Trial · NCT02337634
Milk Thistle in Pathological Gambling
NCT02337634, Phase 2, Completed, University of Chicago; results first posted 2024-09-04
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Milk Thistle in Pathological Gambling. Trials, record NCT02337634. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02337634
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Milk Thistle in Pathological Gambling
- NCT number
- NCT02337634
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 55 participants, actual
- Lead sponsor
- University of Chicago
- Conditions
- Pathological Gambling, Gambling Disorder
- Interventions
- Placebo, Milk Thistle
- First posted
- 2015-01-13
- Last updated
- 2026-07-07
- Results first posted
- 2024-09-04
- Limitations and caveats
- Limited statistical power due to small sample size.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS) | Once every two weeks for the 8 weeks of the study | 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. |
| Secondary | Clinical Global Impression-Improvement and Severity Scales (CGI-I and CGI-S) | Once every two weeks for the 8 weeks of the study | 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. |
| Secondary | Gambling Symptom Assessment Scale (G-SAS) | 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. |
| Secondary | Hamilton Anxiety Rating Scale (HAM-A) | Once every two weeks for the 8 weeks of the study | 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. |
| Secondary | Sheehan Disability Scale (SDS) | Once every two weeks for the 8 weeks of the study | 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. |
| Secondary | Hamilton Depression Rating Scale (HAM-D) | Once every two weeks for the 8 weeks of the study | 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. |
| Secondary | Perceived Stress Scale (PSS) | Once every two weeks for the 8 weeks of the study | 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. |
| Secondary | Quality of Life Inventory (QOLI) | Once every two weeks for the 8 weeks of the study | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS) | Once every two weeks for the 8 weeks of the study | Participants who had PG-YBOCS data at Week 8 | units on a scale | MEAN |
| SECONDARY | Clinical Global Impression-Improvement and Severity Scales (CGI-I and CGI-S) | Once every two weeks for the 8 weeks of the study | 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. | units on a scale | MEAN |
| SECONDARY | Gambling Symptom Assessment Scale (G-SAS) | Once every two weeks for the 8 weeks of the study | units on a scale | MEAN | |
| SECONDARY | Hamilton Anxiety Rating Scale (HAM-A) | Once every two weeks for the 8 weeks of the study | Participants who had HAM-A data at Week 8 | units on a scale | MEAN |
| SECONDARY | Sheehan Disability Scale (SDS) | Once every two weeks for the 8 weeks of the study | Participants who had SDS data at Week 8 | units on a scale | MEAN |
| SECONDARY | Hamilton Depression Rating Scale (HAM-D) | Once every two weeks for the 8 weeks of the study | Participants who had HAM-D data at Week 8 | units on a scale | MEAN |
| SECONDARY | Perceived Stress Scale (PSS) | Once every two weeks for the 8 weeks of the study | Participants who had PSS data at Week 8 | units on a scale | MEAN |
| SECONDARY | Quality of Life Inventory (QOLI) | Once every two weeks for the 8 weeks of the study | Participants who had QOLI data at Week 8 | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS) | Placebo | -11.76 | Standard Deviation 7.18 | units on a scale | |
| Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS) | Milk Thistle | -11.86 | Standard Deviation 7.75 | units on a scale | |
| Clinical Global Impression-Improvement and Severity Scales (CGI-I and CGI-S) | Placebo | Change in CGI-I score | -0.90 | Standard Deviation 1.67 | units on a scale |
| Clinical Global Impression-Improvement and Severity Scales (CGI-I and CGI-S) | Milk Thistle | Change in CGI-I score | -1.71 | Standard Deviation 1.14 | units on a scale |
| Clinical Global Impression-Improvement and Severity Scales (CGI-I and CGI-S) | Placebo | Change in CGI-S score | -1.5 | Standard Deviation 1.41 | units on a scale |
| Clinical Global Impression-Improvement and Severity Scales (CGI-I and CGI-S) | Milk Thistle | Change in CGI-S score | -1.5 | Standard Deviation 1.38 | units on a scale |
| Gambling Symptom Assessment Scale (G-SAS) | Placebo | -15.54 | Standard Deviation 9.91 | units on a scale | |
| Gambling Symptom Assessment Scale (G-SAS) | Milk Thistle | -19.72 | Standard Deviation 8.55 | units on a scale | |
| Hamilton Anxiety Rating Scale (HAM-A) | Placebo | -3 | Standard Deviation 2.5 | units on a scale | |
| Hamilton Anxiety Rating Scale (HAM-A) | Milk Thistle | -0.43 | Standard Deviation 0.96 | units on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 26 | |
| Overall Study | STARTED | Milk Thistle | 17 | |
| Overall Study | COMPLETED | Placebo | 22 | |
| Overall Study | COMPLETED | Milk Thistle | 16 | |
| Overall Study | NOT COMPLETED | Placebo | 4 | |
| Overall Study | NOT COMPLETED | Milk Thistle | 1 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Placebo | 1 | 26 | 1 |
| other | Headache | Nervous system disorders | Milk Thistle | 3 | 17 | 3 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 1 | 26 | 2 |
| other | Diarrhea | Gastrointestinal disorders | Milk Thistle | 0 | 17 | 0 |
| other | Nausea | Gastrointestinal disorders | Placebo | 2 | 26 | 3 |
| other | Nausea | Gastrointestinal disorders | Milk Thistle | 0 | 17 | 0 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 1 | 26 | 1 |
| other | Vomiting | Gastrointestinal disorders | Milk Thistle | 0 | 17 | 0 |
| other | Reduced appetite | Gastrointestinal disorders | Placebo | 0 | 26 | 0 |
| other | Reduced appetite | Gastrointestinal disorders | Milk Thistle | 1 | 17 | 1 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 26 |
| Total, all-cause mortality | Milk Thistle | 0 | 17 |
| Total, other adverse events | Placebo | 3 | 26 |
| Total, other adverse events | Milk Thistle | 4 | 17 |
| Total, serious adverse events | Placebo | 0 | 26 |
| Total, serious adverse events | Milk Thistle | 0 | 17 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Milk Thistle vs Placebo: deaths from any cause | Trial comparisons |
| Milk Thistle vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02337634
GET https://conductscience.org/api/trials/v1/NCT02337634/registered