Developing and testing tasks to understand alcohol use disorders
Behavioral and Functional Task Development, Implementation, and Testing
NA · National Institutes of Health Clinical Center (CC) · NCT02108054
This study is trying to create and test new tasks to see how alcohol use disorders affect thinking and decision-making in both healthy people and those with alcohol dependence.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) (nih) |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT02108054 on ClinicalTrials.gov |
What this trial studies
This study aims to create and validate tasks that assess cognitive, motivational, and decision-making behaviors related to alcohol use disorders. Participants, including healthy volunteers and those with alcohol dependence, will undergo screening and may participate in one to three visits. The tasks will be tested using advanced imaging techniques like fMRI, EEG, and fNIRS to explore brain activation patterns associated with these behaviors. The ultimate goal is to enhance understanding of how alcohol use disorders affect behavior and brain function.
Who should consider this trial
Good fit: Ideal candidates include healthy right-handed adults aged 18-65 and inpatient participants diagnosed with alcohol dependence or moderate alcohol use disorder.
Not a fit: Patients currently experiencing withdrawal symptoms from alcohol or those with certain medical conditions that prevent MRI participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved assessment tools for understanding and treating alcohol use disorders.
How similar studies have performed: While studies have explored behavioral tasks in alcohol use disorders, this specific approach using advanced imaging techniques is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: * between 18-65 years of age. The PI or designated AI will determine if any of the exclusion criteria listed below applies\*. EXCLUSION CRITERIA: * Are not cleared on a neuromotor examination * Are currently receiving psychotropic medication * Inpatients only: Currently experiencing symptoms of withdrawal from alcohol (As determined by the most recent measurement within the past 30 days CIWA score \> 8). -MRI Exclusion Criteria: * Presence of ferromagnetic objects in the body including implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metallic fragments in the eye that welders and other metal workers may have; * Are pregnant, as determined by a negative pregnancy test * Left handed * Claustrophobia. * To minimize discomfort and undue burden on the participants, unless available from phone screening, pre-screening, or other NIAAA studies such as 14-AA-0080, 14-AA-0181, we collect the above information as part of this study.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Paule V Joseph, C.R.N.P. — 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.
Conditions: Alcohol Dependence, Alcohol Drinking, Alcoholism, Alcohol Use Disorder, Addiction, fMRI, Phenotype, Imaging