Research on Translational Outcomes of Alcohol (Project RETRO)

University of Washington

Status and phase

Withdrawn

Phase 4

Conditions

Alcohol Drinking

Treatments

Drug: Carbidopa Levodopa

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04742348

STUDY00009051

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

21 to 24 years old

Volunteers

Accepts 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.