Decreasing the Temporal Window in Individuals With Alcohol Use Disorder (RP1B)
Primary Purpose
Alcohol Use Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Scarcity Narrative
Neutral Narrative
Sponsored by
About this trial
This is an interventional basic science trial for Alcohol Use Disorder focused on measuring Delay Discounting, Behavioral Economic Demand, Scarcity Narrative, Self-Administration, Functional MRI, Alcohol Craving
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Scarcity Narrative
Neutral Narrative
Arm Description
Participants assigned to the scarcity group will be asked to read and consider a hypothetical narrative about a sudden loss of resources.
Participants assigned to the neutral group will be asked to read and consider a hypothetical narrative about a neutral change in resources.
Outcomes
Primary Outcome Measures
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).
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).
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).
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.
Neural activation during fMRI delay discounting task
Brain maps will be compared between groups.
Neural activation during fMRI alcohol purchase task
Brain maps will be compared between groups.
Secondary Outcome Measures
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).
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).
Full Information
NCT ID
NCT04128761
First Posted
October 10, 2019
Last Updated
June 14, 2023
Sponsor
Virginia Polytechnic Institute and State University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), McMaster University, Arizona State University, Carilion Clinic, University of Kentucky
1. Study Identification
Unique Protocol Identification Number
NCT04128761
Brief Title
Decreasing the Temporal Window in Individuals With Alcohol Use Disorder
Acronym
RP1B
Official Title
Reinforcer Pathology 1B: Decreasing the Temporal Window
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Polytechnic Institute and State University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), McMaster University, Arizona State University, Carilion Clinic, University of Kentucky
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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, 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
Keywords
Delay Discounting, Behavioral Economic Demand, Scarcity Narrative, Self-Administration, Functional MRI, Alcohol Craving
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Scarcity Narrative
Arm Type
Experimental
Arm Description
Participants assigned to the scarcity group will be asked to read and consider a hypothetical narrative about a sudden loss of resources.
Arm Title
Neutral Narrative
Arm Type
Sham Comparator
Arm Description
Participants assigned to the neutral group will be asked to read and consider a hypothetical narrative about a neutral change in resources.
Intervention Type
Behavioral
Intervention Name(s)
Scarcity Narrative
Intervention Description
Participants are presented with a hypothetical scarcity narrative and asked to read and consider the scenario.
Intervention Type
Behavioral
Intervention Name(s)
Neutral Narrative
Intervention Description
Participants are presented with a hypothetical neutral narrative and asked to read and consider the scenario.
Primary Outcome Measure Information:
Title
Change in Delay Discounting
Description
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).
Time Frame
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).
Title
Change in Alcohol Demand
Description
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).
Time Frame
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).
Title
Change in Alcohol Craving
Description
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).
Time Frame
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).
Title
In-Laboratory Alcohol Consumption
Description
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.
Time Frame
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.
Title
Neural activation during fMRI delay discounting task
Description
Brain maps will be compared between groups.
Time Frame
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.
Title
Neural activation during fMRI alcohol purchase task
Description
Brain maps will be compared between groups.
Time Frame
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 Measure Information:
Title
Change in Stress Appraisal Measure
Description
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).
Time Frame
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).
Title
Change in Positive and Negative Affect Schedule
Description
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).
Time Frame
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Devin Tomlinson
Phone
5405262015
Email
dtomlinson@vt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kirstin Gatchalian
Phone
5405262071
Email
kmgatch@vtc.vt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Warren K Bickel, PhD
Organizational Affiliation
Fralin Biomedical Research Institute at VTC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen M LaConte, PhD
Organizational Affiliation
Fralin Biomedical Research Institute at VTC
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Decreasing the Temporal Window in Individuals With Alcohol Use Disorder
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