Examining brain differences in alcoholics and non-alcoholics
Characterization Imaging Instruments for Addiction Neuroimaging Assessments
This study looks at how the brains of people with alcohol dependence differ from those without it to see if these differences are linked to personality traits and genetics.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT02108080 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the differences in brain structure and function between individuals with alcohol dependence and those without. Participants will undergo a series of assessments, including medical history, psychiatric interviews, and MRI scans, to evaluate their brain imaging and behavioral responses. The study seeks to correlate these brain differences with personality traits and genetic factors related to neurotransmitter activity. By understanding these relationships, researchers hope to gain insights into the neurobiological underpinnings of alcohol use disorders.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older, both with and without alcohol use disorders.
Not a fit: Patients who are actively seeking treatment for alcohol dependence may not benefit from this observational study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment strategies for individuals with alcohol use disorders.
How similar studies have performed: Other studies have shown success in using brain imaging to understand alcohol dependence, making this approach both relevant and promising.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA:
All adult participants must be:
* Age 18 years or older,
* Have been pre-screened, determined eligible for any NIAAA study, or enrolled in any
NIAAA study (including 14-AA-0181).
EXCLUSION CRITERIA:
As this is a natural history protocol, there are no exclusionary criteria for this study.
Participants should have been tested negative prior to the time of consent and study procedures using an alcohol breathalyzer, urine drug (UDT) and, when applicable, pregnancy tests. Individuals with a positive breath alcohol concentration (BrAC), UDT, or pregnancy test will be re-scheduled or withdrawn from the study.
Upon completion of the consent, the participant will be invited for the study session. On the study session day, the following exclusion criteria will be applied.
-Exclusion criteria for MR scan\*
* Positive BrAC#,
* Positive urine drug test (UDT) # for benzodiazepines, cocaine, methamphetamines, and opiates for outpatients. Positive UDT for benzodiazepines is 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.
* Task performance (behavioral, fMRI) only: cleared based on neuromotor examination,
* 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),
* Cannot lie comfortably flat on back for up to 2 hours in the MRI scanner,
* Uncomfortable in enclosed spaces (has claustrophobia) such that they would feel discomfort in the scanner,
* Women: are pregnant#,
* Are left-handed.
* 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.
* 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.
* 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Nancy Diazgranados, M.D. — National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study coordinator: Beth A Lee, R.N.
- Email: beth.lee@nih.gov
- Phone: (301) 451-6964
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.