Research on Translational Outcomes of Alcohol (Project RETRO)

Alcohol Drinking Clinical Trial

Official title:

Research on Translational Outcomes of Alcohol (Project RETRO)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04742348
• Other study ID #: STUDY00009051
• Status: Withdrawn
• Phase: Phase 4
• Start date: February 2023
• Est. completion date: August 2023

Study information

• Verified date: February 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking

Intervention

Drug:
• Carbidopa Levodopa
Participants who are randomized to active drug group will receive 1 dose of immediate release carbidopa-levodopa (50mg/500mg) .
• Placebo
Participants who are randomized to placebo group will be provided with similar looking tablet(s) as the active drug.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol Consumption	Number of alcoholic drinks consumed	1 hour
Primary	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	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.