RECRUITING

Characterization Imaging Instruments in Alcoholics and Non-Alcoholics

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: \- People with alcoholism have differences in their brains compared with healthy people. People who are dependent on alcohol also perform differently on behavioral tasks. Researchers want to find out more about these differences. They also want to see if these differences are related to DNA. Objective: \- To see if differences in brain structure relate to personality and behavior differences in people with and without alcohol dependence. Eligibility: \- Adults age 18 and older. Design: * Participants will visit the NIH Clinical Center once during the study. * Participants will be screened with a medical history, EKG, and physical exam. They will give blood and urine samples and undergo a psychiatric interview. * Participants will be asked about their alcohol drinking, to see if they have an alcohol use disorder. * Participants will play three computerized games. Some will play these games inside a magnetic resonance imaging (MRI) scanner. * MRI: strong magnetic field and radio waves take pictures of the brain. Participants lie on a table that slides in and out of a cylinder. They will be in the scanner for about 90 minutes. They may lie still for up to 20 minutes at a time. The scanner makes loud knocking noises. They will get earplugs.

Official Title

Characterization Imaging Instruments for Addiction Neuroimaging Assessments

Quick Facts

Study Start:2014-07-10
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02108080

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or older,
  2. * Have been pre-screened, determined eligible for any NIAAA study, or enrolled in any
  1. * Positive BrAC#,
  2. * Positive urine drug test (UDT) # for benzodiazepines, cocaine, methamphetamines, opiates and tetrahydrocannabinol (THC) for outpatients. Positive UDT for benzodiazepines and THC are not exclusionary for the inpatients. It is common that the inpatients who are treated for AUD withdrawal are treated with benzodiazepines. Positive THC would also not be exclusionary for this study since it tends to be detected over the long period of time after use. However, we will make note of these for the data analysis purposes.
  3. * Task performance (behavioral, fMRI) only: cleared based on neuromotor examination,
  4. * Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments),
  5. * Cannot lie comfortably flat on back for up to 2 hours in the MRI scanner,
  6. * Uncomfortable in enclosed spaces (has claustrophobia) such that they would feel discomfort in the scanner,
  7. * Women: are pregnant#,
  8. * Are left-handed.
  9. * Inpatient participants with alcohol use disorder who have symptoms of alcohol withdrawal as indicated by the most recent measurement within the past 30 days, measured by the Clinical Institute Withdrawal Assessment (CIWA-Ar) score \> 8.
  10. * Subjects excluded from MR scan may still perform the behavioral tasks which would otherwise be performed in the scanner, if they qualify for behavioral tasks. To avoid undue discomfort, burden, and inconvenience this information, if available, can be gathered from routine clinical care or other NIAAA clinical studies and data.
  11. * Participants who meet this exclusion criterion will not participate in any part of this study at the time. They will be re-scheduled for a future date(s) when they do not meet any of the exclusionary criterion.

Contacts and Locations

Study Contact

Beth A Lee, R.N.
CONTACT
(301) 451-6964
beth.lee@nih.gov
Abdolreza Momenan, Ph.D.
CONTACT
(301) 451-6972
rezam@nih.gov

Principal Investigator

Abdolreza Momenan, Ph.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)

  • Abdolreza Momenan, Ph.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 Date2014-07-10
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2014-07-10
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Alcohol
  • Biomarkers
  • Adults
  • Phenotype
  • Imaging
  • Natural History

Additional Relevant MeSH Terms

  • Alcohol Dependence
  • Alcohol Drinking
  • Alcohol-Related Disorders
  • Alcoholism
  • Brain Mapping