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Completed

NCT Number: NCT01843699

Topiramate Trial for Pathological Gamblers

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.

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Key information

Conditions

Pathological Gambling Behavior Disruptive, Impulse Control, and Conduct Disorders Gambling Mental Disorders Risk-Taking

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Instituto de Psiquiatria da Universidade de São Paulo

São Paulo, 05403-010, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topiramate flexible dosage

Drug

Placebo matching tablets

Drug

4-session gambling cognitive restructuring

Behavioral

Primary outcomes

  1. Gambling craving

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. Gambling behavior

    Time frame: 12 weeks

    Includes frequency of betting, amount of money and time spent on gambling over a month

Other outcomes

  1. Social adjustment

    Time frame: 12 weeks

    The Social Adjustment Scale (SAS) is a self-report scale that assesses seven specific areas: work, social life and leisure, extended family relationship, marital relationship, relationship with offspring, domestic life and financial situation. References:

    • Weissman MM, Bothwell S, (1976): Assessment of social adjustment by patient self-report. Arch Gen Psychiatry 33:1-5.
    • Gorenstein C, Moreno RA, Bernick MA, Carvalho SC, Nicastri S, Cordas T, et al, (2002): Validation of the Portuguese version of the Social Adjustment Scale on Brazilian samples. Journal of Affective Disorders 69: 167-175.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Double-blind Placebo Controlled Topiramate Trial for Pathological Gamblers

Important dates

Study start
2009
Primary completion
2010
First posted
May 1, 2013
Registry last updated
May 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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