Topiramate Trial for Pathological Gamblers

Pathological Gambling Clinical Trial

Official title:

Double-blind Placebo Controlled Topiramate Trial for Pathological Gamblers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01843699
• Other study ID #: 1341/06
• Status: Completed
• Phase: Phase 2
• First received: April 23, 2013
• Last updated: April 30, 2013
• Start date: June 2009

Study information

• Verified date: April 2013
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Information System on Research Ethics Involving Human Beings (SISNEP - http://portal2.saude.gov.br/sisnep/)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gambling
• Pathological Gambling

Intervention

Drug:
• Topiramate flexible dosage

• Placebo matching tablets

Behavioral:
• 4-session gambling cognitive restructuring

Locations

Country	Name	City	State
Brazil	Instituto de Psiquiatria da Universidade de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Social adjustment	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.	12 weeks	No
Primary	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	No
Secondary	Gambling behavior	Includes frequency of betting, amount of money and time spent on gambling over a month	12 weeks	No