Trial Outcomes & Findings for Milk Thistle in Pathological Gambling (NCT NCT02337634)

NCT ID: NCT02337634

Last Updated: 2024-09-04

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 55 participants
• Primary outcome timeframe: Once every two weeks for the 8 weeks of the study
• Results posted on: 2024-09-04

Participant Flow

12 enrolled participants were excluded from the study prior to randomization because they did not meet the inclusion criteria.

Participant milestones

Measure	Placebo Matched dosage of milk thistle daily. Placebo: Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.	Milk Thistle Capsule form, 150mg BID to 300mg BID Milk Thistle: Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.
Overall Study STARTED	26	17
Overall Study COMPLETED	22	16
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Measure	Placebo Matched dosage of milk thistle daily. Placebo: Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.	Milk Thistle Capsule form, 150mg BID to 300mg BID Milk Thistle: Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.
Overall Study Protocol Violation	3	1
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Milk Thistle in Pathological Gambling

Baseline characteristics by cohort

Measure	Placebo n=25 Participants Matched dosage of milk thistle daily. Placebo: Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.	Milk Thistle n=17 Participants Capsule form, 150mg BID to 300mg BID Milk Thistle: Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.	Total n=42 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants	16 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	50.48 years STANDARD_DEVIATION 12.99 • n=5 Participants	48.25 years STANDARD_DEVIATION 13.64 • n=7 Participants	49.6 years STANDARD_DEVIATION 13.24 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	7 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized African American	17 Participants n=5 Participants	13 Participants n=7 Participants	30 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Native American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Not reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	17 participants n=7 Participants	42 participants n=5 Participants
Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS) Score	20.62 units on a scale STANDARD_DEVIATION 3.40 • n=5 Participants	21.17 units on a scale STANDARD_DEVIATION 3.1 • n=7 Participants	20.84 units on a scale STANDARD_DEVIATION 3.36 • n=5 Participants

PRIMARY outcome

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

Population: Participants who had PG-YBOCS data at Week 8

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.

Outcome measures

Measure	Placebo n=21 Participants Matched dosage of milk thistle daily. Placebo: Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.	Milk Thistle n=16 Participants Capsule form, 150mg BID to 300mg BID Milk Thistle: Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.
Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS)	-11.76 units on a scale Standard Deviation 7.18	-11.86 units on a scale Standard Deviation 7.75

SECONDARY outcome

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

Population: There was less participant data analyzed for the CGI-S because several participants were missing this data either for their first or last study visit.

The entire study for an individual subject will last 8 weeks. Every 2 weeks the subject will take the CGIs for the duration of the 8 weeks. Results are reported as the change in Week 8-Week 0 scores. The scales themselves assess overall disorder severity, with higher scores indicating worse outcomes (i.e., less improvement or greater severity). Possible total scores range from 1-7.

Outcome measures

Measure	Placebo n=21 Participants Matched dosage of milk thistle daily. Placebo: Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.	Milk Thistle n=14 Participants Capsule form, 150mg BID to 300mg BID Milk Thistle: Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.
Clinical Global Impression-Improvement and Severity Scales (CGI-I and CGI-S) Change in CGI-I score	-0.90 units on a scale Standard Deviation 1.67	-1.71 units on a scale Standard Deviation 1.14
Clinical Global Impression-Improvement and Severity Scales (CGI-I and CGI-S) Change in CGI-S score	-1.5 units on a scale Standard Deviation 1.41	-1.5 units on a scale Standard Deviation 1.38

SECONDARY outcome

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

Every 2 weeks the subject will take the G-SAS for the duration of the 8-week study. This is a 12-item, reliable and valid, self-rated scale assessing gambling urges, thoughts, and behaviors during the previous seven days. 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 assess severity of gambling symptoms, with a higher score indicating a worse outcome. Each item can be rated with a score of 0-4, with the sum of the 12 items equaling the total score. Possible total scores range from 0-48.

Outcome measures

Measure	Placebo n=22 Participants Matched dosage of milk thistle daily. Placebo: Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.	Milk Thistle n=15 Participants Capsule form, 150mg BID to 300mg BID Milk Thistle: Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.
Gambling Symptom Assessment Scale (G-SAS)	-15.54 units on a scale Standard Deviation 9.91	-19.72 units on a scale Standard Deviation 8.55

SECONDARY outcome

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

Population: Participants who had HAM-A data at Week 8

The entire study for an individual subject will last 8 weeks. Every 2 weeks the subject will take the HAM-A for the duration of the 8 weeks. Results are reported as the change in Week 8-Week 0 scores. The scale itself assess levels of anxiety, with higher scores indicating worse outcomes. Possible total scores range from 0-56.

Outcome measures

Measure	Placebo n=9 Participants Matched dosage of milk thistle daily. Placebo: Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.	Milk Thistle n=7 Participants Capsule form, 150mg BID to 300mg BID Milk Thistle: Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.
Hamilton Anxiety Rating Scale (HAM-A)	-3 units on a scale Standard Deviation 2.5	-0.43 units on a scale Standard Deviation 0.96

SECONDARY outcome

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

Population: Participants who had SDS data at Week 8

The entire study for an individual subject will last 8 weeks. Every 2 weeks the subject will take the SDS for the duration of the 8 weeks. Results are reported as the change in Week 8-Week 0 scores. The scale itself assesses level of disability resulting from gambling (or target disorder), with higher scores indicating worse outcomes. Possible total scores range from 0-30.

Outcome measures

Measure	Placebo n=17 Participants Matched dosage of milk thistle daily. Placebo: Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.	Milk Thistle n=13 Participants Capsule form, 150mg BID to 300mg BID Milk Thistle: Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.
Sheehan Disability Scale (SDS)	-9.94 units on a scale Standard Deviation 10.15	-8 units on a scale Standard Deviation 9.57

SECONDARY outcome

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

Population: Participants who had HAM-D data at Week 8

The entire study for an individual subject will last 8 weeks. Every 2 weeks the subject will take the HAM-D for the duration of the 8 weeks. Results are reported as the change in Week 8-Week 0 scores. The scale itself assesses level of depression, with higher scores indicating worse outcomes. Possible total scores range from 0-52.

Outcome measures

Measure	Placebo n=9 Participants Matched dosage of milk thistle daily. Placebo: Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.	Milk Thistle n=6 Participants Capsule form, 150mg BID to 300mg BID Milk Thistle: Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.
Hamilton Depression Rating Scale (HAM-D)	-2.56 units on a scale Standard Deviation 2.51	-2.33 units on a scale Standard Deviation 2.07

SECONDARY outcome

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

Population: Participants who had PSS data at Week 8

The entire study for an individual subject will last 8 weeks. Every 2 weeks the subject will take the PSS for the duration of the 8 weeks. Results are reported as the change in Week 8-Week 0 scores. The scale itself assesses the level of perceived stress the individual experiences, with higher scores indicating worse outcomes. Possible total scores range from 0-40.

Outcome measures

Measure	Placebo n=9 Participants Matched dosage of milk thistle daily. Placebo: Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.	Milk Thistle n=8 Participants Capsule form, 150mg BID to 300mg BID Milk Thistle: Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.
Perceived Stress Scale (PSS)	-5.44 units on a scale Standard Deviation 3.84	-3.88 units on a scale Standard Deviation 5.99

SECONDARY outcome

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

Population: Participants who had QOLI data at Week 8

The entire study for an individual subject will last 8 weeks. This inventory will be completed at the first and last visit of the study, with only these two points being assessed. Results are reported as the change in Week 8-Week 0 scores. The scale itself assess the subjects overall perceived quality of life, with higher scores indicating better outcomes. Possible total scores range from 1-77.

Outcome measures

Measure	Placebo n=13 Participants Matched dosage of milk thistle daily. Placebo: Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.	Milk Thistle n=10 Participants Capsule form, 150mg BID to 300mg BID Milk Thistle: Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.
Quality of Life Inventory (QOLI)	10.92 units on a scale Standard Deviation 28.61	1.3 units on a scale Standard Deviation 41.42

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Milk Thistle

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=26 participants at risk Matched dosage of milk thistle daily. Placebo: Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.	Milk Thistle n=17 participants at risk Capsule form, 150mg BID to 300mg BID Milk Thistle: Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.
Nervous system disorders Headache	3.8% 1/26 • Number of events 1 • Adverse events were collected from the time participants signed consent until their final Week 8 visit. The definition of adverse events in this study matches the clinicaltrials.gov definition.	17.6% 3/17 • Number of events 3 • Adverse events were collected from the time participants signed consent until their final Week 8 visit. The definition of adverse events in this study matches the clinicaltrials.gov definition.
Gastrointestinal disorders Diarrhea	3.8% 1/26 • Number of events 2 • Adverse events were collected from the time participants signed consent until their final Week 8 visit. The definition of adverse events in this study matches the clinicaltrials.gov definition.	0.00% 0/17 • Adverse events were collected from the time participants signed consent until their final Week 8 visit. The definition of adverse events in this study matches the clinicaltrials.gov definition.
Gastrointestinal disorders Nausea	7.7% 2/26 • Number of events 3 • Adverse events were collected from the time participants signed consent until their final Week 8 visit. The definition of adverse events in this study matches the clinicaltrials.gov definition.	0.00% 0/17 • Adverse events were collected from the time participants signed consent until their final Week 8 visit. The definition of adverse events in this study matches the clinicaltrials.gov definition.
Gastrointestinal disorders Vomiting	3.8% 1/26 • Number of events 1 • Adverse events were collected from the time participants signed consent until their final Week 8 visit. The definition of adverse events in this study matches the clinicaltrials.gov definition.	0.00% 0/17 • Adverse events were collected from the time participants signed consent until their final Week 8 visit. The definition of adverse events in this study matches the clinicaltrials.gov definition.
Gastrointestinal disorders Reduced appetite	0.00% 0/26 • Adverse events were collected from the time participants signed consent until their final Week 8 visit. The definition of adverse events in this study matches the clinicaltrials.gov definition.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time participants signed consent until their final Week 8 visit. The definition of adverse events in this study matches the clinicaltrials.gov definition.
General disorders Dry mouth	3.8% 1/26 • Number of events 1 • Adverse events were collected from the time participants signed consent until their final Week 8 visit. The definition of adverse events in this study matches the clinicaltrials.gov definition.	0.00% 0/17 • Adverse events were collected from the time participants signed consent until their final Week 8 visit. The definition of adverse events in this study matches the clinicaltrials.gov definition.
Gastrointestinal disorders Increased appetite	3.8% 1/26 • Number of events 1 • Adverse events were collected from the time participants signed consent until their final Week 8 visit. The definition of adverse events in this study matches the clinicaltrials.gov definition.	0.00% 0/17 • Adverse events were collected from the time participants signed consent until their final Week 8 visit. The definition of adverse events in this study matches the clinicaltrials.gov definition.

Additional Information

Dr. Jon Grant

University of Chicago

Phone: 7738341325

Email: jgrant4@bsd.uchicago.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place