| NCT ID | NCT02231840 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| Condition | Alcohol Use Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 7,500 participants |
| Start Date | 2015-01-21 |
| Primary Completion | 2044-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 7,500 participants in total. It began in 2015-01-21 with a primary completion date of 2044-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: \- 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. Objective: -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. Eligibility: * Adults age 18 and older. * Not being pregnant or imprisoned. Design: * 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.
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.
Contact & Investigator
Nancy Diazgranados, M.D.
PRINCIPAL INVESTIGATOR
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Frequently Asked Questions
Who can join the NCT02231840 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02231840 currently recruiting?
Yes, NCT02231840 is actively recruiting participants. Contact the research team at beth.lee@nih.gov for enrollment information.
Where is the NCT02231840 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT02231840 clinical trial?
NCT02231840 is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The principal investigator is Nancy Diazgranados, M.D. at National Institute on Alcohol Abuse and Alcoholism (NIAAA). The trial plans to enroll 7,500 participants.