Status:

RECRUITING

NIAAA Natural History Protocol

Lead Sponsor:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Conditions:

Alcohol Use Disorder

Eligibility:

All Genders

18-100 years

Brief Summary

Background: \- About 17 million adults had an alcohol use disorder in 2012. Researchers want to follow people that have alcohol problems and want treatment, as well as those who do not want treatment...

Detailed Description

Study Description: This study represents the natural history protocol for NIAAA with the main objectives of providing deep phenotyping of patients across the alcohol use spectrum. This includes Alcoh...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • As this is a natural history protocol of alcohol use as a continuum, in order to be eligible to participate in this study, an individual must meet the following criterion:
  • Age \>=18 years of age
  • Willingness to complete the study including genetic and MRI tests.
  • We will assign participants to one of two groups in this study:
  • Treatment-seeking individuals (Patients that want to stop alcohol use and will require medical management to achieve sobriety) and
  • Non-treatment-seeking participants (Patients or healthy volunteers who want to continue their current alcohol use).
  • All participants are initially phone-screened for eligibility and their desire for treatment of AUD (or lack of it) will determine their group allocation. Their self-report of health status, pregnancy, legal status, and willingness to complete the study including the genetics and MRI test will be assessed in the phone screen and determine eligibility.
  • EXCLUSION CRITERIA:
  • This is a natural history protocol of alcohol use as a continuum. Potential participants are pre-screened on the phone and, based on the information provided on the phone, the following categories are excluded because they are not suitable study participants for this protocol:
  • Individuals \< 18 years of age
  • Prisoners
  • Pregnant candidates
  • Candidates having a severe medical or mental health disorder that would impair participation in the study
  • All participants are initially phone-screened for eligibility: age, legal status, pregnancy, and severe medical conditions will be assessed using information reported in the phone screen to determine eligibility for the study.

Exclusion

    Key Trial Info

    Start Date :

    January 21 2015

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 31 2044

    Estimated Enrollment :

    7500 Patients enrolled

    Trial Details

    Trial ID

    NCT02231840

    Start Date

    January 21 2015

    End Date

    December 31 2044

    Last Update

    December 8 2025

    Active Locations (1)

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    National Institutes of Health Clinical Center

    Bethesda, Maryland, United States, 20892