NCT02108054 Behavioral and Functional Task Development, Implementation, and Testing
| NCT ID | NCT02108054 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| Condition | Alcohol Dependence |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2014-05-28 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2014-05-28 with a primary completion date of 2026-12-31.
⚠ 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: \- Scientists know that alcohol use disorders affect brain structure. They want to know more about the effects of alcohol use disorders on a person s behavior. They want to develop tasks that can be done inside a scanner that can help them better understand these effects in later studies. Objective: \- To develop tasks that investigate a person s behavior that can be used in later studies. Eligibility: * Inpatient participants of another study. They must be physically healthy right-handed adults 18-60 years old. * Healthy right-handed volunteers 18-65 years old. Design: * Participants will be screened with medical history and physical exam. They will have an EKG to record heart activity. They will give blood and urine samples and have a psychiatric interview. * Participants will have between one and three visits. * Participants will be asked about their alcohol drinking to see if they have an alcohol use disorder. * Participants will complete one of three simple computerized tasks either inside the magnetic resonance imagining (MRI) scanner or outside of it. * The MRI scanner takes pictures of the brain. The scanner is a metal cylinder. Participants lie on a table that can slide in and out of the cylinder. They will be in the scanner for about 60 minutes. They may have to lie still for up to 20 minutes. The scanner makes loud knocking noises, but they will get earplugs.
Eligibility 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.
Contact & Investigator
Paule V Joseph, C.R.N.P.
PRINCIPAL INVESTIGATOR
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Frequently Asked Questions
Who can join the NCT02108054 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Alcohol Dependence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02108054 currently recruiting?
Yes, NCT02108054 is actively recruiting participants. Contact the research team at beth.lee@nih.gov for enrollment information.
Where is the NCT02108054 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT02108054 clinical trial?
NCT02108054 is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The principal investigator is Paule V Joseph, C.R.N.P. at National Institute on Alcohol Abuse and Alcoholism (NIAAA). The trial plans to enroll 400 participants.