Topiramate Trial for Pathological Gamblers

University of Sao Paulo

Status and phase: Completed; Phase 2

Conditions: Pathological Gambling

Treatments: Behavioral: 4-session gambling cognitive restructuring; Drug: Topiramate flexible dosage; Drug: Placebo matching tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT01843699

1341/06

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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38 participants in 2 patient groups, including a placebo group

Topiramate

Experimental group

Description:

A 12-week topiramate flexible dose administration plus 4 sessions of a manualized cognitive restructuring intervention.

Treatment:

Drug: Topiramate flexible dosage

Behavioral: 4-session gambling cognitive restructuring

Placebo

Placebo Comparator group

Description:

A 12-week placebo matching tablets plus 4 sessions of a manualized cognitive restructuring intervention.

Treatment:

Drug: Placebo matching tablets

Behavioral: 4-session gambling cognitive restructuring