Decreasing the Temporal Window in Individuals With Alcohol Use Disorder (RP1B)

Reinforcer Pathology 1B: Decreasing the Temporal Window

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, studies investigating the effects of scarcity on alcohol demand discounting rate have been limited. The purpose of Aim 1b is to examine effects of decreasing the temporal window and its concomitant effects on alcohol valuation (demand, and craving) and delay discounting.

Study Overview

• Status: Enrolling by invitation
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Behavioral: Scarcity Narrative; Behavioral: Neutral Narrative

Detailed Description

Participants will be randomly assigned to experimental or control groups, balanced by discounting rates and sex. We plan to have 112 participants complete the study, based on our power analysis. Participants will complete two online sessions. During the first session, they will complete the baseline assessments. During the second session, they will complete the same assessments after being exposed to the scarcity or control narratives (both in audio format).

The assessment will include delay discounting and demand tasks, and measures of alcohol craving. 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.

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Devin Tomlinson; Phone Number: 5405262015; Email: dtomlinson@vt.edu
• Study Contact Backup: Name: Kirstin Gatchalian; Phone Number: 5405262071; Email: kmgatch@vtc.vt.edu

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Fralin Biomedical Research Institute at VTC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Exclusion Criteria:

• having a current unmanaged psychotic disorder
• reporting current pregnancy or lactation
• having dementia

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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) and Session 2 (S2; occurs approximately 2-3 days after S1)
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) and Session 2 (S2; occurs approximately 2-3 days after S1)
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) and Session 2 (S2; occurs approximately 2-3 days after S1)

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) and Session 2 (S2; occurs approximately 2-3 days after S1)
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) and Session 2 (S2; occurs approximately 2-3 days after S1)

Collaborators and Investigators

• Sponsor: Virginia Polytechnic Institute and State University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); McMaster University; Carilion Clinic; University of Kentucky; Arizona State University
• Investigators: Principal Investigator: Warren K Bickel, PhD, Fralin Biomedical Research Institute at VTC; Principal Investigator: Stephen M LaConte, PhD, Fralin Biomedical Research Institute at VTC

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 15, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Alcohol Craving; Delay Discounting; Behavioral Economic Demand; Scarcity Narrative
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism
• Other Study ID Numbers: #23-621; R01AA027381-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Investigators will adhere to all NIH requirements regarding data sharing. Participant data collected in this project will be de-identified and made available on a shared secured data repository. We will also share the analysis results. As part of this process, all investigators will be required to agree to the following conditions: 1) will adhere to the reporting responsibilities; 2) will not redistribute the data beyond the requesting individual and named collaborators; 3) will give appropriate acknowledgement; 4) will not use the data for commercial purposes; and 5) will obtain appropriate ethical approvals.

Results from research conducted will be shared and disseminated, including: regular project meetings, annual meetings, symposia, workshops, and/or conferences for related groups. Manuscripts will be written and submitted for publication in peer-reviewed journals/conferences, following the NIH Public Access Policy guidelines. All necessary ethical approvals will be obtained.

• IPD Sharing Time Frame: Data will be made available upon request after dissemination of results.
• IPD Sharing Access Criteria: Data requests will be reviewed by the principal investigator and data will be shared with the expectation of acknowledgment of funding source and primary study team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No