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Withdrawn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

About this trial
This is an interventional treatment trial for Alcohol Drinking
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.
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
NCT ID
NCT04742348
First Posted
November 9, 2020
Last Updated
February 9, 2023
Sponsor
University of Washington
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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