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:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT00635102
Eligibility Criteria:
Inclusion / Exclusion Criteria Alcoholic subjects:
* Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs.
* Meet Diagnostic and Statistical Manual (DSM) IV criteria for alcohol dependence by structured clinical interview
* Meet von Knorring criteria for early onset (type II) alcoholism
* Without other DSM IV Axis I diagnoses by Structured Clinical Interview (SCID).
* Without lifetime history of other substance abuse diagnosis by SCID (excluding tobacco) and urine toxicology screen negative for drug of abuse.
* Medically and neurologically healthy on the basis of history, physical examination, sequential multiple analysis-computer (SMAC-20), complete blood count (CBC) w/diff. and EKG. In light of the proximity to alcohol dependence, liver function test (LFT) elevations of twice normal will be accepted into the study.
* Patients with stable medical problems may be included in the study if their medications have not been adjusted in the month prior to participation and if these medications lack prominent central nervous system (CNS) effects.
* Absence of alcohol within the past 15 days.
* Patients must be free of medications utilized to facilitate detoxification (lorazepam, oxazepam) for at least 3 days prior to initiating testing.
* Patients must have no history of alcoholic hallucinosis.
* Patients must not be in acute alcohol withdrawal as evidence by a score no more than 2 for each item of the Clinical Institute Withdrawal Assessment Scale
* Patients taking ethionamide or isoniazid will be not be allowed to participate in the study.
Inclusion / Exclusion Criteria Healthy subjects:
* Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs.
* Absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
* Medically and neurologically healthy on the basis of history, physical examination, SMAC-20, CBC w/diff. and EKG. In light of the proximity to alcohol dependence, LFT elevations of twice normal will be accepted into the study.
* Absence of alcohol within the past 14 days
* Healthy subjects will be matched to the patient group for age, sex and educational level.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT00635102
Study Brief:
Protocol Section:
NCT00635102