Pathological Gambling
Conditions
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.
Interventions
DRUGTopiramate flexible dosage
DRUGPlacebo matching tablets
BEHAVIORAL4-session gambling cognitive restructuring
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gambling craving | 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
| Measure | Time frame | Description |
|---|---|---|
| Gambling behavior | 12 weeks | Includes frequency of betting, amount of money and time spent on gambling over a month |
Other
| Measure | Time frame | Description |
|---|---|---|
| Social adjustment | 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. |
Countries
Brazil
Outcome results
None listed