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 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT02337634
Eligibility Criteria:
Inclusion Criteria:
* Men and women age 18-75;
* Diagnosis of current gambling disorder based on DSM-5 criteria and confirmed using the clinician-administered Structured Clinical Interview for Pathological Gambling (SCI-PG) (12);
* Gambling behavior within 2 weeks prior to enrollment;
* Women of child bearing age are required to have a negative result on a beta-human chorionic gonadotropin pregnancy test;
* Women of childbearing potential utilizing a medically accepted form of contraception defined as double barrier, oral contraceptive, injectable contraceptive, implantable contraceptive devices, and abstinence
Exclusion Criteria:
* Infrequent gambling (i.e. less than one time per week) that does not meet DSM-5 criteria for gambling disorder;
* Unstable medical illness or clinically significant abnormalities on laboratory tests, EKG, or physical examination at screen as determined by the investigator;
* History of seizures;
* Myocardial infarction within 6 months;
* Current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
* A need for medication other than milk thistle with possible psychotropic effects or unfavorable interactions as determined by the investigator;
* Clinically significant suicidality (defined by the Columbia Suicidal Scale);
* Lifetime history of bipolar disorder type I or II, schizophrenia, or any psychotic disorder;
* Initiation of psychotherapy or behavior therapy within 3 months prior to study baseline;
* Previous treatment with milk thistle
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02337634
Study Brief:
Protocol Section:
NCT02337634