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Topiramate Trial for Pathological Gamblers

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ClinicalTrials.gov Identifier: NCT01843699
Recruitment Status : Completed
First Posted : May 1, 2013
Last Update Posted : May 3, 2013
Sponsor:
Information provided by (Responsible Party):
Hermano Tavares, University of Sao Paulo

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Pathological Gambling Drug: Topiramate flexible dosage Drug: Placebo matching tablets Behavioral: 4-session gambling cognitive restructuring Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind Placebo Controlled Topiramate Trial for Pathological Gamblers
Study Start Date : June 2009
Actual Primary Completion Date : November 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Topiramate

Arms and Interventions
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Arm Intervention/treatment
Experimental: Topiramate
A 12-week topiramate flexible dose administration plus 4 sessions of a manualized cognitive restructuring intervention.
 Drug: Topiramate flexible dosage
Behavioral: 4-session gambling cognitive restructuring
Placebo Comparator: Placebo
A 12-week placebo matching tablets plus 4 sessions of a manualized cognitive restructuring intervention.
 Drug: Placebo matching tablets
Behavioral: 4-session gambling cognitive restructuring


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Gambling behavior [ Time Frame: 12 weeks ]
    Includes frequency of betting, amount of money and time spent on gambling over a month


Other Outcome Measures:
  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:

    1. Weissman MM, Bothwell S, (1976): Assessment of social adjustment by patient self-report. Arch Gen Psychiatry 33:1-5.
    2. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01843699


Locations
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Brazil
Instituto de Psiquiatria da Universidade de São Paulo
São Paulo, Brazil, 05403-010
Sponsors and Collaborators
University of Sao Paulo
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hermano Tavares, Associate Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01843699    
Other Study ID Numbers: 1341/06
First Posted: May 1, 2013    Key Record Dates
Last Update Posted: May 3, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Gambling
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders
Topiramate
 Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs