Clinical trial
Research on Translational Outcomes of Alcohol (Project RETRO)
Name
STUDY00009051
Description
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.
Trial arms
Trial start
2023-02-01
Estimated PCD
2023-08-01
Trial end
2023-08-01
Status
Withdrawn
Phase
Early phase I
Treatment
Carbidopa Levodopa
Participants who are randomized to active drug group will receive 1 dose of immediate release carbidopa-levodopa (50mg/500mg) .
Arms:
Active Drug, Carbidopa + Levodopa
Placebo
Participants who are randomized to placebo group will be provided with similar looking tablet(s) as the active drug.
Arms:
Control, Placebo
Primary endpoint
Alcohol Consumption
1 hour
Alcohol Craving
30 minutes in to alcohol administration
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:
* 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2023-02-13
1 organization
1 product
1 drug
1 indication
Organization
University of WashingtonProduct
Carbidopa LevodopaIndication
Alcohol consumptionDrug
Varlilumab