Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03890484 |
| Other study ID # |
STUDY00006279 |
| Secondary ID |
F31AA027471-01 |
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 25, 2020 |
| Est. completion date |
July 3, 2022 |
Study information
| Verified date |
March 2024 |
| Source |
University of Washington |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The present study will evaluate college students (N=100) from 2- and 4-year
colleges/universities between 21-24 years old to assess anxiety, affect, broad social motives
(BSM) and peer group influences on drinking and other risk-taking behaviors. This study will
employ two sound scientific methods for testing behavior during drinking events (i.e., lab
alcohol administration and daily diary) and use novel strategies to compare results of these
two methods in the same sample. Using an ad-lib drinking paradigm, students' risk-taking, as
measured by the Balloon Analogue Risk Task (BART), will be assessed when alone and during one
of two randomly assigned peer group conditions (close friends or new peers). Participants
will be allowed to freely drink (within safety limits) with their peer group prior to
completing the BART again. These same students will complete daily electronic diaries on four
weekends (Thursday - Sunday; total 24 assessments) regarding BSM, motives to drink, peers in
their social group, alcohol use and consequences, and if/how their social group changed
(e.g., few close friends to large party with many new peers) during the drinking event.
Competing hypotheses will be tested such that: 1) anxiety is expected to be a stronger
predictor of drinking behavior and greater differences in risk-taking in the new peer
condition than close friend condition or 2) BSM is expected to be a stronger predictor of
drinking behavior and greater differences in risk-taking in the close friend condition than
new peers condition. Results are expected to be replicated in the daily diary reports.
Further, this multimethod approach will allow us to evaluate how behavior assessed in the lab
predicts naturally occurring behaviors in an uncontrolled setting. For example, the
investigators will assess whether greater increases in self-reported risk-taking from
baseline to after entering peer groups in the bar lab setting will predict heavier drinking
on nights when most drinking companions are close friends reported during daily diary.
Description:
Participants (N=100) will be recruited through direct outreach to University of Washington
(UW) students via the UW Registrar's directory list, as well as community flyers distributed
at colleges in the local area, online advertisements, and word of mouth. Participants will
complete screening measures online. Eligible participants will be stratified on sex, age, and
past 30-day peak alcohol use and randomly assigned to one of two conditions: close friends
(N=50), where participants will recruit two of their existing friends, or new peers (N=50),
where participants will drink with two strangers. To ensure at least two eligible friends,
those in the close friend group will be asked to provide email and phone numbers of five to
seven close friends. Close friends will have to meet the same inclusion and exclusion
criteria as target participants and will go through the same procedures as target
participants during alcohol administration. For each pair of participants matched on the
three strata (age, sex, alcohol use), strangers in the new peer group will be matched to the
sex of the close friends of the other matched participant's group.
Participants will be asked not to travel to the bar together to ensure they are not exposed
to their peer group before entry to the bar, and must get to the lab without operating any
vehicle with wheels (e.g. car, bike). Upon arriving to the lab, all participants and peers
will review and sign the consent form, and provide a baseline breath alcohol content (BrAC)
reading. Female participants and friends will also be asked to take a urine pregnancy test.
Participants and friends will complete baseline measures and the Balloon Analogue Risk Task
(BART) individually prior to entry to the bar. Then they will be taught the procedures for
the daily diary portion of the study (see below). Participants will join their close friends
or new peers in the bar and be given 20 minutes to relax while the researcher prepares the
materials. After entering groups but prior to receiving alcohol, participants and peers will
complete pre-alcohol measures and the BART. They will then be allowed to order anything from
the bar menu for the following hour. Participants and close friends will be allowed to drink
freely within limits (BrAC = .12%), for safety. During ad-lib, estimated BAC levels based on
age, sex, and weight will be calculated prior to each drink served to ensure the safety of
consuming each drink without interrupting social interaction and making the participant's BAC
more salient by taking BrAC readings regularly. Participants or close friends whose BAC may
exceed .12% will only be served placebo beverages for the remainder of the hour. BrAC
readings will be taken at the end of ad-lib, every 10 minutes until peak BrAC is reached and
readings are descending, and every 30 minutes thereafter. After ad-lib, participants will
complete post-alcohol measures and the BART, then provided entertainment until they reach a
BAC below .03%. The full protocol will take approximately 2.5 hours. On average, alcohol
metabolizes at a rate of .015% per hour, so a participant who reaches .12% will be in the lab
on average 8.5 hours. Once sober, participants and friends will be taken home in a taxi or
ride share service (e.g. Uber, Lyft). Close friends will not complete the following daily
diary protocols.
Daily diary measures will start on the Thursday following each participant's alcohol
administration appointment and be collected for potential drinking events on Thursday,
Friday, and Saturday over the following four consecutive weeks. Each day, participants will
be notified of surveys by text message at 4 pm and the following morning at 11am (Friday,
Saturday, and Sunday) for a total of 24 assessments. Surveys will be available for 2 hours
and reminders sent via text 30 minutes before closing. Afternoon assessments take
approximately 5 minutes and measure BSM, motives to drink, motives to refrain from drinking,
evening plans, and what type of peers they plan to spend the evening with (e.g. close
friends, new peers, family, alone). For the daily diary, BSM items have been modified to
select experiences which may vary daily (e.g. "making social plans got me excited and
energized today) and drinking motives have been modified into a brief prospective measure
consistent with modifications used in other studies15. At morning assessments, participants
will retrospectively report amount of drinks and other substances consumed, time spent
drinking, and consequences experienced while drinking or currently (morning after drinking).
Participants will be asked how many times their social group changed during the event defined
as the majority of their drinking companions being of a different peer type than before. For
instance, a participant may be at a house party with primarily close friends, but someone
invites several people the participant does not know well and they are now drinking with
mostly new peers. For each peer group reported (up to five groups), participants will report
the following characteristics of the group: size (i.e. number of people they had direct
contact with), number of drinking companions of each peer type (e.g. close friends, new
peers, family), gender composition of the group (same-sex vs. mixed-sex), time spent with and
drinks consumed with each group. On non-drinking evenings, participants will report similar
information regarding their social groups and other activities. This survey will take
approximately 5-7 minutes.
