Pathological GamblingPhase 2NCT01843699
Topiramate Trial for Pathological Gamblers
A Phase 2 study testing Topiramate flexible dosage and 4-session gambling cognitive restructuring in people with Pathological Gambling, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Pathological Gambling
- What is being tested?
- Topiramate flexible dosage and 4-session gambling cognitive restructuring
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2009to Nov 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Psiquiatria da Universidade de São Paulo
São Paulo, São Paulo, 05403-010
About this study
Official title: Double-blind Placebo Controlled Topiramate Trial for Pathological Gamblers
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.
- Conditions
- Pathological Gambling
- Being tested
- Topiramate flexible dosage, Placebo matching tablets, 4-session gambling cognitive restructuring
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topiramate flexible dosageDrug
Placebo matching tabletsDrug
4-session gambling cognitive restructuringBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Topiramate | Experimental | A 12-week topiramate flexible dose administration plus 4 sessions of a manualized cognitive restructuring intervention. Receives: Drug: Topiramate flexible dosage; Behavioral: 4-session gambling cognitive restructuring |
| Placebo | Placebo comparator | A 12-week placebo matching tablets plus 4 sessions of a manualized cognitive restructuring intervention. Receives: Drug: Placebo matching tablets; Behavioral: 4-session gambling cognitive restructuring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
Gambling behavior
Includes frequency of betting, amount of money and time spent on gambling over a month
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startJun 2009
- Primary completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pathological GamblingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hermano Tavares, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843699
- Sponsor's protocol ID
- 1341/06
- Status last verified
- Apr 2013
- First submitted
- 23 Apr 2013
- Last updated
- 3 May 2013
- Results posted
- No
Publications
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.
PubMed 36130734
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Placebo Controlled Topiramate Trial for Pathological Gamblers
- ClinicalTrials.gov ID
- NCT01843699
- Acronym / sponsor ID
- 1341/06
- Conditions
- Pathological Gambling
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Nov 2010 (actual)
- First posted
- 1 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topiramate | Experimental | Drug: Topiramate flexible dosage, Behavioral: 4-session gambling cognitive restructuringA 12-week topiramate flexible dose administration plus 4 sessions of a manualized cognitive restructuring intervention. |
| Placebo | Placebo comparator | Drug: Placebo matching tablets, Behavioral: 4-session gambling cognitive restructuringA 12-week placebo matching tablets plus 4 sessions of a manualized cognitive restructuring intervention. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topiramate flexible dosage | Drug | Topiramate |
| Placebo matching tablets | Drug | Placebo |
| 4-session gambling cognitive restructuring | Behavioural | Placebo, Topiramate |
Primary outcome
Gambling craving
Time frame: 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.
1 secondary outcome
Gambling behavior
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
- Derived from this study: PubMed 36130734Dowling 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topiramate flexible dosage and 4-session gambling cognitive restructuring in people with Pathological Gambling, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gambling craving (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01843699, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2013.