Decreasing the Temporal Window in Individuals With Alcohol Use Disorder

Alcohol Use Disorder Clinical Trial

— RP1B  

Official title:

Reinforcer Pathology 1B: Decreasing the Temporal Window

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04128761
• Other study ID #: #23-621
• Secondary ID: R01AA027381-01A1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 21, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: Virginia Polytechnic Institute and State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 112
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Behavioral:
• Scarcity Narrative
Participants are presented with a hypothetical scarcity narrative and asked to listen and consider the scenario.
• Neutral Narrative
Participants are presented with a hypothetical neutral narrative and asked to listen and consider the scenario.

Locations

Country	Name	City	State
United States	Fralin Biomedical Research Institute at VTC	Roanoke	Virginia

Sponsors (6)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University	Arizona State University, Carilion Clinic, McMaster University, National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)