Topiramate Trial for Pathological Gamblers

Study Overview
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Brief Summary
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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.

Official Title
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Double-blind Placebo Controlled Topiramate Trial for Pathological Gamblers

Conditions
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Pathological Gambling

Intervention / Treatment
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* Drug: Topiramate flexible dosage
* Drug: Placebo matching tablets
* Behavioral: 4-session gambling cognitive restructuring


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topiramate<br>A 12-week topiramate flexible dose administration plus 4 sessions of a manualized cognitive restructuring intervention. | Drug: Topiramate flexible dosage<br> <br> Behavioral: 4-session gambling cognitive restructuring<br> <br> |
| Placebo Comparator: Placebo<br>A 12-week placebo matching tablets plus 4 sessions of a manualized cognitive restructuring intervention. | Drug: Placebo matching tablets<br> <br> Behavioral: 4-session gambling cognitive restructuring<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gambling craving | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gambling behavior | Includes frequency of betting, amount of money and time spent on gambling over a month | 12 weeks |