RECRUITING

Neural and Hormonal Influences on Sex Differences in Risk for AUD

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 sex gap in alcohol consumption is closing rapidly, due to alarming increases among women. From 2002-2013, Alcohol Use Disorder (AUD) increased 84% for women, compared to 35% for men. As such, there is an urgent need to determine the factors underlying sex differences in risk for AUD. Current addiction models propose three domains that drive problematic alcohol use and serve as candidate sex-specific risk factors: executive function, negative emotionality, and incentive salience. Data suggest that poor inhibitory control, a key component of executive function, is a stronger risk factor for women than for men. Moreover, there is have preliminary evidence that female drinkers show less engagement of neural inhibitory circuitry, and that this sex difference is influenced by estradiol. However, the degree to which hormonally-moderated sex differences in executive function extend to the negative emotionality and incentive salience domains, and how these sex differences influence current and future drinking is unknown. The goal of this study is to identify the mechanisms underlying sex-specific risk for AUD, and ultimately to help develop sex-specific prevention and treatment efforts. The overall objective of this trial is to determine the neural and hormonal factors contributing to sex-specific risk for AUD in three addiction domains: inhibitory control (executive function), negative emotionality, and alcohol cue reactivity (incentive salience).

Official Title

Sex Differences in Risk for Alcohol Use Disorder: Neural and Hormonal Influences

Quick Facts

Study Start:2021-05-11
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04929288

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 26 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * consume 4/5 drinks per week
  2. * fluent in English
  3. * high school education
  4. * right-handed
  5. * regular menstrual cycles (women)
  1. * serious medical problems
  2. * body weight \<110 or \>210 lbs
  3. * current medical or psychiatric conditions requiring medication for which alcohol is contraindicated
  4. * substance use disorder other than alcohol
  5. * current or recent history of inpatient/intensive treatment for addictive behaviors
  6. * pregnant, nursing, on hormonal contraception
  7. * contraindications for fMRI
  8. * smoking \> 5 cigarettes per day

Contacts and Locations

Study Contact

Jessica Weafer, PhD
CONTACT
614-366-0163
Jessica.Weafer@osumc.edu

Principal Investigator

Jessica Weafer, PhD
PRINCIPAL_INVESTIGATOR
Ohio State University

Study Locations (Sites)

The Ohio State University
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Jessica Weafer

  • Jessica Weafer, PhD, PRINCIPAL_INVESTIGATOR, Ohio State University

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 Date2021-05-11
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2021-05-11
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

  • sex
  • inhibitory control
  • risk factor
  • hormone
  • fMRI
  • menstrual cycle

Additional Relevant MeSH Terms

  • Alcohol Use Disorder