Suicidal IdeasNCT04276779
Effects of Alcohol and Mood on Attention
A study testing Alcohol administration, Positive mood induction and Negative mood induction in people with Suicidal Ideas, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicidal Ideas
- What is being tested?
- Alcohol administration, Positive mood induction and Negative mood induction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2022to 8 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Use of Alcohol and Attentional Bias Towards Suicide: An Experimental Test of the Attention-Allocation Model
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.
Read the 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.
- Conditions
- Suicidal Ideas
- Being tested
- Alcohol administration, Placebo administration, Positive mood induction, Negative mood induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol administrationOther
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.
Placebo administrationOther
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.
Positive mood inductionBehavioural
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.
Negative mood inductionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Negative Mood | Experimental | Not described Receives: Other: Alcohol administration; Behavioral: Negative mood induction |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo administration; Behavioral: Negative mood induction |
| Positive Mood | Active comparator | Not described Receives: Other: Alcohol administration; Behavioral: Positive mood induction |
| Alcohol | Experimental | Not described Receives: Other: Placebo administration; Behavioral: Positive mood induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10 minutes
Secondary outcomes (1)
Brief Hopelessness Measure (Brief-H-Neg)
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start10 Mar 2022
- Primary completion8 Dec 2023
- Study completion8 Dec 2023
Why it stopped: The study was stopped due to the PI leaving the institution. The grant was ended early.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Suicidal IdeasStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caitlin Wolford Clevenger, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276779
- Sponsor's protocol ID
- GRANT13018273
- Status last verified
- Mar 2025
- First submitted
- 14 Feb 2020
- Last updated
- 11 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Use of Alcohol and Attentional Bias Towards Suicide: An Experimental Test of the Attention-Allocation Model
- ClinicalTrials.gov ID
- NCT04276779
- Acronym / sponsor ID
- GRANT13018273
- Conditions
- Suicidal Ideas
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped due to the PI leaving the institution. The grant was ended early.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 8 Dec 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 19 Feb 2020 (actual)
- Results
- Posted 11 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol administrationParticipants 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. | Other | Negative Mood, Positive Mood |
| Placebo administrationIndividuals 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. | Other | Alcohol, Placebo |
| Positive mood inductionParticipants 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. | Behavioural | Alcohol, Positive Mood |
| Negative mood inductionParticipants 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. | Behavioural | Negative Mood, Placebo |
Primary outcome
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).
1 secondary outcome
Brief Hopelessness Measure (Brief-H-Neg)
Time frame: 5 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol administration, Positive mood induction and Negative mood induction in people with Suicidal Ideas, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Suicide Stroop Task (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.