Research on Translational Outcomes of Alcohol (Project RETRO)

NCT ID: NCT04742348

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2023-08-31

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.

Conditions

Alcohol Drinking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control, Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants who are randomized to placebo group will be provided with similar looking tablet(s) as the active drug.

Active Drug, Carbidopa + Levodopa

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

Group Type: EXPERIMENTAL

Carbidopa Levodopa

Intervention Type: DRUG

Participants who are randomized to active drug group will receive 1 dose of immediate release carbidopa-levodopa (50mg/500mg) .

Interventions

Carbidopa Levodopa

Participants who are randomized to active drug group will receive 1 dose of immediate release carbidopa-levodopa (50mg/500mg) .

Intervention Type: DRUG

Placebo

Participants who are randomized to placebo group will be provided with similar looking tablet(s) as the active drug.

Intervention Type: DRUG

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

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Brittney Hultgren

Acting Assistant Professor Department of Psychiatry and Behavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brittney Hultgren, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Other Identifiers

STUDY00009051

Identifier Type: -

Identifier Source: org_study_id