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NCT02438969 · ClinicalTrials.gov registry record
Epi-Genetic Modulators of Fear Extinction in Alcohol Dependence
A clinical trial, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Completed
- Registry status
- 96
- Enrollment target
NCT02438969: Completed study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
NCT02438969 is a clinical trial that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 96 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02438969 has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- COMPLETED
- Registry status
- 96 participants
- Enrollment target
Study Summary
Background: \- Researchers want to learn if people with alcohol dependence have more difficulty learning to feel calm, or learn to fear things more easily. They also want to study how early life stress (ELS) affects the ability to learn to feel calm. Objective: \- To see if people with alcohol dependence and/or ELS have a harder time learning to feel calm than people without these. Also, to see if DNA is changed by ELS and if this change affects fear conditioning and extinction. Eligibility: * Adults ages 21-65 with and without an alcohol use disorder (AUD) and with and without ELS. * Healthy volunteers. Design: * Participants will be screened with: * Medical history * Physical exam * Blood and urine tests * Psychological tests * Treatment for symptoms of alcohol withdrawal, if needed * Healthy volunteers will have 1 overnight visit (2 days, 1 night). AUD participants will stay at the clinic for about 4 weeks. * Participants will: * Rate alcohol use/craving, depression, anxiety, and childhood trauma. * Have psychophysiological measures: electrodes and mild electric shock. * Have a functional magnetic resonance imaging (MRI) scan. Participants will lie on a table in a metal cylinder with a coil over their head. In the first scanning session, they will see pictures, do a simple task, and may get shocks. Participants will also do a second scanning session in which they will perform the aforementioned fear conditioning and extinction task, as well as a facial expression matching task, an affective word processing task, and a task measuring valuation of monetary rewards. * Answer questions about their emotions (some participants). * Have blood drawn from an arm vein or intravenous (IV) line. * AUD participants will get a dexamethasone pill. The next day, they will get a hormone injected in and have blood drawn from an IV line. * AUD participants will have 3 follow-up visits with questions and blood and lab tests.
Primary Outcome
1\) Fear extinction (extinction learning) is disrupted in AUD and differs between normal controls with or without ELS and AUD with or without ELS as measured by behavior (skin conductance response) and by fMRI (region of interest BOLD activation). 1a) AUD with ELS will have more severe disruption in their extinction learning phenotype. 2) Neuronal mechanisms involved in abnormal fear extinction in AUD include decreased vmPFC activation during fear which results in impaired inhibitory top-down co
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2015-08-13 |
| Est. Completion | 2022-12-31 |
What the finished NCT02438969 record still lists
NCT02438969 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 96 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02438969 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02438969 about?
NCT02438969 is a clinical study titled "Epi-Genetic Modulators of Fear Extinction in Alcohol Dependence". Background: \- Researchers want to learn if people with alcohol dependence have more difficulty learning to feel calm, or learn to fear things more easily. They also want to study how early life stress (ELS) affects the ability to learn to feel calm. Objective: \- To see if people with alcohol de...
What is the current status of trial NCT02438969?
This trial is currently completed. The enrollment target is 96 participants. The study started on 2015-08-13. Estimated completion is 2022-12-31.
Who is sponsoring clinical trial NCT02438969?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
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