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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02181608 |
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Date of registration:
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02/07/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Traits Associated With Early Life Stress Among Treatment-Seeking Alcoholics
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Scientific title:
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Traits Associated With Early Life Stress Among Treatment-Seeking Alcoholics |
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Date of first enrolment:
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June 19, 2014 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02181608 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Vijay A Ramchandani, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
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Key inclusion & exclusion criteria
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- INCLUSION CRITERIA:
Inclusion criteria for AD+/ELS+ 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
- 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)
Inclusion criteria for AD+/ELS- 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
- 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
Inclusion criteria for AD-/ELS+ 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
- 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)
Inclusion criteria for AD-/ELS- 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
EXCLUSION CRITERIA:
Exclusion criteria for AD+/ELS+ 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 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
Exclusion criteria for AD+/ELS- 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 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
Exclusion criteria for AD-/ELS+ 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 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
Exclusion criteria for AD-/ELS- group:
- Neurolog
Age minimum:
21 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Alcohol Dependence
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Stress
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Fear
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Primary Outcome(s)
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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]
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Secondary ID(s)
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14-AA-0137
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140137
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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