Completed

Double-blind Placebo Controlled Topiramate Trial for Pathological Gamblers

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What is being tested

Topiramate flexible dosage

+ 4-session gambling cognitive restructuring

+ Placebo matching tablets

DrugBehavioral
Who is being recruted

Behavior+2

+ Mental Disorders

+ Disruptive, Impulse Control, and Conduct Disorders

From 21 to 65 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: June 2009
See protocol details

Summary

Principal SponsorUniversity of Sao Paulo
Last updated: May 3, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2009

Actual date on which the first participant was enrolled.

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.

NCT01843699
Principal SponsorUniversity of Sao Paulo
Last updated: May 3, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

38 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMental DisordersDisruptive, Impulse Control, and Conduct DisordersRisk-TakingGambling

Criteria

3 inclusion criteria required to participate
a betting frequency of at least once a week in the last 30 days
current Diagnostic and Statistical Manual Fourth Edition Text Revised (DSM-IV-TR) diagnosis of pathological gambling
women within fertility age had to be already practicing an acceptable contraception method and to be negative at a pregnancy test
14 exclusion criteria prevent from participating
a history of suicide attempt or acute suicide risk
a personal or family history of nephrolithiasis
any blood dyscrasia
breastfeeding for women
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Instituto de Psiquiatria da Universidade de São Paulo

São Paulo, BrazilOpen Instituto de Psiquiatria da Universidade de São Paulo in Google Maps
CompletedOne Study Center