Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT02438969
Eligibility Criteria:
* 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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT02438969
Study Brief:
Protocol Section:
NCT02438969