Observing the natural history of alcohol use and its effects

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather comprehensive data on individuals with varying levels of alcohol use, including those with alcohol use disorders, problematic drinkers, social drinkers, and healthy volunteers. Participants will undergo physical exams, answer health-related questions, and provide biological samples for analysis. The goal is to create a standardized dataset that includes clinical, behavioral, biochemical, and genetic information to better understand the impact of alcohol on health and inform future research. The study will categorize participants into treatment-seeking and non-treatment-seeking groups based on their desire for treatment.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Nancy Diazgranados, M.D. — National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Study coordinator: Beth A Lee, R.N.
• Email: beth.lee@nih.gov
• Phone: (301) 451-6964

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.