Status:

COMPLETED

Satiety and Alcohol Challenge

Lead Sponsor:

University of North Carolina, Chapel Hill

Collaborating Sponsors:

Research Society on Alcohol

North Carolina Translational and Clinical Sciences Institute

Conditions:

Alcohol Drinking

Eligibility:

All Genders

21-45 years

Phase:

NA

Brief Summary

The goal of this pilot study is to identify the role of satiety on responses to alcohol drinking using human subject laboratory methods. Satiety will be manipulated over two sessions using a dietary s...

Detailed Description

Participants will receive a beverage containing either a dietary supplement (10g Fibersol®-2 mixed with water and aspartame sweetener for taste + 725mg decaffeinated green tea extract capsule) or a ca...

Eligibility Criteria

Inclusion

  • Age 21-45
  • Meeting NIAAA criteria for current at-risk drinking (i.e., \>7/14 drinks in one week for women/men, with at least one episodes of 4+/5+ drinks in the past 30 days)
  • Willingness to complete laboratory sessions involving blood draws and alcohol administration
  • Ability to communicate and read in English
  • Body mass index (BMI) of 21 - 30 kg/m\^2

Exclusion

  • Meets past-year criteria for severe Alcohol Use Disorder (\>7 of 11 symptoms endorsed) or AUDIT score of 20+
  • Meeting past-year criteria for a substance use disorder (with the exception of alcohol, tobacco or mild cannabis use disorder)
  • Current engagement in alcohol treatments, or currently engaged in intentional efforts to quit alcohol use
  • Current use of weight control medications
  • Lifetime diagnosis of severe mental illness (including schizophrenia and bipolar disorder)
  • History of suicide attempt, or psychiatric hospitalization in the last 6 months
  • History of diabetes
  • Medical conditions or medications for which alcohol is contraindicated
  • Pregnant, nursing, or trying to become pregnant
  • Plans to travel during the duration of study participation

Key Trial Info

Start Date :

September 3 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 9 2025

Estimated Enrollment :

64 Patients enrolled

Trial Details

Trial ID

NCT06576674

Start Date

September 3 2024

End Date

April 9 2025

Last Update

December 5 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of North Carolina

Chapel Hill, North Carolina, United States, 27599