the submission due dates and address any issues identified by the NDA. Study data will be available to the research community in perpetuity. Additionally, upon acceptance of a manuscript for publication, we will submit to NIAAADA data used in that publication to allow future analysts to replicate and expand upon the results.
- Access Criteria
- All study data will be deidentified and thus will be made available as public use data to the research community via NIAAADA. Users of the public use data must register with the NIAAADA data archive and agree to the Terms of Use, which are designed to protect study participants by limiting data use to scientific research and aggregate statistical reporting, prohibiting attempts to identify study participants, and requiring immediate reporting of any disclosure of study participant identity.
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.