Phase 3
N=77
Drug Treatment for Pathologic Gambling Disorder
Gambling
Bottom Line
View on ClinicalTrials.gov: NCT00053677 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Yale-Brown Obsessive Compulsive Scale for Pathological Gambling (PG-YBOCS) — 16.9; 18.6; 9.7; 12.9 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Naltrexone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Nov 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Yale-Brown Obsessive Compulsive Scale for Pathological Gambling (PG-YBOCS) |
16.9; 18.6; 9.7; 12.9 | — |
Summary
This study will establish the best dose of the drug naltrexone to treat patients with Pathological Gambling Disorder (PGD) and severe urge symptoms.
Eligibility Criteria
Inclusion Criteria
- Diagnostic and Statistical Manual IV criteria for Pathological Gambling Disorder
- Moderate or severe gambling urge assessed by the Gambling Symptom Assessment Scale
- No psychiatric drug use for 2 weeks or more
- Score >= 5 on The South Oaks Gambling Screen
- Hamilton Depression Rating Scale and Anxiety Rating score < 26. An increase (up to 10 points) of the scores is allowed unless the subject shows the risks of suicide.
- Completion of complete blood count, urinalysis, liver and thyroid function tests, and pregnancy tests, with no evidence of significant lab abnormalities
- Reliable birth control in women of child-bearing potential
Data sourced from ClinicalTrials.gov (NCT00053677). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.