Trial · NCT01057862
Investigation of Naltrexone for Pathological Gambling
NCT01057862, Phase 2, Completed, Yale University; results first posted 2017-09-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Investigation of Naltrexone for Pathological Gambling. Trials, record NCT01057862. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01057862
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Investigation of Naltrexone for Pathological Gambling
- NCT number
- NCT01057862
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Pathological Gambling
- Interventions
- Naltrexone, Placebo
- First posted
- 2010-01-27
- Last updated
- 2017-10-13
- Results first posted
- 2017-09-12
- Limitations and caveats
Enrollment was lower than expected and due to the low numbers of subjects completing the study (7 subjects completed all interventions) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses.
Source ClinicalTrials.gov
Registered outcomes2
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 (YBOCS-PG) | Weekly/bi-weekly visits | The Yale Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS) was developed to measure the severity and change in severity of pathological gambling symptoms.The PG-YBOCS is a 10-item clinician-administered questionnaire that measures the severity of PG over a specified time interval. Scores of 0 through 4 are assigned to each question according to the severity of the response (0 = least severe response, 4 = most severe response). The first five questions assess urges and thoughts associated with pathological gambling, whereas the last five questions assess the behavioral component of the disorder. Each set of questions is totaled separately as well as together for a total score. The total score can range from 0 (low) to 40 (most severe) with higher numbers representing a more severe form of pathological gambling. |
| Secondary | Gambling Symptom Assessment Scale (G-SAS) | Weekly/bi-weekly visits | The G-SAS is a 12-item self-rated scale designed to assess gambling symptom severity and change during treatment. Each item on the 12-item scale has a score ranging from 0 - 4. All items ask for an average symptom based on the past 7 days. Total score ranges from 0 - 48: extreme = 41 - 48, severe = 31 - 40, moderate = 21 - 30, mild = 8 - 20. |
Source ClinicalTrials.gov
Outcomes2
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 (YBOCS-PG) | Weekly/bi-weekly visits | Enrollment was lower than expected and due to the low numbers of subjects completing the study (7 subjects completed all interventions - 5 naltrexone and 2 placebo) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses. | units on a scale | MEAN |
| SECONDARY | Gambling Symptom Assessment Scale (G-SAS) | Weekly/bi-weekly visits | Enrollment was lower than expected and due to the low numbers of subjects completing the study (8 subjects completed all interventions) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
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 (YBOCS-PG) | Naltrexone | Baseline | 16.0 | Standard Deviation 7.35 | units on a scale |
| Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (YBOCS-PG) | Placebo | Baseline | 17.0 | Standard Deviation 13.54 | units on a scale |
| Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (YBOCS-PG) | Naltrexone | End of Study | 10.0 | Standard Deviation 9.35 | units on a scale |
| Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (YBOCS-PG) | Placebo | End of Study | 4.0 | Standard Deviation 5.65 | units on a scale |
| Gambling Symptom Assessment Scale (G-SAS) | Naltrexone | Baseline | 26.8 | Standard Deviation 11.73 | units on a scale |
| Gambling Symptom Assessment Scale (G-SAS) | Placebo | Baseline | 24.75 | Standard Deviation 11.53 | units on a scale |
| Gambling Symptom Assessment Scale (G-SAS) | Naltrexone | End of Study | 12.6 | Standard Deviation 9.45 | units on a scale |
| Gambling Symptom Assessment Scale (G-SAS) | Placebo | End of Study | 1.0 | Standard Deviation 1.41 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Naltrexone | 5 | |
| Overall Study | STARTED | Placebo | 4 | |
| Overall Study | COMPLETED | Naltrexone | 4 | |
| Overall Study | COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | Naltrexone | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Naltrexone | 0 | 5 |
| Total, all-cause mortality | Placebo | 0 | 4 |
| Total, other adverse events | Naltrexone | 0 | 5 |
| Total, other adverse events | Placebo | 0 | 4 |
| Total, serious adverse events | Naltrexone | 0 | 5 |
| Total, serious adverse events | Placebo | 0 | 4 |
Source ClinicalTrials.gov
Papers9
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 |
|---|---|
| Naltrexone vs Placebo: deaths from any cause | Trial comparisons |
| Naltrexone 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/NCT01057862
GET https://conductscience.org/api/trials/v1/NCT01057862/registered