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FearNCT02181608

Traits Associated With Early Life Stress Among Treatment-Seeking Alcoholics

An observational study of Fear and Stress, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Background: Researchers want to see if people with alcohol dependence have more trouble learning to feel calm, or learn to fear things more easily, than non-alcoholics and to study how early life stress (ELS) affects these things. Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Fear, Stress, Alcohol Dependence
How many people
0 participants
Where
No sites listed yet
Study dates
19 Jun 2014to 24 Mar 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
  • Diagnosed with 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
Show all 20Show fewer
  • Minimum score of moderate level of exposure for at least two categories of ELS or score of severe level of exposure for at least on category of ELS as measured by the CTQ (categories include: physical, sexual, and emotional abuse; and physical and emotional neglect; severity level varies by category, and is standardized by the creators of the CTQ)
  • 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
  • Diagnosed with alcohol dependence according to DSM IV
  • Alcohol consumption within the past month provided by self-report
  • Specify alcohol as their preferred drug in a clinical interview
  • 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
  • Minimum score of moderate level of exposure for at least two categories of ELS or score of severe level of exposure for at least on category of ELS as measured by the CTQ (categories include: physical, sexual, and emotional abuse; and physical and emotional neglect; severity level varies by category, and is standardized by the creators of the CTQ)
  • 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

Who cannot join

  • 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 alcohol, nicotine, or caffeine.
  • Major medical problems (e.g., central nervous system (CNS), cardiovascular, respiratory, gastrointestinal (GI), hepatic, renal, endocrine, reproductive) that in the judgment of the MAI, 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
Show all 36Show fewer
  • 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 alcohol, nicotine, or caffeine.
  • Major medical problems (e.g., CNS, cardiovascular, respiratory, GI, hepatic, renal, endocrine, reproductive) that in the judgment of the MAI, 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
  • Score above minimal for one or more categories of ELS as measured by the CTQ
  • -Left-handedness
  • 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 alcohol, nicotine, or caffeine.
  • Major medical problems (e.g., CNS, cardiovascular, respiratory, GI, hepatic, renal, endocrine, reproductive) that in the judgment of the MAI, 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
  • Left-handedness
  • 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 alcohol, nicotine, or caffeine.
  • Major medical problems (e.g., CNS, cardiovascular, respiratory, GI, hepatic, renal, endocrine, reproductive) that in the judgment of the MAI, 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
  • Score above minimal for one or more categories of ELS as measured by the CTQ
  • 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
  • Left-handedness

About this study

Background:

  • Researchers want to see if people with alcohol dependence have more trouble learning to feel calm, or learn to fear things more easily, than non-alcoholics and to study how early life stress (ELS) affects these things.
Read more

Objective:

  • To see if people with alcohol dependence and/or ELS have a harder time learning to feel calm than people without these conditions.

Eligibility:

  • Adults age 21 65 with diagnosed alcohol dependence, with/without ELS.
  • Healthy volunteers age 21 65 with/without ELS.

Design:

  • All participants will be screened with medical history and physical exam. They will have blood and urine tests, and a psychological assessment.
  • Participants with alcohol dependence will:
  • be at the NIH Clinical Center for 4 weeks. Then they will have weekly telephone calls and 3 in-person visits over 3 months.
  • follow the NIH alcohol treatment program during the study. They cannot take psychiatric medications.
  • rate their alcohol craving, depression, and anxiety throughout the study.
  • have fear conditioning and extinction sessions that use noise and mild electric shock. Some take place during a functional MRI (fMRI) scan. Participants will lie in a machine that takes images, while they perform tasks.
  • listen to recordings that describe stressful events. They will rate their feelings and have blood drawn through an intravenous (IV) line.
  • have their hormone response to stress tested. They will take a pill and get a hormone via an IV, then have blood drawn.
  • Healthy volunteers will:
  • have 2 inpatient stays, each lasting a few days. They will answer questions about how they feel.
  • have fear conditioning and extinction sessions, including fMRI.
  • have blood drawn several times.
Read the detailed description

Objective:

The primary objective of the study is to evaluate the role of early life stress (ELS), alcohol dependence (AD), and their interaction in psychophysiology and neural mechanisms of fear conditioning and extinction.

The main outcome of interest is fear extinction, as measured by laboratory-based and fMRI paradigms. Secondary objectives of the study include: (1) explore the impact of early life stress on behavioral and endocrine response to challenge procedures among individuals with AD; (2) explore differences in reward processing, emotion processing, and neural response to alcohol beverages as measured by fMRI as a function of AD and ELS; and (3) examine the relationship between fear extinction and clinical outcomes in our patient sample.

Study Population:

The study sample includes four groups: 1) treatment-seeking individuals with alcohol dependence (AD) and ELS exposure; 2) treatment seeking individuals with alcohol dependence without ELS exposure; 3) healthy social drinkers without alcohol use disorders (AUD) but with ELS exposure; and 4) healthy social drinkers without AUD and without ELS exposure. Target accrual for each of these groups is 25.

Design:

All participants will be evaluated for fear conditioning and extinction using two separate paradigms: an out-of-the scanner shock conditioning extinction procedure that utilizes acoustic startle, and a shock conditioning extinction procedure combined with fMR imaging that utilizes galvanic skin response. In addition, the two alcohol dependent groups will be evaluated for several biomarkers including a guided imagery procedure designed to induce stress and/or craving for alcohol, and an assessment of hypothalamic-pituitary-adrenal (HPA) axis function.

Outcome Measures:

Primary outcome measures include fear-potentiated startle responses and galvanic skin responses; and neural BOLD fMRI responses during presentation of fear associated stimuli. Secondary and exploratory measures in alcohol dependent subjects include measures of distress and craving for alcohol in response to guided imagery scripts; neuroendocrine stress responses and clinical outcomes (alcohol consumption and self-reported anxiety and mood symptoms).

Keywords
Alcohol Dependence, Fear Conditioning, Stress, Alcohol
Medical subject headings
Alcoholism

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To compare physiological and neural outcomes in treatment-seeking alcoholics across multiple challenge procedures as a function of early life stress (ELS) exposure.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2014 (estimated)
  2. Study start19 Jun 2014
  3. Primary completion24 Mar 2015
  4. Study completion24 Mar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02181608
Sponsor's protocol ID
140137
Other IDs
14-AA-0137
Status last verified
24 Mar 2015
First submitted
2 Jul 2014
Last updated
2 Jul 2017
Results posted
No

Publications

  • 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.

    PubMed 19941895

  • Prescott CA, Kendler KS. Genetic and environmental contributions to alcohol abuse and dependence in a population-based sample of male twins. Am J Psychiatry. 1999 Jan;156(1):34-40. doi: 10.1176/ajp.156.1.34.

    PubMed 9892295

  • Chartier KG, Hesselbrock MN, Hesselbrock VM. Development and vulnerability factors in adolescent alcohol use. Child Adolesc Psychiatr Clin N Am. 2010 Jul;19(3):493-504. doi: 10.1016/j.chc.2010.03.004.

    PubMed 20682217

Questions about this trial

What is this clinical trial studying?

An observational study of Fear and Stress, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare physiological and neural outcomes in treatment-seeking alcoholics across multiple challenge procedures as a function of early life stress (ELS) exposure. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02181608, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.

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