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Research on Translational Outcomes of Alcohol (Project RETRO)

Primary Purpose

Alcohol Drinking

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Carbidopa Levodopa
Placebo
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Drinking

Eligibility Criteria

21 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Enrolled in 2- or 4-year college program
  • Currently living in the Seattle Metropolitan area
  • Have at least two or more episodes of heavy episodic drinking (4/5 or more drinks in a 2 hours for women/men) in the past 30 days.

Exclusion Criteria:

  • Exclusion criteria include:
  • past-month severe alcohol or other substance use disorders,
  • mood or anxiety disorder
  • suicidal ideation
  • risk of psychotic disorders
  • excessive alcohol use reaching a Blood Alcohol Level greater than .30%
  • history of serious medical conditions, regular use of prescription psychotropic or pain medication
  • history of negative reactions to alcohol
  • history of treatment for alcohol use disorder
  • pregnancy or nursing.
  • use of non-selective monoamine oxidase inhibitors in the past 2 weeks.
  • narrow-angle glaucoma
  • undiagnosed skin lesions,
  • have a history of melanoma, cardiac issues or peptic ulcer.
  • Currently taking or prescribed any form of levodopa or D2 agonists, D2 antagonists, isoniazid, methylphenidate, bupropion, Viagra, or phosphodiesterase inhibitors.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Control, Placebo

    Active Drug, Carbidopa + Levodopa

    Arm Description

    Similar looking tablet(s) to active drug will be administered in a single dose to those who are randomly assigned to this group.

    Single dose of immediate release carbidopa-levodopa (50mg/500mg).

    Outcomes

    Primary Outcome Measures

    Alcohol Consumption
    Number of alcoholic drinks consumed
    Alcohol Craving
    Amount of alcohol craving as assessed by the Alcohol Urge Questionnaire by Bohn, Krahn & Staehler (1995)

    Secondary Outcome Measures

    Alcohol craving
    Amount of alcohol craving as assessed by the Alcohol Urge Questionnaire by Bohn, Krahn & Staehler (1995)

    Full Information

    First Posted
    November 9, 2020
    Last Updated
    February 9, 2023
    Sponsor
    University of Washington
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04742348
    Brief Title
    Research on Translational Outcomes of Alcohol (Project RETRO)
    Official Title
    Research on Translational Outcomes of Alcohol (Project RETRO)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    COVID-19 and expiration of funding
    Study Start Date
    February 2023 (Anticipated)
    Primary Completion Date
    August 2023 (Anticipated)
    Study Completion Date
    August 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Washington

    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
    The primary aim of the current study is to assess the effect of a single dose of carbidopa-levodopa on ad libitum alcohol consumption and alcohol craving in young adults with a history of binge drinking.
    Detailed Description
    This is a small (N = 42) 2-arm, double-blind, randomized controlled pilot study to assess the effect of a single dose of immediate release carbidopa-levodopa (50mg/500mg) to acutely reduce alcohol consumption and craving in college students with a history of heavy episodic drinking. Participants will be between 21-24 years old from 2- and 4- year colleges in the Seattle Metropolitan area. Interested students will contact the study line and provide verbal consent to be sent a link to an online screening survey. Eligible participants will be scheduled to come in for the ad libitum alcohol administration. Participants will receive either the carbidopa-levodopa or a placebo and complete the alcohol administration protocol.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Drinking

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control, Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Similar looking tablet(s) to active drug will be administered in a single dose to those who are randomly assigned to this group.
    Arm Title
    Active Drug, Carbidopa + Levodopa
    Arm Type
    Experimental
    Arm Description
    Single dose of immediate release carbidopa-levodopa (50mg/500mg).
    Intervention Type
    Drug
    Intervention Name(s)
    Carbidopa Levodopa
    Intervention Description
    Participants who are randomized to active drug group will receive 1 dose of immediate release carbidopa-levodopa (50mg/500mg) .
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Participants who are randomized to placebo group will be provided with similar looking tablet(s) as the active drug.
    Primary Outcome Measure Information:
    Title
    Alcohol Consumption
    Description
    Number of alcoholic drinks consumed
    Time Frame
    1 hour
    Title
    Alcohol Craving
    Description
    Amount of alcohol craving as assessed by the Alcohol Urge Questionnaire by Bohn, Krahn & Staehler (1995)
    Time Frame
    30 minutes in to alcohol administration
    Secondary Outcome Measure Information:
    Title
    Alcohol craving
    Description
    Amount of alcohol craving as assessed by the Alcohol Urge Questionnaire by Bohn, Krahn & Staehler (1995)
    Time Frame
    At the end of alcohol administration. Alcohol administration is 1 hour.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    24 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Enrolled in 2- or 4-year college program Currently living in the Seattle Metropolitan area Have at least two or more episodes of heavy episodic drinking (4/5 or more drinks in a 2 hours for women/men) in the past 30 days. Exclusion Criteria: Exclusion criteria include: past-month severe alcohol or other substance use disorders, mood or anxiety disorder suicidal ideation risk of psychotic disorders excessive alcohol use reaching a Blood Alcohol Level greater than .30% history of serious medical conditions, regular use of prescription psychotropic or pain medication history of negative reactions to alcohol history of treatment for alcohol use disorder pregnancy or nursing. use of non-selective monoamine oxidase inhibitors in the past 2 weeks. narrow-angle glaucoma undiagnosed skin lesions, have a history of melanoma, cardiac issues or peptic ulcer. Currently taking or prescribed any form of levodopa or D2 agonists, D2 antagonists, isoniazid, methylphenidate, bupropion, Viagra, or phosphodiesterase inhibitors.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Brittney Hultgren, PhD
    Organizational Affiliation
    University of Washington
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Research on Translational Outcomes of Alcohol (Project RETRO)

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