Epi-Genetic Modulators of Fear Extinction in Alcohol Dependence

Completed

Conditions studied: Fear, Stress, Alcohol Dependence

In brief

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.

Key facts

Study ID: NCT02438969
Run by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
People needed: 96
Starts: 2015-08-13
Expected to finish: 2022-12-31
Last updated by the study team: 2026-02-17

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

INCLUSION CRITERIA FOR AUD GROUP:
Between 21 and 65 years of age
Ability to provide written informed consent as determined by successful completion of consent quiz prior to signing consent
Females: Negative urine pregnancy test, not currently breastfeeding, agree to abstain or use accepted form of contraception
Diagnosed with current alcohol dependence according to Diagnostic and Statistical Manual for Mental Disorders-Fourth Edition (DSM IV)
Alcohol consumption within the past month provided by self-report
Specify alcohol as their preferred drug in a clinical interview
98-AA-0009 and/or 14-AA-0181 screening consents signed
Cleared venous access assessment
Additional inclusion criteria for non-treatment seeking AUD: Able and willing to abstain from consuming alcohol 1 day prior to each study visit
INCLUSION CRITERIA FOR NON-AUD (HEALTHY VOLUNTEER) GROUP:
Between 21 and 65 years of age
Ability to provide written informed consent as determined by successful completion of consent quiz prior to signing consent
Females: Negative urine pregnancy test, not currently breastfeeding, agree to abstain or use accepted form of contraception
98-AA-0009 and/or 14-AA-0181 screening consents signed
Cleared venous access assessment

You may not qualify if…

EXCLUSION CRITERIA FOR AUD GROUP:
Neurological symptoms of the wrist or arm, e.g., carpal tunnel syndrome, as determined by history and physical exam
Chronic use of psychotropic medications within four weeks of the study, with the exception of fluoxetine, for which the exclusionary time period is six weeks. Incidental use of psychotropic medications is allowed, but any use must be discontinued prior to the study for a time period exceeding 5 half-lives of the medication in question.
Presence of any current or past DSM IV diagnosis of bipolar disorder, or psychotic disorder (e.g, schizophrenia, schizoaffective disorder), or current substance dependence other than alcohol, nicotine, or caffeine.
Major medical problems (e.g., central nervous system (CNS), cardiovascular, respiratory, gastrointestinal (GI), hepatic, renal, endocrine, HIV, reproductive) that in the judgment of the PI, in consultation with relevant Clinical Center consult services, cannot be adequately managed at the Clinical Center.
Presence of ferromagnetic objects in the body, fear of enclosed spaces, or other standard contraindication to MRI, as determined by self-report
Left-handedness
Use of intrauterine device (IUD)
Excluded from the optional DEX-CRH test if:
Allergy to dexamethasone or CRH
Use of medications that can affect the results of the test, including certain antibiotics, anti-seizure drugs, corticosteroids, and hormonal contraception
Additional exclusionary criteria for non-treatment seeking AUD:
Presence of significant alcohol withdrawal symptoms, defined as a CIWA-Ar > 8.
History of epilepsy or alcohol-related seizures.
Are currently seeking treatment for alcohol problems
EXCLUSION CRITERIA FOR NON-AUD (HEALTHY VOLUNTEER) GROUP:
Neurological symptoms of the wrist or arm, e.g., carpal tunnel syndrome, as determined by history and physical exam.
Chronic use of psychotropic medications within four weeks of the study, with the exception of fluoxetine, for which the exclusionary time period is six weeks. Incidental use of psychotropic medications is allowed, but any use must be discontinued prior to the study for a time period exceeding 5 half-lives of the medication in question.
Presence of any current or past DSM IV diagnosis of bipolar disorder, or psychotic disorder (e.g, schizophrenia, schizoaffective disorder), or substance dependence other than nicotine, or caffeine.
Major medical problems (e.g., CNS, cardiovascular, respiratory, GI, hepatic, renal, endocrine, HIV, reproductive) that in the judgment of the PI, in consultation with relevant Clinical Center consult services, cannot be adequately managed at the Clinical Center
Presence of ferromagnetic objects in the body, fear of enclosed spaces, or other standard contraindication to MRI, as determined by self-report
Current or past DSM IV diagnosis of alcohol dependence or abuse
Currently seeking treatment for alcohol problems as assessed by self-report
Positive urine drug test at screening (for opiates, cannabinoids, amphetamines, cocaine, benzodiazepines)
Positive breathalyzer test at screening

Where it is running

National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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