Topiramate Trial for Pathological Gamblers
NCT01843699 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2013-05-03
Summary
Objectives: Pathological gambling (PG) is a prevalent disorder with no approved pharmacological treatment. Previous reports suggest that topiramate could be useful in reducing impulsivity in PG, and craving in other addictions. The goal of this study was to investigate the effectiveness of topiramate combined with brief cognitive restructuring in treating PG. Methods: 38 PG patients were randomized to either topiramate (N=18) or placebo (N=20) in a 12-week double-blind trial; all patients received brief cognitive restructuring. The main outcome measures were craving, gambling behaviour, gambling cognitive distortions, impulsivity, depression and social adjustment.
Conditions
- Pathological Gambling
Interventions
- DRUG
-
Topiramate flexible dosage
- DRUG
-
Placebo matching tablets
- BEHAVIORAL
-
4-session gambling cognitive restructuring
Sponsors & Collaborators
-
University of Sao Paulo
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-06-30
- Primary Completion
- 2010-11-30
Countries
- Brazil
Study Locations
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