Research on Translational Outcomes of Alcohol (Project RETRO)

Phase 4

Withdrawn

• Conditions: Alcohol Drinking
• Interventions: Drug: Placebo; Drug: Carbidopa Levodopa

• Registration Number: NCT04742348
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2021-02-03
• Study First Posted: 2021-02-08
• Status Verified: 2023-02
• Study Start: 2023-02
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-13
• Primary Completion: 2023-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control, Placebo	Placebo	Similar looking tablet(s) to active drug will be administered in a single dose to those who are randomly assigned to this group.
Active Drug, Carbidopa + Levodopa	Carbidopa Levodopa	Single dose of immediate release carbidopa-levodopa (50mg/500mg).

Primary Outcome Measures

Name	Time	Method
Alcohol Consumption	1 hour	Number of alcoholic drinks consumed
Alcohol Craving	30 minutes in to alcohol administration	Amount of alcohol craving as assessed by the Alcohol Urge Questionnaire by Bohn, Krahn \& Staehler (1995)

Secondary Outcome Measures

Name	Time	Method
Alcohol craving	At the end of alcohol administration. Alcohol administration is 1 hour.	Amount of alcohol craving as assessed by the Alcohol Urge Questionnaire by Bohn, Krahn \& Staehler (1995)