Overview

Topiramate Trial for Pathological Gamblers

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Sao Paulo
Treatments:
Topiramate
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.