Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Alcoholism
Type
Observational
Design
Observational Model: Case-ControlTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 100 years
Gender
Both males and females

Description

This study represents the natural history protocol for NIAAA with the main objectives of providing assessment, clinical care, evaluation, characterization and screening. The specific goals of this protocol are the following: To provide clinical care, including but not limited to medically assisted w...

This study represents the natural history protocol for NIAAA with the main objectives of providing assessment, clinical care, evaluation, characterization and screening. The specific goals of this protocol are the following: To provide clinical care, including but not limited to medically assisted withdrawal from alcohol ( detoxification ), as well as standard behavioral and/or pharmacological therapies where indicated to those who wish to receive treatment for alcohol use disorders (AUD) and related clinical conditions. To gather characterization measures for individuals wishing to participate in this protocol and in future NIH protocols (for which this protocol serves as the screening protocol), including a standardized set of clinical, behavioral, biochemical and structural MRI-based phenotypic assessments, as well as whole genome genotypes To screen and evaluate individuals wishing to participate in NIH clinical protocols (both those providing treatment and those that do not provide treatment for AUD) for which the present protocol serves as the screening platform. Participants may be individuals with no current or past AUD, as well as individuals who meet current or past DSM criteria for AUD. Healthy volunteers and other volunteers will also be enrolled in this protocol. Finally, this protocol may also serve for training purposes, as it may provide opportunities for training of fellows and other staff members of the NIAAA Clinical Programs. ANA Substudy objective: To obtain assessments built around three neuroscience domains, incentive salience, negative emotionality, and executive function, related to addiction for purposes of identifying neuroscience-based, clinically-relevant subtypes of alcohol use disorder and alcohol use patterns We will collect information including such items as psychiatric diagnoses and symptoms, biomarkers of liver and other organ damage, quantitative alcohol use history, other substance use, and family history of alcoholism. Using this information, investigators will be able to clinically manage any disorders in need of clinical attention, and determine whether subjects are eligible for any NIH research studies (for which this protocol serves as the screening platform) based on results of screening evaluations and the participants interest in receiving treatment for AUD. We will also acquire whole genome data, with which investigators will be able to examine the relationship between genetic variation and alcohol-related phenotypes. Consenting for this protocol will be a two-step process. The first consent (named Clinical Management Consent) will allow Investigators to assess the acute needs and provide appropriate clinical care. The second consent (named Screening and Research Consent) will allow Investigators to conduct screening and research data collection and analysis.The substudy will have its own consent, the Addictions Neuroclinical Assessment (ANA) consent.

Tracking Information

NCT #
NCT02231840
Collaborators
Not Provided
Investigators
Principal Investigator: Nancy Diazgranados, M.D. National Institute on Alcohol Abuse and Alcoholism (NIAAA)