Effects of Alcohol and Mood on Attention

NCT04276779 | Terminated Results

• 1 other identifier: GRANT13018273
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Ideas

Outcome Measures

Primary Outcomes (1)

• Modified Suicide Stroop Task

  A computer-based task that assesses reaction time to naming colors of words presented sequentially. Words are suicide, depressive, positive, and neutral-related. Reaction times that are higher indicate that the content of the word interfered with naming the color (i.e., attentional bias). A score is computed that subtracts reaction time to neutral words from that to suicide words, creating a measure of suicide-related attentional bias. Minimum total score within sample: -113.00 Maximum total score within the sample: 145.92 Higher values indicate more attentional bias (worse outcome).

  10 minutes

Secondary Outcomes (1)

• Brief Hopelessness Measure (Brief-H-Neg)

  5 minutes

Study Arms (4)

Negative Mood

EXPERIMENTAL

Other: Alcohol administration; Behavioral: Negative mood induction

Placebo

PLACEBO COMPARATOR

Other: Placebo administration; Behavioral: Negative mood induction

Positive Mood

ACTIVE COMPARATOR

Other: Alcohol administration; Behavioral: Positive mood induction

Alcohol

EXPERIMENTAL

Other: Placebo administration; Behavioral: Positive mood induction

Interventions

Alcohol administration OTHER

Participants in the alcoholic beverage group will be provided a dose of 95% alcohol (0.99g/kg for males and 0.90 g/kg for females body weight) distributed in two equally spaced beverages (mixed with orange juice 1:5 ratio). This dose will produce a breath alcohol content ranging between .08-.10.

Negative Mood; Positive Mood

Placebo administration OTHER

Individuals in the placebo condition will receive orange juice with 4 ml of alcohol layered on top of the juice. Ethanol will be sprayed on the rims of the glasses.

Alcohol; Placebo

Positive mood induction BEHAVIORAL

Participants will be randomized to either positive mood induction procedure. Both conditions involve listening to music that reliably induces positive mood, while simultaneously reading self-referent statements that also induce either positive mood. This procedure lasts about 10 minutes and produces a transient mood state that passes by the end of the study.

Alcohol; Positive Mood

Negative mood induction BEHAVIORAL

Participants will be randomized to either negative mood induction procedure. Both conditions involve listening to music that reliably induces sad mood, while simultaneously reading self-referent statements that also induce either sad mood. This procedure lasts about 10 minutes and produces a transient mood state that passes by the end of the study.

Negative Mood; Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be between the ages of 21 and 65
• 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
• 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
• be able to read and write in English fluently.

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Caitlin Clevenger

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Limitations and Caveats

Please note that this study was terminated. Data collection ended prematurely due to the PI leaving the institution. Preliminary data are reported on the sample collected.

Results Point of Contact

• Title: Dr. Caitlin Clevenger
• Organization: University of Alabama at Birmingham

cwclev@uab.edu

205-934-7008

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 19, 2020
• Study Start: March 10, 2022
• Primary Completion: December 8, 2023
• Study Completion: December 8, 2023
• Last Updated: March 11, 2025
• Results First Posted: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)