At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 83 enrolled
Drug / intervention
Naltrexone +1 moredrug
Likely dose
Naltrexone 50 mg/day, 100 mg/day, or 150 mg/dayAI-extracted
Key inclusion· 5
- ✓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
Key exclusion· 0
None specified.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Naltrexone Treatment in Pathologic Gambling Disorder
In Brief
A Phase 3 clinical trial evaluating Naltrexone and Placebo for Gambling. Completed, enrolled 83 participants across 1 site.
Detailed Summary
This study will establish the best dose of the drug naltrexone to treat patients with Pathological Gambling Disorder (PGD) and severe urge symptoms.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGambling
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)
Timeline
Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2002
First PostedFeb 2003
Primary CompletionNov 2005
TodayJul 2026
First PostedFeb 5, 2003
Enrollment StartDec 1, 2002
Primary CompletionNov 1, 2005
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 23.4 years ago
Interventions
Naltrexonedrug
For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day.
Placebodrug
For subjects who were randomly assigned to placebo.