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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT00226694
Eligibility Criteria:
Inclusion Criteria:
* Able to provide written consent.
* Are actively engaged in a recovery program for alcoholism;
* Have a current (within the past 12 months) diagnosis of DSM-IV alcohol dependence in early- (modified to a minimum of 4 months) full remission; and
* Are residing in a controlled sober living environment; and
* Agree to provide at least one collateral informant who knows the subject well and can attest to their sobriety (recovering alcoholics only).
Exclusion Criteria:
* Have evidence of any clinically significant laboratory evidence of hematologic, hepatic, cardiovascular, renal, pulmonary, thyroid or other endocrine disease;
* Are taking oral contraceptives or other hormonal replacements (e.g., estrogen or progesterone);
* Are pregnant, or planning to become pregnant during the next 9 months;
* Have taken other psychotropic drugs (including SSRIs, MAO inhibitors and other antidepressants, antipsychotics, mood stabilizers, non-benzodiazepine anxiolytics or hypnotics) within 6 weeks of the first laboratory session;
* Have taken any investigational drug within 90 days of the first laboratory session; or
* Are making efforts to quit smoking or have taken any pharmacotherapies for smoking cessation (i.e., bupropion, nicotine-replacement patches or gum; clonidine, buspirone) within 90 days of the first laboratory session.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00226694
Study Brief:
Protocol Section:
NCT00226694