NIAAA Natural History Protocol

Launched by NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM (NIAAA) · Sep 3, 2014

Keywords

ClinConnect Summary

The NIAAA Natural History Protocol is a clinical trial designed to learn more about alcohol use disorder, which affects about 17 million adults in the U.S. The study aims to follow both people who are struggling with alcohol and want help, as well as those who are not seeking treatment, along with healthy volunteers. Researchers want to gather information about how genes and body processes relate to alcohol use. This knowledge could help improve prevention and treatment strategies for alcohol problems.

To participate in this study, you need to be at least 18 years old, not pregnant or in prison, and willing to complete various assessments, including health questions, blood tests, and possibly a brain scan. Participants will be divided into two groups: those seeking treatment for alcohol use and those who are not. If you qualify, you can expect a physical exam, health questionnaires, and follow-up calls after your involvement to discuss your health and drinking habits. If you join the study, it could help researchers better understand alcohol use and contribute to developing better treatment options in the future.

Gender

ALL

Eligibility 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.