Clinical trial NCT04276779: Effects of Alcohol and Mood on Attention
Official title: Acute Use of Alcohol and Attentional Bias Towards Suicide: An Experimental Test of the Attention-Allocation Model
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Suicidal Ideas
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

This study was ended prior to the planned study end date due to PI leaving the insitution. Thus only the results for the preliminary data are reported.

Eligibility criteria: Inclusion criteria:

1. be between the ages of 21 and 65
2. have consumed an average of at least five or more (four or more for females) standard alcoholic drinks per occasion once over the past year
3. have self-administered a quantity of alcohol that is equal to or greater than the dose that will be administered in the lab on at least three occasions in the past year
4. be able to read and write in English fluently.

Exclusion criteria:

1. active psychosis, suicidal ideation/intent, or mania; currently receiving psychiatric treatment; have received psychiatric treatment in past year or currently experiencing significant psychiatric distress
2. in treatment or recovery from drug or alcohol use disorders or abstaining from alcohol
3. any suicide attempt history
4. pregnant/breast-feeding or immediate plans to become pregnant
5. any chronic health problems or medications that would preclude the use of alcohol
6. (to minimize adverse reactions to alcohol/inappropriate alcohol dose) \< 6 feet tall and over 230 lbs., or \> 6 feet tall and over 250 lbs.
7. color-blind or sight-impaired
8. knowing someone who has participated in this study.

Primary outcomes:
measure: Modified Suicide Stroop Task
timeFrame: 10 minutes
Secondary outcomes:
measure: Brief Hopelessness Measure (Brief-H-Neg)
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Caitlin Clevenger
state: Alabama
Study officials:
References: