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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT01847469
Eligibility Criteria:
Inclusion Criteria:
* Current alcohol dependence, as determined by a structured clinical interview (Structured Clinical Interview for DSM-IV Axis I Disorders) (SCID)
* Current PTSD as determined by a structured clinical interview (SCID)
* Veterans with current alcohol dependence, with at least one recent episode of heavy drinking over the past 14 days.
* Medically and neurologically healthy on the basis of history, physical examination, EKG, screening laboratories
* For women, negative pregnancy test and use of acceptable method of contraception
Exclusion Criteria:
* Females who are pregnant or lactating.
* Veterans with a current unstable medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology, which in the opinion of the physician would preclude the subject from fully cooperating or be of potential harm during the course of the study
* Veterans who meet current SCID criteria for a major Axis I diagnosis (Bipolar Disorders, Schizophrenia and Schizophrenia-type Disorders).
* History of substance dependence (other than alcohol, tobacco or cannabis) by DSM-IV criteria in the last 90 days.
* Veterans taking mood stabilizers and antipsychotic medications for specific psychiatric disorders.
* Veterans with a history of allergy to zonisamide.
* Veterans already receiving CPT.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT01847469
Study Brief:
Protocol Section:
NCT01847469