Topiramate Trial for Pathological Gamblers

Phase 2

Completed

• Conditions: Pathological Gambling
• Interventions: Drug: Topiramate flexible dosage; Drug: Placebo matching tablets; Behavioral: 4-session gambling cognitive restructuring

• Registration Number: NCT01843699
• Lead Sponsor: University of Sao Paulo

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2010-11
• Status Verified: 2013-04
• Study First Submitted: 2013-04-23
• Study First Submitted QC: 2013-04-26
• Last Update Submitted: 2013-04-30
• Study First Posted: 2013-05-01
• Last Update Posted: 2013-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• current Diagnostic and Statistical Manual Fourth Edition Text Revised (DSM-IV-TR) diagnosis of pathological gambling
• a betting frequency of at least once a week in the last 30 days
• women within fertility age had to be already practicing an acceptable contraception method and to be negative at a pregnancy test.

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Exclusion Criteria

• illiteracy
• breastfeeding for women
• previous history of alcohol abuse/dependence with current elevation of liver enzymes, or a present diagnosis of alcohol abuse/dependence
• past or current drug abuse/dependence, except for nicotine dependence
• history of current or past DSM-IV-TR diagnosis of bipolar disorder, schizophrenia, psychosis or any neuropsychiatric condition causing cognitive impairment
• a history of suicide attempt or acute suicide risk
• severe depression indicated by a score equal to or higher than 30 at the Beck Depression Inventory
• current participation in psychotherapy for pathological gambling, including Gamblers Anonymous in the past 3 months
• current use of mood stabilizers, antidepressants, antipsychotics, except occasional use of benzodiazepines
• cardiovascular disease including a history of heart attack, stroke, arrhythmia, cardiac failure in the past 5 years
• chronic or acute renal and liver failure
• a personal or family history of nephrolithiasis
• immunodeficiency
• any blood dyscrasia.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topiramate	Topiramate flexible dosage	A 12-week topiramate flexible dose administration plus 4 sessions of a manualized cognitive restructuring intervention.
Topiramate	4-session gambling cognitive restructuring	A 12-week topiramate flexible dose administration plus 4 sessions of a manualized cognitive restructuring intervention.
Placebo	Placebo matching tablets	A 12-week placebo matching tablets plus 4 sessions of a manualized cognitive restructuring intervention.
Placebo	4-session gambling cognitive restructuring	A 12-week placebo matching tablets plus 4 sessions of a manualized cognitive restructuring intervention.

Primary Outcome Measures

Name	Time	Method
Gambling craving	12 weeks	The scale selected for this purpose was The Gambling Symptom Assessment Scale (G-SAS), it is a one-dimension self-report scale which assesses mostly gambling craving, related thoughts and behaviors. Reference: Kim SW, Grant JE, Potenza MN, Blanco C, Hollander E. The Gambling Symptom Assessment Scale (G-SAS): a reliability and validity study. Psychiatry Res. 2009 Mar 31;166(1):76-84.

Secondary Outcome Measures

Name	Time	Method
Gambling behavior	12 weeks	Includes frequency of betting, amount of money and time spent on gambling over a month

Trial Locations

Locations (1)

Instituto de Psiquiatria da Universidade de São Paulo; 🇧🇷 São Paulo, Brazil