Pathological GamblingPhase 2NCT00927563
Tolcapone Treatment of Pathological Gambling
A Phase 2 study testing Tolcapone in people with Pathological Gambling, run by University of Chicago at 1 site in United States.
Trial summary
The goal of the proposed study is to evaluate the efficacy and safety of tolcapone in pathological gambling. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Pathological Gambling
- What is being tested?
- Tolcapone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jul 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women age 21-75;
- Meet diagnostic criteria for current pathological gambling based on DSM-IV criteria and confirmed using the clinician-administered Structured Clinical Interview for Pathological Gambling (SCI-PG) (Grant et al., 2004);
- Gambling behavior within 2 weeks prior to enrollment;
- Women of child bearing age are required to have a negative result on a beta-human chorionic gonadotropin pregnancy test;
- Women of childbearing potential utilizing a medically accepted form of contraception defined as double barrier, oral contraceptive, injectable contraceptive, implantable contraceptive devices, and abstinence.
Who cannot join
- Infrequent gambling (i.e. less than one time per week) that does not meet DSM-IV criteria for PG;
- Unstable medical illness or clinically significant abnormalities on laboratory tests, EKG, or physical examination at screen as determined by the investigator;
- History of elevated liver enzymes (AST/ALT) or other liver abnormalities;
- History of seizures;
- Myocardial infarction within 6 months;
- Current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
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- A need for medication other than tolcapone with possible psychotropic effects or unfavorable interactions as determined by the investigator;
- Clinically significant suicidality (defined as score 2 or higher on HAM-D item 3);
- Current co-morbid Axis I disorder determined by the Structured Clinical Interview for DSM-IV (SCID), (First et al., 1995) - except for nicotine dependence;
- Lifetime history of bipolar disorder type I or II, schizophrenia, or any psychotic disorder determined by SCID;
- Clinically significant cognitive impairment (defined as score less than 88 on 3MS);
- Current or recent (past 3 months) DSM-IV substance abuse or dependence;
- Positive urine drug screen at screening;
- Initiation of psychotherapy or behavior therapy for pathological gambling within 3 months prior to study baseline;
- Previous treatment with tolcapone;
- Treatment with an investigational medication or depot neuroleptics within 3 months;
- Refusal to sign the tolcapone information sheet.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ambulatory Research Center
Minneapolis, Minnesota, 55454
About this study
Official title: Tolcapone Treatment of Pathological Gambling: An Open-Label Study
The goal of the proposed study is to evaluate the efficacy and safety of tolcapone in pathological gambling.
Read the detailed description
The proposed study will consist of 8 weeks of treatment with tolcapone in 10 subjects with pathological gambling. The hypothesis to be tested is that tolcapone will be effective in reducing the urges to gamble in patients with pathological gambling. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.
- Conditions
- Pathological Gambling
- Being tested
- Tolcapone
- Keywords
- Gambling, Addiction
- Medical subject headings
- Gambling, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolcaponeDrug
Also called Brand name: TASMAR
pill, 100-300mg/day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Tolcapone | Experimental | Tolcapone 100-300mg/day Receives: Drug: Tolcapone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression Scale (CGI)
The overall impression of the clinician of the severity of the subject. Scores between 1 and 7 with 1 not being ill at all and 7 being one of the worst cases seen. CGI is assessed at every visit (1-5), but only the final visit will be reported here.
Measured: Visit 5 (final visit)
Secondary outcomes (2)
Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS)
Scale used to measure severity of gambling. Scores could range from 0-40 with 0 being the least severe and 40 being the most severe. Here the total score was used. The PG-YBOCS was completed at every visit (1-5), but the final visit (visit 5) will be the only score reported.
Measured: Visit 5 (final visit)
Gambling Symptom Assessment Scale (G-SAS)
Self report test of severity of gambling on a scale from 0-48 with 48 being the most severe. The G-SAS was performed at every visit (1-5), but only the final visit (visit 5) will be reported here as a final score.
Measured: Visit 5 (final visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pathological GamblingStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jon E Grant, MD, JD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927563
- Sponsor's protocol ID
- 0901M58441
- Status last verified
- Feb 2023
- First submitted
- 12 Jun 2009
- Last updated
- 23 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Grant JE, Odlaug BL, Chamberlain SR, Hampshire A, Schreiber LR, Kim SW. A proof of concept study of tolcapone for pathological gambling: relationships with COMT genotype and brain activation. Eur Neuropsychopharmacol. 2013 Nov;23(11):1587-96. doi: 10.1016/j.euroneuro.2013.07.008. Epub 2013 Aug 6.
PubMed 23953269
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolcapone Treatment of Pathological Gambling: An Open-Label Study
- ClinicalTrials.gov ID
- NCT00927563
- Acronym / sponsor ID
- 0901M58441
- Conditions
- Pathological Gambling
- Keywords
- Gambling, Addiction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 25 Jun 2009 (estimated)
- Results
- Posted 6 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the proposed study is to evaluate the efficacy and safety of tolcapone in pathological gambling.
Detailed description
The proposed study will consist of 8 weeks of treatment with tolcapone in 10 subjects with pathological gambling. The hypothesis to be tested is that tolcapone will be effective in reducing the urges to gamble in patients with pathological gambling. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tolcapone | Experimental | Drug: TolcaponeTolcapone 100-300mg/day |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women age 21-75;
- Meet diagnostic criteria for current pathological gambling based on DSM-IV criteria and confirmed using the clinician-administered Structured Clinical Interview for Pathological Gambling (SCI-PG) (Grant et al., 2004);
- Gambling behavior within 2 weeks prior to enrollment;
- Women of child bearing age are required to have a negative result on a beta-human chorionic gonadotropin pregnancy test;
- Women of childbearing potential utilizing a medically accepted form of contraception defined as double barrier, oral contraceptive, injectable contraceptive, implantable contraceptive devices, and abstinence.
Key exclusion criteria (17 listed)
- Infrequent gambling (i.e. less than one time per week) that does not meet DSM-IV criteria for PG;
- Unstable medical illness or clinically significant abnormalities on laboratory tests, EKG, or physical examination at screen as determined by the investigator;
- History of elevated liver enzymes (AST/ALT) or other liver abnormalities;
- History of seizures;
- Myocardial infarction within 6 months;
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 |
|---|---|---|
| TolcaponeAlso: Brand name: TASMARpill, 100-300mg/day for 8 weeks | Drug | Tolcapone |
Primary outcome
Clinical Global Impression Scale (CGI)
Time frame: Visit 5 (final visit)
The overall impression of the clinician of the severity of the subject. Scores between 1 and 7 with 1 not being ill at all and 7 being one of the worst cases seen. CGI is assessed at every visit (1-5), but only the final visit will be reported here.
2 secondary outcomes
Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS)
Time frame: Visit 5 (final visit)
Gambling Symptom Assessment Scale (G-SAS)
Time frame: Visit 5 (final visit)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23953269Grant JE, Odlaug BL, Chamberlain SR, Hampshire A, Schreiber LR, Kim SW. A proof of concept study of tolcapone for pathological gambling: relationships with COMT genotype and brain activation. Eur Neuropsychopharmacol. 2013 Nov;23(11):1587-96. doi: 10.1016/j.euroneuro.2013.07.008. Epub 2013 Aug 6.
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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.
Jon E Grant, MD, JD principal investigator
University of Minnesota
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 Tolcapone in people with Pathological Gambling, run by University of Chicago at 1 site in United States.
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 5 inclusion and 17 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 23 Feb 2023. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 6 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Global Impression Scale (CGI) (time frame: Visit 5 (final visit)). 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 NCT00927563, 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 23 Feb 2023.