NCT01843699

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 1, 2013

Completed
Last Updated

May 3, 2013

Status Verified

April 1, 2013

Enrollment Period

1.4 years

First QC Date

April 23, 2013

Last Update Submit

April 30, 2013

Conditions

Pathological Gambling

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (1)

  • Gambling behavior

    12 weeks

Other Outcomes (1)

  • Social adjustment

    12 weeks

Study Arms (2)

Topiramate

EXPERIMENTAL

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

Drug: Topiramate flexible dosageBehavioral: 4-session gambling cognitive restructuring

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo matching tabletsBehavioral: 4-session gambling cognitive restructuring

Interventions

Topiramate flexible dosageDRUG
Topiramate
Placebo matching tabletsDRUG
Placebo
4-session gambling cognitive restructuringBEHAVIORAL
PlaceboTopiramate

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Psiquiatria da Universidade de São Paulo

São Paulo, São Paulo, 05403-010, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 36130734DERIVED

MeSH Terms

Conditions

Gambling

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 23, 2013

First Posted

May 1, 2013

Study Start

June 1, 2009

Primary Completion

November 1, 2010

Last Updated

May 3, 2013

Record last verified: 2013-04

Locations

BR(1)