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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
Virginia Polytechnic Institute and State University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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.

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    Decreasing the Temporal Window in Individuals With Alcohol Use Disorder

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