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Topiramate Trial for Pathological Gamblers

Primary Purpose

Pathological Gambling

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Topiramate flexible dosage
Placebo matching tablets
4-session gambling cognitive restructuring
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pathological Gambling

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Instituto de Psiquiatria da Universidade de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Topiramate

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Gambling craving
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

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

Full Information

First Posted
April 23, 2013
Last Updated
April 30, 2013
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01843699
Brief Title
Topiramate Trial for Pathological Gamblers
Official Title
Double-blind Placebo Controlled Topiramate Trial for Pathological Gamblers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pathological Gambling

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topiramate
Arm Type
Experimental
Arm Description
A 12-week topiramate flexible dose administration plus 4 sessions of a manualized cognitive restructuring intervention.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A 12-week placebo matching tablets plus 4 sessions of a manualized cognitive restructuring intervention.
Intervention Type
Drug
Intervention Name(s)
Topiramate flexible dosage
Intervention Type
Drug
Intervention Name(s)
Placebo matching tablets
Intervention Type
Behavioral
Intervention Name(s)
4-session gambling cognitive restructuring
Primary Outcome Measure Information:
Title
Gambling craving
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Gambling behavior
Description
Includes frequency of betting, amount of money and time spent on gambling over a month
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Social adjustment
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Instituto de Psiquiatria da Universidade de São Paulo
City
São Paulo
ZIP/Postal Code
05403-010
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
36130734
Citation
Dowling N, Merkouris S, Lubman D, Thomas S, Bowden-Jones H, Cowlishaw S. Pharmacological interventions for the treatment of disordered and problem gambling. Cochrane Database Syst Rev. 2022 Sep 22;9(9):CD008936. doi: 10.1002/14651858.CD008936.pub2.
Results Reference
derived

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Topiramate Trial for Pathological Gamblers

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