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Topiramate Trial for Pathological Gamblers

Information source: University of Sao Paulo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pathological Gambling

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

Phase: Phase 2

Status: Completed

Sponsored by: University of Sao Paulo

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.

Clinical Details

Official title: Double-blind Placebo Controlled Topiramate Trial for Pathological Gamblers

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Gambling craving

Secondary outcome: Gambling behavior

Eligibility

Minimum age: 21 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Instituto de Psiquiatria da Universidade de São Paulo, São Paulo 05403-010, Brazil
Additional Information

Starting date: June 2009
Last updated: April 30, 2013

Page last updated: August 23, 2015

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