RECRUITING

NIAAA Natural History Protocol

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

NIAAA Natural History Protocol

Quick Facts

Study Start:2015-01-21
Study Completion:2044-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02231840

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>=18 years of age
  2. * Willingness to complete the study including genetic and MRI tests.
  3. * Treatment-seeking individuals (Patients that want to stop alcohol use and will require medical management to achieve sobriety) and
  4. * Non-treatment-seeking participants (Patients or healthy volunteers who want to continue their current alcohol use).
  1. * Individuals \< 18 years of age
  2. * Prisoners
  3. * Pregnant candidates
  4. * Candidates having a severe medical or mental health disorder that would impair participation in the study

Contacts and Locations

Study Contact

Beth A Lee, R.N.
CONTACT
(301) 451-6964
beth.lee@nih.gov
Nancy Diazgranados, M.D.
CONTACT
(301) 496-7515
nancy.diazgranados@nih.gov

Principal Investigator

Nancy Diazgranados, M.D.
PRINCIPAL_INVESTIGATOR
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  • Nancy Diazgranados, M.D., PRINCIPAL_INVESTIGATOR, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-01-21
Study Completion Date2044-12-31

Study Record Updates

Study Start Date2015-01-21
Study Completion Date2044-12-31

Terms related to this study

Keywords Provided by Researchers

  • Phenotypes
  • Genetics
  • Alcohol Use Disorder
  • Natural History

Additional Relevant MeSH Terms

  • Alcohol Use Disorder