Topiramate on Gambling-Related Behaviours

NCT00370188 | Withdrawn Phase 2

• 1 other identifier: 96/2006
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The quest for an effective medication therapy for problem gambling remains an important priority for the problem gambling treatment research field. While several medications have been evaluated in controlled clinical trials, no medication has been shown to unequivocally reduce gambling behaviour and, to date, no medication has been approved for treating this disorder. Recently, topiramate, indicated for the treatment of seizure disorders, has shown some promise as a medication therapy for problem gambling. In this project, the efficacy of topiramate will be evaluated in a placebo-controlled clinical trial, the first study to do so. The interaction of the effects of the medication and gambling sub-type will be examined to determine whether the efficacy of topiramate is correlated with the specific biopsychosocial history of the gambler.

Conditions

Gambling

Keywords

problem gambling; topiramate

Outcome Measures

Primary Outcomes (2)

• Y-BOCS

• CPGI

Interventions

Topiramate DRUG

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age either gender
• plays electronic gaming machines (e.g. slot machine, video poker)
• meets DSM IV criteria for pathological gambling

You may not qualify if:

• females pregnant or breastfeeding at study entry
• females of childbearing age and physically able to conceive but not on oral contraceptives or patch, unwilling to take pregnancy self-test before each test session
• females taking oral contraceptives or patch but unwilling to use a barrier method of contraceptive during the course of the study
• occupation involving driving or operating heavy machinery
• BMI \< 20
• hepatic dysfunction or hepatitis, as indicated by elevated INR, low serum albumin, or high bilirubin, or elevated AST, ALT, GGT (\>1.5 times normal)
• clinical evidence of cirrhosis on examination
• renal insufficiency (creatinine \>150)
• history of renal stones
• history of glaucoma
• current seizure disorder
• current use of digoxin
• current use of benzodiazepines
• alcohol consumption \>14 drinks /week
• current use of anti-seizure medications (phenytoin, carbamazepine, valproic acid, primadone), antipsychotic medications (e.g., seroquel), carbonic anhydrase inhibitors (acetazolamide), metformin

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

Related Publications (9)

• Grant JE, Kim SW, Potenza MN. Advances in the pharmacological treatment of pathological gambling. J Gambl Stud. 2003 Spring;19(1):85-109. doi: 10.1023/a:1021227214142.

  PMID: 12635541 BACKGROUND

• Johnson BA, Ait-Daoud N, Akhtar FZ, Ma JZ. Oral topiramate reduces the consequences of drinking and improves the quality of life of alcohol-dependent individuals: a randomized controlled trial. Arch Gen Psychiatry. 2004 Sep;61(9):905-12. doi: 10.1001/archpsyc.61.9.905.

  PMID: 15351769 BACKGROUND

• Dannon PN, Lowengrub K, Gonopolski Y, Musin E, Kotler M. Topiramate versus fluvoxamine in the treatment of pathological gambling: a randomized, blind-rater comparison study. Clin Neuropharmacol. 2005 Jan-Feb;28(1):6-10. doi: 10.1097/01.wnf.0000152623.46474.07.

  PMID: 15711432 BACKGROUND

• Arnone D. Review of the use of Topiramate for treatment of psychiatric disorders. Ann Gen Psychiatry. 2005 Feb 16;4(1):5. doi: 10.1186/1744-859X-4-5.

  PMID: 15845141 BACKGROUND

• Dannon PN. Topiramate for the treatment of kleptomania: a case series and review of the literature. Clin Neuropharmacol. 2003 Jan-Feb;26(1):1-4. doi: 10.1097/00002826-200301000-00001.

  PMID: 12567156 BACKGROUND

• Blaszczynski A, Nower L. A pathways model of problem and pathological gambling. Addiction. 2002 May;97(5):487-99. doi: 10.1046/j.1360-0443.2002.00015.x.

  PMID: 12033650 BACKGROUND

• Steel Z, Blaszczynski A. Impulsivity, personality disorders and pathological gambling severity. Addiction. 1998 Jun;93(6):895-905. doi: 10.1046/j.1360-0443.1998.93689511.x.

  PMID: 9744125 BACKGROUND

• Petry NM, Steinberg KL; Women's Problem Gambling Research Center. Childhood maltreatment in male and female treatment-seeking pathological gamblers. Psychol Addict Behav. 2005 Jun;19(2):226-9. doi: 10.1037/0893-164X.19.2.226.

  PMID: 16011396 BACKGROUND

• Berlant JL. Prospective open-label study of add-on and monotherapy topiramate in civilians with chronic nonhallucinatory posttraumatic stress disorder. BMC Psychiatry. 2004 Aug 18;4:24. doi: 10.1186/1471-244X-4-24.

  PMID: 15315714 BACKGROUND

Related Links

• Information about research at the Centre for Addiction and Mental Health

MeSH Terms

Conditions

Gambling

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Bruna Brands, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Study Record Dates

• First Submitted: August 29, 2006
• First Posted: August 30, 2006
• Study Start: September 1, 2006
• Last Updated: July 22, 2015

Record last verified: 2015-07

Locations

CA (1)