Clinical trial NCT01843699: Topiramate Trial for Pathological Gamblers
Official title: Double-blind Placebo Controlled Topiramate Trial for Pathological Gamblers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pathological Gambling
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-05-01
Enrollment: 38
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Gambling craving
timeFrame: 12 weeks
Secondary outcomes:
measure: Gambling behavior
timeFrame: 12 weeks
Other outcomes:
measure: Social adjustment
timeFrame: 12 weeks
Locations:
city: São Paulo
country: Brazil
facility: Instituto de Psiquiatria da Universidade de São Paulo
Study officials:
References:
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.