Milk Thistle in Pathological Gambling

NCT02337634 | Completed Phase 2 Results DMC

• 1 other identifier: 14-0480
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pathological Gambling; Gambling Disorder

Outcome Measures

Primary Outcomes (1)

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

  Every 2 weeks the subject will take the PG-YBOCS for the duration of the 8-week study. At each of these visits the outcome will be assessed, but only one value (change from baseline to week 8) will be reported. The scale itself assesses severity of gambling, with higher scores indicating worse outcomes. The scale includes two subscales: a thought/urge subscale and a behavior subscale. Each subscale contains 5 items to be rated with a score of 0-4. Subscale scores are summed to get a total score. Possible total scores range from 0-40.

  Once every two weeks for the 8 weeks of the study

Secondary Outcomes (7)

• Clinical Global Impression-Improvement and Severity Scales (CGI-I and CGI-S)

  Once every two weeks for the 8 weeks of the study

• Gambling Symptom Assessment Scale (G-SAS)

  Once every two weeks for the 8 weeks of the study

• Hamilton Anxiety Rating Scale (HAM-A)

  Once every two weeks for the 8 weeks of the study

• Sheehan Disability Scale (SDS)

  Once every two weeks for the 8 weeks of the study

• Hamilton Depression Rating Scale (HAM-D)

  Once every two weeks for the 8 weeks of the study

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Matched dosage of milk thistle daily.

Drug: Placebo

Milk Thistle

ACTIVE COMPARATOR

Capsule form, 150mg BID to 300mg BID

Drug: Milk Thistle

Interventions

Placebo DRUG

Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.

Also known as: Sugar Pill

Placebo

Milk Thistle DRUG

Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.

Also known as: Silymarin

Milk Thistle

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (2)

• Grant JE, Driessens C, Chamberlain SR. Silymarin (Milk Thistle) Treatment of Adults With Gambling Disorder: A Double-Blind, Placebo-Controlled Trial. Clin Neuropharmacol. 2024 Mar-Apr 01;47(2):54-58. doi: 10.1097/WNF.0000000000000585.

  PMID: 38478366 DERIVED

• Dowling N, Merkouris S, Lubman D, Thomas S, Bowden-Jones H, Cowlishaw S. Pharmacological interventions for the treatment of disordered and problem gambling. Cochrane Database Syst Rev. 2022 Sep 22;9(9):CD008936. doi: 10.1002/14651858.CD008936.pub2.

  PMID: 36130734 DERIVED

MeSH Terms

Conditions

Gambling

Interventions

Sugars; milk-thistle extract; Silymarin

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates; Flavonolignans; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Limited statistical power due to small sample size.

Results Point of Contact

• Title: Dr. Jon Grant
• Organization: University of Chicago

jgrant4@bsd.uchicago.edu

7738341325

Study Officials

• Jon E Grant, JD, MD, MPH

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: January 13, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 4, 2024
• Results First Posted: September 4, 2024

Record last verified: 2024-02

Locations

US (1)