Decreasing the Temporal Window in Individuals With Alcohol Use Disorder

Study Overview
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Brief Summary
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In the absence of sufficient monetary resources, individuals must attend to immediate, minimum needs (e.g., food, shelter). This constricts one's temporal window and engenders neglect of the future. In observational studies, scarcity is associated with higher rates of delay discounting. Additionally, socioeconomic status is inversely associated with alcohol use disorder and related problems. Experimentally, scarcity shortens attention, impedes cognitive function, and increases delay discounting in multiple populations. Moreover, scarcity increases demand for fast foods in the obese and increases craving for alcohol in problem drinkers. These data suggest that economic scarcity worsens both components of reinforcer pathology (delay discounting and alcohol overvaluation), thus increasing vulnerability to alcohol use disorder. However, the effects of scarcity on alcohol self-administration and on neural networks related to discounting rate have yet to be examined. The purpose of Aim 1b is to examine effects of decreasing the temporal window and its concomitant effects on alcohol valuation (self-administration, demand, and craving). Economic scarcity is hypothesized to increase both alcohol valuation and neural activation of areas associated with the impulsive decision system (e.g., the ventral striatum).

Detailed Description
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Participants will be randomly assigned to experimental or control groups, stratified by AUDIT scores, SES, age, and sex. Based on 8 years of experience recruiting alcohol users into studies of comparable length and complexity, 82% of consented participants are anticipated to be eligible (i.e., randomized) and 89% of those individuals will complete Aim 1b. Thus, to achieve a final sample size of 64, 88 participants will be consented. Participants will complete: a baseline assessment (S1), an alcohol self-administration session (S2/S3), and an fMRI session (S2/S3). The alcohol self-administration session and the fMRI session will be completed in a counterbalanced order and in the presence of assigned narratives (i.e., scarcity or neutral). Participants will be assigned to the scarcity or neutral narrative groups. Participants in both groups will be instructed to read the assigned narrative, consider it for 15 seconds and vividly imagine that this narrative applies to them. Next, participants will complete the primary and secondary outcome measures (e.g., in the presence of these narratives complete assessments of delay discounting and alcohol valuation and then proceed to the alcohol self-administration or fMRI session, as counterbalanced). Participants will also complete assessments of their stress and mood response to the narrative intervention, using the Stress Appraisal Measure (SAM) and PANAS for two purposes. That is, 1) to monitor participant safety, 2) to measure the mediating ability of affect on changes in the temporal window. During all assessments of S2 and S3, text and/or audio prompts of the narratives will be presented.

Official Title
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Reinforcer Pathology 1B: Decreasing the Temporal Window

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Behavioral: Scarcity Narrative
* Behavioral: Neutral Narrative


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: High-risk or harmful drinking (AUDIT>15) 21 years of age or older Desire to quit or cut down on their drinking, but do not have proximate plans to enroll in treatment for AUD during the study period Report as one of their top three preferred drinks a beverage appropriate for the alcohol self-administration task. Exclusion Criteria: Moderate to severe DSM-5 criteria for substance-use disorders other than alcohol or nicotine Current diagnosis of any psychotic disorder History of seizure disorders or traumatic brain injury Contraindication for participation in the self-administration or MRI sessions Current pregnancy, lactation, or absence of evidence-based contraception.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scarcity Narrative<br>Participants assigned to the scarcity group will be asked to read and consider a hypothetical narrative about a sudden loss of resources. | Behavioral: Scarcity Narrative<br>* Participants are presented with a hypothetical scarcity narrative and asked to read and consider the scenario.<br>|
| Sham Comparator: Neutral Narrative<br>Participants assigned to the neutral group will be asked to read and consider a hypothetical narrative about a neutral change in resources. | Behavioral: Neutral Narrative<br>* Participants are presented with a hypothetical neutral narrative and asked to read and consider the scenario.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Delay Discounting | Delay-discounting tasks provide a measure of the temporal window and examine the devaluation of awards as a function of the delay to the receipt. These computerized assessments provide participants with hypothetical choices between smaller amounts of a reward available immediately and a larger amount of a reward after a range of delays (1 day-25 years). Discounting rates will be measured using adjusting amount delay discounting and minute delay discounting tasks. Change in discounting rates will be compared within-subjects between Session 1 and Session 2 AND Session 1 and Session 3. Change scores will be compared between groups (arms). | At the first session (S1; baseline measures; Day 1), Session 2 (S2; occurs up to 7 days post S1), and Session 3 (S3; occurs up to 7 days post S2). | 
| Change in Alcohol Demand | Intensity and elasticity of alcohol demand will be determined from an alcohol demand curve via an Alcohol Purchase Task (APT). Change in alcohol demand will be compared within-subjects between Session 1 and Session 2 AND Session 1 and Session 3. Change scores will be compared between groups (arms). | At the first session (S1; baseline measures; Day 1), Session 2 (S2; occurs up to 7 days post S1), and Session 3 (S3; occurs up to 7 days post S2). | 
| Change in Alcohol Craving | A brief questionnaire (the Alcohol Urges Questionnaire) will be used assess alcohol craving. The Alcohol Urges Questionnaire is an 8-item survey which produces scores between 8-56, where higher scores indicate greater craving. Change in alcohol craving will be compared within-subjects between Session 1 and Session 2 AND Session 1 and Session 3. Change scores will be compared between groups (arms). | At the first session (S1; baseline measures; Day 1), Session 2 (S2; occurs up to 7 days post S1), and Session 3 (S3; occurs up to 7 days post S2). | 
| In-Laboratory Alcohol Consumption | The number of alcoholic beverages purchased/consumed during the self-administration session will be recorded. The average number of drinks will be compared between groups. | Self-Administration session will occur at either Session 2 or Session 3 based on counterbalance assignment. Session 2 occurs up to 7 days post Session 1 and Session 3 occurs up to 7 days post Session 2. | 
| Neural activation during fMRI delay discounting task | Brain maps will be compared between groups. | fMRI session will occur at either Session 2 or Session 3 based on counterbalance assignment. Session 2 occurs up to 7 days post Session 1 and Session 3 occurs up to 7 days post Session 2. | 
| Neural activation during fMRI alcohol purchase task | Brain maps will be compared between groups. | fMRI session will occur at either Session 2 or Session 3 based on counterbalance assignment. Session 2 occurs up to 7 days post Session 1 and Session 3 occurs up to 7 days post Session 2. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Stress Appraisal Measure | The Stress Appraisal Measure will be used to measure acute stress induced by the intervention. This measure is a 28-item survey which produces scores between 28-140, where higher scores indicate greater stress. Change in stress will be compared within-subjects between Session 1 and Session 2 AND Session 1 and Session 3. Change scores will be compared between groups (arms). | At the first session (S1; baseline measures; Day 1), Session 2 (S2; occurs up to 7 days post S1), and Session 3 (S3; occurs up to 7 days post S2). | 
| Change in Positive and Negative Affect Schedule | The Positive and Negative Affect Schedule (PANAS) will be used to measure mood induced by the intervention. This 20-item survey measures 10 positive and 10 negative affective states. The positive affect score ranges from 10-50, with higher scores representing greater positive affect. The negative affect score ranges from 10-50, with higher scores representing greater negative affect. Change in PANAS will be compared within-subjects between Session 1 and Session 2 AND Session 1 and Session 3. Change scores will be compared between groups (arms). | At the first session (S1; baseline measures; Day 1), Session 2 (S2; occurs up to 7 days post S1), and Session 3 (S3; occurs up to 7 days post S2). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delay Discounting, Behavioral Economic Demand, Scarcity Narrative, Self-Administration, Functional MRI, Alcohol Craving