Research on Translational Outcomes of Alcohol (Project RETRO)

NCT04742348 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: STUDY00009051
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alcohol Drinking

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Alcohol craving

  At the end of alcohol administration. Alcohol administration is 1 hour.

Study Arms (2)

Control, Placebo

PLACEBO COMPARATOR

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

Active Drug, Carbidopa + Levodopa

EXPERIMENTAL

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

Drug: Carbidopa Levodopa

Interventions

Carbidopa Levodopa DRUG

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

Active Drug, Carbidopa + Levodopa

Placebo DRUG

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

Control, Placebo

Eligibility Criteria

• Age: 21 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead

MeSH Terms

Conditions

Alcohol Drinking

Interventions

carbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Officials

• Brittney Hultgren, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Acting Assistant Professor Department of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: February 8, 2021
• Study Start: February 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: February 13, 2023

Record last verified: 2023-02