CompletedPhase 2

Milk Thistle in Pathological Gambling

United States55 participantsStarted 2015-01

Plain-language summary

The goal of the proposed study is to evaluate the efficacy and safety of silymarin in individuals with gambling disorder. The hypothesis to be tested is that silymarin will be more effective and well tolerated in subjects with gambling disorder compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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; * Previou…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS)

Timeframe: Once every two weeks for the 8 weeks of the study

Trial details

NCT IDNCT02337634

SponsorUniversity of Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12

Results submitted2023-12-04

View on ClinicalTrials.gov More Pathological Gambling trials