COMPLETED

Satiety and Alcohol Challenge

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 supplement (fiber+green tea) or a calorically matched placebo. Responses to an acute alcohol challenge are measured.

Official Title

Effect of a Dietary Supplement on Satiety and Acute Responses to Laboratory Alcohol Challenge

Quick Facts

Study Start:2024-09-03
Study Completion:2025-04-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06576674

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 21-45
  2. * 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)
  3. * Willingness to complete laboratory sessions involving blood draws and alcohol administration
  4. * Ability to communicate and read in English
  5. * Body mass index (BMI) of 21 - 30 kg/m\^2
  1. * Meets past-year criteria for severe Alcohol Use Disorder (\>7 of 11 symptoms endorsed) or AUDIT score of 20+
  2. * Meeting past-year criteria for a substance use disorder (with the exception of alcohol, tobacco or mild cannabis use disorder)
  3. * Current engagement in alcohol treatments, or currently engaged in intentional efforts to quit alcohol use
  4. * Current use of weight control medications
  5. * Lifetime diagnosis of severe mental illness (including schizophrenia and bipolar disorder)
  6. * History of suicide attempt, or psychiatric hospitalization in the last 6 months
  7. * History of diabetes
  8. * Medical conditions or medications for which alcohol is contraindicated
  9. * Pregnant, nursing, or trying to become pregnant
  10. * Plans to travel during the duration of study participation

Contacts and Locations

Principal Investigator

Jimikaye Courtney, PhD
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill

Study Locations (Sites)

University of North Carolina
Chapel Hill, North Carolina, 27599
United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

  • Jimikaye Courtney, PhD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-03
Study Completion Date2025-04-09

Study Record Updates

Study Start Date2024-09-03
Study Completion Date2025-04-09

Terms related to this study

Additional Relevant MeSH Terms

  • Alcohol Drinking