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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT00006204
Eligibility Criteria:
Inclusion Criteria:
* Meets criteria for alcohol dependence and comorbid major depressive disorder.
* Absence of any hazardous drinking within 48 to 120 hours (defined as more than or equal to three drinks/day for females and more than or equal to four drinks/day for males).
* No more than 15 days of complete abstinence prior to study.
Exclusion Criteria:
* Psychiatric conditions including schizophrenia, schizoaffective disorder, any non-bipolar psychiatric disorder, bipolar disorders, primary anxiety disorder, mental retardation, and signs of impaired cognitive functioning.
* Any non-alcohol substance dependence except for nicotine.
* Opioid abuse, opioid dependence, or on opioid maintenance treatment.
* Neurological conditions including epilepsy, history of brain injury, encephalitis, or any organic brain syndrome or focally abnormal electroencephalograph examination (EEG).
* Medical conditions including severe cardiac, liver, kidney, endocrine, hematologic, other impairing or unstable medical condition or impending surgery.
* Persistent elevation of liver enzymes indicating active liver disease.
* Females who are pregnant, or unable or unwilling to use reliable birth control methods.
* Unable to read or understand study forms and agree to informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00006204
Study Brief:
Protocol Section:
NCT00006204