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Traits Associated With Early Life Stress Among Treatment-Seeking Alcoholics

NCT02181608 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2017-07-02

No results posted yet for this study

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

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    lead NIH

Principal Investigators

  • Vijay A Ramchandani, Ph.D. · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-19
Primary Completion
2015-03-24
Completion
2015-03-24

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02181608 on ClinicalTrials.gov