Clinical trial

Neurobiological Factors Underlying Sex Differences in Risk for Alcohol Abuse

Name

50301

Description

This study will determine the neural and hormonal mechanisms underlying sex differences in sensitivity to the disinhibiting effects of alcohol in heavy drinkers.

Trial arms

Trial start

2019-11-01

Estimated PCD

2023-05-24

Trial end

2023-05-24

Status

Completed

Treatment

Alcohol

Alcohol will be administered by IV infusion (60mg%). Brain activation during response inhibition (BARI) will be assessed using fMRI during performance of the stop signal task.

Arms:

Females, Males

Other names:

ethyl alcohol

Size

Primary endpoint

Change in Brain Activation During Response Inhibition (BARI)

4 weeks

Eligibility criteria

Inclusion Criteria: * heavy drinking * Alcohol Use Disorder Identification Test score above 7 * right-handed * BMI between 19 and 26 * high school education * fluent in English * women must have regular menstrual cycles * not using hormonal contraceptives Exclusion Criteria: * drug use disorder (SCID, DSM-5), other than nicotine or caffeine * meets withdrawal criteria * history of physical or psychiatric disease * contraindication for fMRI * pregnant or breastfeeding * smoking more than 5 cigarettes per day

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 22, 'type': 'ACTUAL'}}

Updated at

2023-08-28

1 organization

1 product

1 indication

Organization

Mark Fillmore

Product

Alcohol

Indication

Alcohol abuse