Social Facilitation of Alcohol Effects and Alcohol Misuse in Young Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-28
SponsorUniversity of Southern California
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Alcohol (Oral)
DrugParticipants 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%).
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Laboratory alcohol administration with longitudinal follow-upsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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".
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.2
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.
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.3
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\]).
Time frame
Quantity of Alcohol Use will be assessed daily for 28 days.4
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.
Time frame
Past 30-day alcohol use will be assessed 6 and 12 months after the initial laboratory sessions.Secondary outcomes
1
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).
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.2
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.
Time frame
The YAACQ will be completed daily for 28 days.3
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.
Time frame
Past 30-day alcohol consequences will be assessed at 6 and 12 months following the initial laboratory sessions.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Southern California
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov