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Impulsivity Domains and Subjective Response

Primary Purpose

Alcohol Use Disorder

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Placebo
Alcohol
Sponsored by
Jessica Weafer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcohol Use Disorder focused on measuring Addiction, Alcohol, Young adult, Impulsivity, Prevention, Subjective response

Eligibility Criteria

21 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 21-25 years old Report drinking to an estimated BAC > .08% at least once in the past 30 days based on responses on the Timeline Followback (TLFB) Report drinking at least twice weekly in the past 30 days based on responses on the TLFB Fluency in English Exclusion Criteria: Any serious medical problems (e.g., liver disease, cardiac abnormality, pancreatitis, diabetes, neurological problems, and gastrointestinal disorders) Body weight < 110 or > 210 pounds Axis I psychiatric disorders including substance use disorder other than mild or moderate alcohol or mild cannabis use disorder Current alcohol withdrawal or history of medically-assisted detoxification Two positive breath alcohol concentration (BrAC) readings (i.e., > 0.00%) at an in-person screening appointment or experimental session Positive urine screen for illegal drugs other than cannabis Currently seeking or past-12-month history of inpatient or intensive treatment for addictive behaviors Current psychotropic medication use or receipt of a prescription for these medications in the past 30 days Psychosis or other psychiatric disability Pregnancy, nursing or lack of reliable birth control use for women Report smoking > 5 cigarettes per day (to avoid acute nicotine effects or withdrawal during experimental sessions)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Alcohol, Then Placebo, then Free-access session

    Placebo, Then Alcohol, then Free-access session

    Arm Description

    participants will complete two intravenous administration sessions in the lab during which they will receive alcohol then placebo (saline), followed by a third lab session in which they will have free-access to self-administer alcohol (up to 120mg% BrAC) and placebo intravenously for 60 min

    participants will complete two intravenous administration sessions in the lab during which they will receive placebo (saline) then alcohol, followed by a third lab session in which they will have free-access to self-administer alcohol (up to 120mg% BrAC) and placebo intravenously for 60 min

    Outcomes

    Primary Outcome Measures

    Lab Subjective Response to Alcohol (SR)
    Participants provide subjective ratings of stimulation and sedation using the Brief Biphasic Alcohol Effects Scale (scores from 0 to 10 where a higher number means more stimulation/sedation).
    Ecological Momentary Assessment (EMA) Subjective Response to Alcohol (SR)
    Participants provide subjective ratings of stimulation and sedation using the Brief Biphasic Alcohol Effects Scale (scores from 0 to 10 where a higher number means more stimulation/sedation) using the EMA app.
    Change in Breath Alcohol Concentration (BrAC)
    Highest BrAC in mg% taken by breathalyzer during the free-access period
    Number of alcohol drink units self administered
    participants can self-administer alcohol infusions by pushing 1 of 2 buttons to receive an alcohol or water "drink" unit. Each alcohol "drink" targets a 7.5mg% increase in BrAC over 2.5 min. The water "drink" is an equal volume of saline.
    Number of drinks per day
    Participants will report the number of drinks they consume each day via EMA app added to their phone.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 19, 2023
    Last Updated
    October 23, 2023
    Sponsor
    Jessica Weafer
    Collaborators
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05929677
    Brief Title
    Impulsivity Domains and Subjective Response
    Official Title
    Linking Impulsivity Domains and Subjective Response to Alcohol in Young Adults Using Lab and Daily Assessment Methods
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    September 1, 2027 (Anticipated)
    Study Completion Date
    September 1, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Jessica Weafer
    Collaborators
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Findings from this project will determine the relationship between two vulnerability factors for Alcohol Use Disorder (AUD) in young adults: impulsivity and subjective response to alcohol. The results will identify badly needed, novel targets for prevention and treatment efforts to simultaneously reduce impulsivity and subjective responses in at-risk young adults.
    Detailed Description
    Young adult alcohol misuse is an urgent, growing public health crisis, as young adults have the highest alcohol use disorder rates of any age group with rates increasing in young women. Interventions for this population are hampered by small effects, few options and lack of tailoring to salient risk factors. A recent review in Addiction argued that research informing interventions fails to account for the complexity of relationships among factors contributing to young adult alcohol misuse. These needs will be addressed by examining relationships between two cardinal etiologic risk factors: impulsivity and subjective response to alcohol (SR). Despite theoretical and biological links between them, little is known about relations between the two risk factors, or how associations between them may promote young adult alcohol misuse longitudinally and on a momentary or daily basis. Prior theory and evidence linking impulsivity and positive, rewarding alcohol effects have been primarily learning and expectancy based. Here, based on exciting preliminary results, the researchers posit an inherent, biological link between impulsivity and high-risk SR (elevated stimulation and dampened sedation). This research is nascent with multiple gaps in knowledge. These gaps will be addressed by examining impulsivity pre-drinking, SR and alcohol use in a lab setting and via seven 10-day daily assessment periods over 2 years using ecological momentary assessment (EMA) (N=250, 50% female). Using self-report and both lab and mobile tasks, the investigators will characterize 3 unique, established impulsivity domains: poor inhibitory control, delay discounting and negative urgency. SR will be assessed at successive breath alcohol levels using precision intravenous (IV) methods in the lab, followed by opportunity to self-administer more IV alcohol. SR will also be measured at roughly comparable, estimated blood alcohol levels via daily EMA methods. This design enables testing of SR early in a drinking event as a predictor of in-lab and daily alcohol use, along with alcohol use and consequences over time, plus SR's potential role as a mediator of impulsivity/alcohol relations. Recent findings indicate daily changes in impulsivity predict subsequent drinking and consequences. These types of changes are challenging to capture with lab methods only. Daily measures also enable modeling of both person-level individual differences and daily, within-subject effects. However, there are no published studies relating daily impulsivity and SR measures. In this study, investigators will: 1) determine relations between lab-based impulsivity and SR; 2) determine relations between daily impulsivity and SR; and 3) relate impulsivity and SR to alcohol misuse longitudinally. Researchers hypothesize impulsivity will relate to heightened stimulation and less sedation following alcohol and that SR will partially mediate relations between impulsivity and alcohol misuse. Evidence of links between specific impulsivity domains and SR longitudinally and on a momentary/daily basis will point to specific intervention targets to ameliorate two critical vulnerability factors for young adult alcohol misuse. Thus, investigators will: 1) identify mechanisms of alcohol action and 2) facilitate prevention and treatment research: two NIAAA priority areas. Findings from this project will determine the relationship between two vulnerability factors for Alcohol Use Disorder (AUD) in young adults: impulsivity and subjective response to alcohol. The results will identify badly needed, novel targets for prevention and treatment efforts to simultaneously reduce impulsivity and subjective responses in at-risk young adults. As such, the project is directly relevant to NIAAA's mission to identify mechanisms of alcohol action and facilitate prevention and treatment research.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Use Disorder
    Keywords
    Addiction, Alcohol, Young adult, Impulsivity, Prevention, Subjective response

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Early Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    250 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Alcohol, Then Placebo, then Free-access session
    Arm Type
    Experimental
    Arm Description
    participants will complete two intravenous administration sessions in the lab during which they will receive alcohol then placebo (saline), followed by a third lab session in which they will have free-access to self-administer alcohol (up to 120mg% BrAC) and placebo intravenously for 60 min
    Arm Title
    Placebo, Then Alcohol, then Free-access session
    Arm Type
    Experimental
    Arm Description
    participants will complete two intravenous administration sessions in the lab during which they will receive placebo (saline) then alcohol, followed by a third lab session in which they will have free-access to self-administer alcohol (up to 120mg% BrAC) and placebo intravenously for 60 min
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Saline
    Intervention Description
    Participants receive placebo (saline) intravenously. They will also have the opportunity to self-administer saline during the 60-minute free-access IV self-administration period in session 3.
    Intervention Type
    Drug
    Intervention Name(s)
    Alcohol
    Intervention Description
    Participants receive alcohol intravenously, clamped at BrACs of 20mg%, 40mg%, and 60mg%. They will also have the opportunity to self-administer alcohol (up to 120mg% BrAC) during the 60-minute free-access IV self-administration period in session 3.
    Primary Outcome Measure Information:
    Title
    Lab Subjective Response to Alcohol (SR)
    Description
    Participants provide subjective ratings of stimulation and sedation using the Brief Biphasic Alcohol Effects Scale (scores from 0 to 10 where a higher number means more stimulation/sedation).
    Time Frame
    70 minutes
    Title
    Ecological Momentary Assessment (EMA) Subjective Response to Alcohol (SR)
    Description
    Participants provide subjective ratings of stimulation and sedation using the Brief Biphasic Alcohol Effects Scale (scores from 0 to 10 where a higher number means more stimulation/sedation) using the EMA app.
    Time Frame
    10 days
    Title
    Change in Breath Alcohol Concentration (BrAC)
    Description
    Highest BrAC in mg% taken by breathalyzer during the free-access period
    Time Frame
    60 minutes
    Title
    Number of alcohol drink units self administered
    Description
    participants can self-administer alcohol infusions by pushing 1 of 2 buttons to receive an alcohol or water "drink" unit. Each alcohol "drink" targets a 7.5mg% increase in BrAC over 2.5 min. The water "drink" is an equal volume of saline.
    Time Frame
    60 minutes
    Title
    Number of drinks per day
    Description
    Participants will report the number of drinks they consume each day via EMA app added to their phone.
    Time Frame
    10 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 21-25 years old Report drinking to an estimated BAC > .08% at least once in the past 30 days based on responses on the Timeline Followback (TLFB) Report drinking at least twice weekly in the past 30 days based on responses on the TLFB Fluency in English Exclusion Criteria: Any serious medical problems (e.g., liver disease, cardiac abnormality, pancreatitis, diabetes, neurological problems, and gastrointestinal disorders) Body weight < 110 or > 210 pounds Axis I psychiatric disorders including substance use disorder other than mild or moderate alcohol or mild cannabis use disorder Current alcohol withdrawal or history of medically-assisted detoxification Two positive breath alcohol concentration (BrAC) readings (i.e., > 0.00%) at an in-person screening appointment or experimental session Positive urine screen for illegal drugs other than cannabis Currently seeking or past-12-month history of inpatient or intensive treatment for addictive behaviors Current psychotropic medication use or receipt of a prescription for these medications in the past 30 days Psychosis or other psychiatric disability Pregnancy, nursing or lack of reliable birth control use for women Report smoking > 5 cigarettes per day (to avoid acute nicotine effects or withdrawal during experimental sessions)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jessica Weafer, PhD
    Phone
    859-257-5451
    Email
    jweafer@uky.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jessica Weafer, PhD
    Organizational Affiliation
    University of Kentucky
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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