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Protocol Details

(Epi)genetic Modulators of Fear Extinction in Alcohol Dependence

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

15-AA-0127

Sponsoring Institute

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 21
Max Age: 65

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Alcohol;
Alcohol Dependence;
Stress;
Fear Conditioning

Recruitment Keyword(s)

None

Condition(s)

Fear;
Stress;
Alcohol Dependence

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute on Alcohol Abuse and Alcoholism

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.

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Eligibility

INCLUSION AND EXCLUSION CRITERIA:

Inclusion and exclusion criteria will be evaluated following screening conducted under the NIAAA screening protocols (98-AA-009 and/or 14-AA-0181).

INCLUSION CRITERIA:

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

EXCLUSION CRITERIA:

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

-Alcohol abstainer (never consumed alcohol in entire life)

-Left-handedness

-Use of intrauterine device (IUD)


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Citations:

Grant BF, Stinson FS, Dawson DA, Chou SP, Dufour MC, Compton W, Pickering RP, Kaplan K. Prevalence and co-occurrence of substance use disorders and independent mood and anxiety disorders: results from the National Epidemiologic Survey on Alcohol and Related Conditions. Arch Gen Psychiatry. 2004 Aug;61(8):807-16.

Heilig M, Thorsell A, Sommer WH, Hansson AC, Ramchandani VA, George DT, Hommer D, Barr CS. Translating the neuroscience of alcoholism into clinical treatments: from blocking the buzz to curing the blues. Neurosci Biobehav Rev. 2010 Nov;35(2):334-44. doi: 10.1016/j.neubiorev.2009.11.018. Epub 2009 Nov 24.

Goldman D, Oroszi G, Ducci F. The genetics of addictions: uncovering the genes. Nat Rev Genet. 2005 Jul;6(7):521-32.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Falk W. Lohoff, M.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institutes of Health
Building 10
Room 2-2352NE, MS1540
10 Center Drive
Bethesda, Maryland 20892
(301) 827-1542
falk.lohoff@nih.gov

Falk W. Lohoff, M.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institutes of Health
Building 10
Room 2-2352NE, MS1540
10 Center Drive
Bethesda, Maryland 20892
(301) 827-1542
falk.lohoff@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT02438969

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