Research on Translational Outcomes of Alcohol (Project RETRO)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Research on Translational Outcomes of Alcohol (Project RETRO)

Conditions
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Alcohol Drinking

Intervention / Treatment
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* Drug: Carbidopa Levodopa
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control, Placebo<br>Similar looking tablet(s) to active drug will be administered in a single dose to those who are randomly assigned to this group. | Drug: Placebo<br>* Participants who are randomized to placebo group will be provided with similar looking tablet(s) as the active drug.<br>|
| Experimental: Active Drug, Carbidopa + Levodopa<br>Single dose of immediate release carbidopa-levodopa (50mg/500mg). | Drug: Carbidopa Levodopa<br>* Participants who are randomized to active drug group will receive 1 dose of immediate release carbidopa-levodopa (50mg/500mg) .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol Consumption | Number of alcoholic drinks consumed | 1 hour | 
| Alcohol Craving | Amount of alcohol craving as assessed by the Alcohol Urge Questionnaire by Bohn, Krahn & Staehler (1995) | 30 minutes in to alcohol administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol craving | Amount of alcohol craving as assessed by the Alcohol Urge Questionnaire by Bohn, Krahn & Staehler (1995) | At the end of alcohol administration. Alcohol administration is 1 hour. |