- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04276779
Effects of Alcohol and Mood on Attention
Acute Use of Alcohol and Attentional Bias Towards Suicide: An Experimental Test of the Attention-Allocation Model
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
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Birmingham, Alabama, United States, 35233
- Caitlin Clevenger
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
|
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.
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.
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|
Experimental: Alcohol
|
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.
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.
|
|
Experimental: Negative Mood
|
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.
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.
|
|
Active Comparator: Positive Mood
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Suicide Stroop Task
Time Frame: 10 minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brief Hopelessness Measure (Brief-H-Neg)
Time Frame: 5 minutes
|
A brief, 2-item questionnaire that assesses state hopelessness will also be assessed. The items were rated on a scale of 1 to 5. The scale score was the sum of the two items. The total possible score for the scale (sum of the two items) ranged from 2 to 10. Higher values indicate a worse outcome. |
5 minutes
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- GRANT13018273
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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