Pathological Gambling
Conditions
Keywords
Gambling, Addiction
Brief summary
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.
Interventions
DRUGTolcapone
pill, 100-300mg/day for 8 weeks
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Men and women age 21-75; 2. 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); 3. Gambling behavior within 2 weeks prior to enrollment; 4. Women of child bearing age are required to have a negative result on a beta-human chorionic gonadotropin pregnancy test; 5. Women of childbearing potential utilizing a medically accepted form of contraception defined as double barrier, oral contraceptive, injectable contraceptive, implantable contraceptive devices, and abstinence.
Exclusion criteria
1. Infrequent gambling (i.e. less than one time per week) that does not meet DSM-IV criteria for PG; 2. Unstable medical illness or clinically significant abnormalities on laboratory tests, EKG, or physical examination at screen as determined by the investigator; 3. History of elevated liver enzymes (AST/ALT) or other liver abnormalities; 4. History of seizures; 5. Myocardial infarction within 6 months; 6. Current pregnancy or lactation, or inadequate contraception in women of childbearing potential; 7. A need for medication other than tolcapone with possible psychotropic effects or unfavorable interactions as determined by the investigator; 8. Clinically significant suicidality (defined as score 2 or higher on HAM-D item 3); 9. Current co-morbid Axis I disorder determined by the Structured Clinical Interview for DSM-IV (SCID), (First et al., 1995) - except for nicotine dependence; 10. Lifetime history of bipolar disorder type I or II, schizophrenia, or any psychotic disorder determined by SCID; 11. Clinically significant cognitive impairment (defined as score less than 88 on 3MS); 12. Current or recent (past 3 months) DSM-IV substance abuse or dependence; 13. Positive urine drug screen at screening; 14. Initiation of psychotherapy or behavior therapy for pathological gambling within 3 months prior to study baseline; 15. Previous treatment with tolcapone; 16. Treatment with an investigational medication or depot neuroleptics within 3 months; 17. Refusal to sign the tolcapone information sheet.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression Scale (CGI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS) | Visit 5 (final visit) | 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. |
| Gambling Symptom Assessment Scale (G-SAS) | Visit 5 (final visit) | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited via media advertisement from January 2010 through February 2012 at the University of Minnesota Department of Psychiatry.
Pre-assignment details
Subjects could not be using concomitant use of psychotropic medications with possible effects on PG symptoms (i.e. antidepressants, opioid antagonists)(due to possible interference of results) or have had previous treatment with tolcapone.
Participants by arm
| Arm | Count |
|---|---|
| Tolcapone Tolcapone 100-300mg/day
Tolcapone : pill, 100-300mg/day for 8 weeks | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Tolcapone |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants |
| Age, Continuous | 48.9 years STANDARD_DEVIATION 12.9 |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
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.
Time frame: Visit 5 (final visit)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tolcapone | Clinical Global Impression Scale (CGI) | 2.88 units on a scale | Standard Deviation 1.3 |
Secondary
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.
Time frame: Visit 5 (final visit)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tolcapone | Gambling Symptom Assessment Scale (G-SAS) | 18.67 units on a scale | Standard Deviation 10.58 |
Secondary
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.
Time frame: Visit 5 (final visit)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tolcapone | Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS) | 10.50 units on a scale | Standard Deviation 7.02 |