Milk Thistle in Pathological Gambling

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Treatments: Silymarin

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