Traits Associated With Early Life Stress Among Treatment-Seeking Alcoholics

NCT02181608 | Withdrawn

• 2 other identifiers: 14013714-AA-0137
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Fear; Stress; Alcohol Dependence

Keywords

Alcohol Dependence; Fear Conditioning; Stress; Alcohol

Outcome Measures

Primary Outcomes (1)

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

  4 weeks

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Neurological symptoms of the wrist or arm, e.g., carpal tunnel syndrome, as determined by history and physical exam
• 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
• Neurological symptoms of the wrist or arm, e.g., carpal tunnel syndrome, as determined by history and physical exam
• 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
• 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

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): lead

Related Publications (3)

• 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.

  PMID: 19941895 BACKGROUND

• 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.

  PMID: 9892295 BACKGROUND

• 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.

  PMID: 20682217 BACKGROUND

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Vijay A Ramchandani, Ph.D.

  National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 4, 2014
• Study Start: June 19, 2014
• Primary Completion: March 24, 2015
• Study Completion: March 24, 2015
• Last Updated: July 2, 2017

Record last verified: 2015-03-24