NIAAA Natural History Protocol
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|ClinicalTrials.gov Identifier: NCT02231840|
Recruitment Status : Recruiting
First Posted : September 4, 2014
Last Update Posted : March 30, 2023
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- 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 and healthy volunteers. They also want to gather information on people with and without alcohol problems, including information on genes and biological processes in the body.. This will help them better understand, prevent, and treat alcohol problems.
-To look at a broad range of traits in people who are healthy people and people with alcohol problems. To study them for potential eligibility for other research protocols conducted at the NIH Clinical Center.
- Adults age 18 and older.
- Not being pregnant or imprisoned.
- Participants will have a physical exam. They will answer questions about their health and alcohol and drug use. They will have an electrocardiogram to check their heart. They will have blood, urine, and breath alcohol tests.
- Participants without alcohol problems, or who have them but do not want treatment, can sign the second consent for screening and research.
- Participants that have alcohol problems and want treatment will be treated at the NIH Clinical Center. They will be offered to sign the second consent at a later time.
- Participants may join an inpatient treatment and detox program. It could last up to 6 weeks. Or they may join an outpatient program. Some may do both.
- After discharge, participants may be called and asked questions about their drinking and health.
- If participants sign the second consent, they:
- will complete paper- and computer-based questionnaires.
- will give blood samples.
- may have a brain scan using magnetic resonance imaging. They will lie on a table that slides in and out of a cylinder that takes pictures. The machine makes loud noises. They will get earplugs.
|Condition or disease|
|Alcohol Use Disorder|
|Study Type :||Observational|
|Estimated Enrollment :||7500 participants|
|Official Title:||NIAAA Natural History Protocol|
|Actual Study Start Date :||January 21, 2015|
|Estimated Primary Completion Date :||December 31, 2044|
|Estimated Study Completion Date :||December 31, 2044|
Not treatment-seeking participants
Individuals who meet current or past DSM 5 criteria for AUD but are not seeking treatment. Healthy volunteers and other volunteers.
Individuals who meet current DSM 5 criteria for AUD and are seeking treatment for it.
- Obtain phenotypic assessments [ Time Frame: CROSS SECTIONAL ]To gather characterization measures for individuals wishing to participate in this protocol, including a standardized set of clinical, behavioral, biochemical, and structural MRI-based phenotypic assessments, as well as whole genome genotypes
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 100 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
- 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.
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02231840
|Contact: Megan S Carraco||(301) email@example.com|
|Contact: Nancy Diazgranados, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Nancy Diazgranados, M.D.||National Institute on Alcohol Abuse and Alcoholism (NIAAA)|
|Responsible Party:||National Institute on Alcohol Abuse and Alcoholism (NIAAA)|
|Other Study ID Numbers:||
|First Posted:||September 4, 2014 Key Record Dates|
|Last Update Posted:||March 30, 2023|
|Last Verified:||February 28, 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||.All IDP, identifiable specimens and data from this protocol will be shared with other NIH protocols for future research, so that data collected under different studies from a single individual may be combined for analysis after IRB approval and informed consent (or waiver of consent) for the use of the data for the research is in place. Data will be shared from two locations: @@@1) The NIH Clinical Center Clinical Research Information System (CRIS) system, where we routinely store clinical patient data and implement adequate privacy protections by design; @@@2) On access controlled NIAAA servers, located in secured space to prevent physical theft of storage media, and managed by NIAAA IT in agreement with NIH data security policies. We will feed some of the data residing in CRIS and on the NIAAA servers to the NIH Biomedical Translational Research Information System (BTRIS).@@@|
Informed Consent Form (ICF)
|Time Frame:||Starting with the first patient recruited to termination of the study.|
|Access Criteria:||All IDP will be shared with other NIH protocols, so that data collected under different studies from a single individual may be combined for analysis when the receiving protocol includes informed consent or a waiver of consent for the use of this data for research. Also, identifiable specimens and data from this protocol may be shared with other protocols for future research after IRB approval and informed consent (or waiver of consent).|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Alcohol Use Disorder