Observing the natural history of alcohol use and its effects
NIAAA Natural History Protocol
This study is trying to learn how different levels of alcohol use affect people's health by collecting information from a variety of drinkers, including those who want help and those who don't.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 7500 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT02231840 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older, both those seeking treatment for alcohol use and those who are not.
Not a fit: Patients who are pregnant or imprisoned will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for individuals with alcohol use disorders.
How similar studies have performed: Other studies have shown success in using similar observational approaches to understand alcohol use and its effects, making this a promising area of research.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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 this trial is running
Bethesda, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.