Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04276779 |
| Other study ID # |
GRANT13018273 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 10, 2022 |
| Est. completion date |
December 8, 2023 |
Study information
| Verified date |
December 2023 |
| Source |
University of Alabama at Birmingham |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Acute use of alcohol is related to increased risk for suicide. However, our understanding of
this problem is hindered by the lack of experimental tests of conditions underlying the
alcohol use-suicide relationship. The attention allocation model (AAM) proposes that alcohol
intoxication limits individuals' focus to salient cues in their environment. Thus, acute use
of alcohol (AUA) during negative mood states may cause people to focus their attention
towards suicide-related cues in their environment, thus increasing their risk for suicide
while intoxicated. The proposed pilot study tests the AAM by exploring the combined effects
of AUA, mood, and alcohol expectancies on attentional bias towards suicide-related cues. The
proposed study will explore the combined impact of AUA and negative mood on attentional bias
towards suicide in a sample of community adults. The investigators will further explore
whether individual differences in alcohol expectancies influence these associations. The
investigators will conduct a 2 by 2 (alcohol/placebo by negative mood/positive mood),
between-subjects experiment involving alcohol administration, a well-established mood
induction paradigm, and a performance-based dependent measure of attention towards
suicide-related cues. The investigators expect that individuals in the negative mood-alcohol
condition to show the greatest suicide-related attentional bias. The investigators expect
that alcohol expectancies related to suicide will strengthen this association, and that
positive mood alcohol expectancies will weaken this association. This pilot study will
provide an initial test of the feasibility of this project and the hypotheses. This study
will form the basis for a larger scale study able to test the effects.
Description:
This is a pilot study designed to explore the combined effects of acute use of alcohol, mood,
and alcohol expectancies on attentional bias towards suicide. Community adults (n = 120) will
be recruited from the University of Alabama at Birmingham campus and greater Birmingham area
through distribution of flyers and posts to social media sites (i.e., Facebook and
Craigslist). The investigators are recruiting individuals who are ages 21-65, generally
healthy, without current psychiatric disorders, distress, or suicidal ideation, and able to
safely consume alcohol. Interested individuals will telephone our research lab, and an
initial telephone screening will take place to exclude ineligible participants. Eligible
participants will attend an initial study session (lasting about one hour), where informed
consent will be obtained,eligibility criteria will be more thoroughly assessed, and baseline
measures (e.g., alcohol expectancies) will be completed. Participants who remain eligible
will be scheduled for a second session, lasting between 3-10 hours (depending on condition),
and will be randomly assigned (individually) to an alcohol condition (alcohol-placebo) and a
mood condition (negative-positive mood). Participants in the alcohol condition will be
administered alcoholic beverages that will raise their breath alcohol content to .08.
Participants in the placebo condition will be told they are receiving alcohol but will
receive a nonalcoholic beverage that smells and tastes like alcohol. Participants will
participate in a mood induction procedure that involves listening to music and reading
statements about the self that are designed to induce a temporary mood state (positive or
negative). Immediately following the mood induction, participants will rate their mood using
a rating scale and then will complete a computerized assessment of their attentional bias
towards suicide-related words (i.e., the Suicide Stroop). This measure involves naming colors
of words that vary in meaning (neutral, happy, depressed, and suicide-related words).
Participants' response times to name the color of suicide-related words are compared to
response times to name neutral words, creating a score of suicide-related attentional bias.
Following completion of this task, individuals in the placebo condition will complete a
post-study interview, where their experiences and the effectiveness of deception will be
assessed. Participants will be debriefed and the deception and reasons for it will be
revealed. Participants' suicide risk will be assessed and they will be allowed to leave if
risk is low (which the investigators anticipate will be the case for all participants).
Individuals in the alcoholic beverage condition will complete the same post-study procedures
but after their breath alcohol content lowers to .03. While awaiting their breath alcohol
content to lower, these participants will be provided with a comfortable area to rest and
watch or read entertainment. They will be provided a full meal and nonalcoholic beverages and
will be encouraged to drink some water. Participants' driver's license or government-issued
ID will be held by study personnel until their breath alcohol content lowers to .03.
Participants will not be allowed to leave until their breath alcohol content lowers to .03,
and they pass a field sobriety test. All participants will be provided with cab fare for a
safe ride home. Safety checks will be performed for all participants the evening of, day
following, and week following the study appointment.
