Research on Translational Outcomes of Alcohol (Project RETRO)

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.

Study Overview

• Status: Withdrawn
• Conditions: Alcohol Drinking
• Intervention / Treatment: Drug: Placebo; Drug: Carbidopa Levodopa

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 Type: Interventional
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jessica Canning; Phone Number: 206-543-6974; Email: jrcannin@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 24 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 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.	Drug: Placebo; Participants who are randomized to placebo group will be provided with similar looking tablet(s) as the active drug.
EXPERIMENTAL: Active Drug, Carbidopa + Levodopa; Single dose of immediate release carbidopa-levodopa (50mg/500mg).	Drug: Carbidopa Levodopa; Participants who are randomized to active drug group will receive 1 dose of immediate release carbidopa-levodopa (50mg/500mg) .

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of Washington

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2023
• Primary Completion (ANTICIPATED): August 1, 2023
• Study Completion (ANTICIPATED): August 1, 2023

Study Registration Dates

• First Submitted: November 9, 2020
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (ACTUAL): February 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunologic Factors; Dopamine Agonists; Dopamine Agents; Adjuvants, Immunologic; Antiparkinson Agents; Anti-Dyskinesia Agents; Aromatic Amino Acid Decarboxylase Inhibitors; Levodopa; Carbidopa; Carbidopa, levodopa drug combination
• Other Study ID Numbers: STUDY00009051

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes