Gambling
Conditions
Keywords
Impulse Control Disorders
Brief summary
This study will establish the best dose of the drug naltrexone to treat patients with Pathological Gambling Disorder (PGD) and severe urge symptoms.
Detailed description
PGD is a prominent and growing social problem. Unfortunately, there is no established drug treatment for this disorder. Preliminary investigations demonstrate that naltrexone in doses up to 250 mg/day is well tolerated and safe during an 11-week period and may be a viable treatment option for PGD patients with severe urges. The implications of this study extend from PGD to other impulse control disorders, including compulsive shopping, kleptomania, and possibly alcoholism. Participants are randomly assigned to receive either naltrexone or placebo for 16 weeks. The responses of men and women are compared to determine whether efficacy is distributed in a male:female ratio analogous to that of the PGD population in the United States. A Clinical Global Impression and a Gambling Symptom Scale are used to assess participants.
Interventions
DRUGNaltrexone
For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day.
DRUGPlacebo
For subjects who were randomly assigned to placebo.
Sponsors
National Institute of Mental Health (NIMH)
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Diagnostic and Statistical Manual IV criteria for Pathological Gambling Disorder * Moderate or severe gambling urge assessed by the Gambling Symptom Assessment Scale * No psychiatric drug use for 2 weeks or more * Score \>= 5 on The South Oaks Gambling Screen * Hamilton Depression Rating Scale and Anxiety Rating score \< 26. An increase (up to 10 points) of the scores is allowed unless the subject shows the risks of suicide. * Completion of complete blood count, urinalysis, liver and thyroid function tests, and pregnancy tests, with no evidence of significant lab abnormalities * Reliable birth control in women of child-bearing potential
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Yale-Brown Obsessive Compulsive Scale for Pathological Gambling (PG-YBOCS) | 18 weeks | A gambling severity measure derived from the Yale-Brown Obsessive Compulsive Scale. It sums gambling urges and thoughts questions to make a total score. Total scores range from 0 to 40, which higher scores indicating more severe gambling symptoms (worse outcome).Administered every week for the first 8 weeks and every other week for the remaining 10 weeks. Final visit scores were the scores measured at the last visit for each participant; data from previous visits were not combined to compute this value. |
Countries
United States
Participant flow
Pre-assignment details
83 participants began the placebo lead-in phase. 6 of those were placebo responders. The remaining 77 were randomized to Naltrexone or placebo.
Participants by arm
| Arm | Count |
|---|---|
| Naltrexone 17 weeks of double-blind Naltrexone. Subjects were randomized into one of these three conditions (if they weren't randomized to placebo): naltrexone 50mg/day, 100mg/day, 150mg/day. To minimize nausea, treatment for all subjects was initiated at 25mg/day naltrexone for two days, then the dose was increased to 50mg/day. At week 3, subjects were randomly assigned to 50mg/day continued at that dose, while subjects who were randomized to naltrexone 100mg/day or 150mg/day were raised to the higher doses.
Naltrexone: For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day. | 58 |
| Placebo Subjects who were assigned to placebo in the 17 week double-blind phase.
Placebo: For subjects who were randomly assigned to placebo. | 19 |
| Total | 77 |
Baseline characteristics
| Characteristic | Naltrexone | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 47.8 Years STANDARD_DEVIATION 9.65 | 44.7 Years STANDARD_DEVIATION 9.67 | 46.3 Years STANDARD_DEVIATION 9.66 |
| Race/Ethnicity, Customized Race/Ethnicity Other Race | 4 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 54 Participants | 16 Participants | 70 Participants |
| Region of Enrollment United States | 58 participants | 19 participants | 77 participants |
| Sex: Female, Male Female | 37 Participants | 10 Participants | 47 Participants |
| Sex: Female, Male Male | 21 Participants | 9 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 50 / 58 | 17 / 19 |
| serious Total, serious adverse events | 0 / 58 | 0 / 19 |
Outcome results
Primary
Yale-Brown Obsessive Compulsive Scale for Pathological Gambling (PG-YBOCS)
A gambling severity measure derived from the Yale-Brown Obsessive Compulsive Scale. It sums gambling urges and thoughts questions to make a total score. Total scores range from 0 to 40, which higher scores indicating more severe gambling symptoms (worse outcome).Administered every week for the first 8 weeks and every other week for the remaining 10 weeks. Final visit scores were the scores measured at the last visit for each participant; data from previous visits were not combined to compute this value.
Time frame: 18 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naltrexone | Yale-Brown Obsessive Compulsive Scale for Pathological Gambling (PG-YBOCS) | Baseline | 16.9 units on a scale | Standard Deviation 6.6 |
| Naltrexone | Yale-Brown Obsessive Compulsive Scale for Pathological Gambling (PG-YBOCS) | Final Visit Score | 9.7 units on a scale | Standard Deviation 8.12 |
| Placebo | Yale-Brown Obsessive Compulsive Scale for Pathological Gambling (PG-YBOCS) | Final Visit Score | 12.9 units on a scale | Standard Deviation 9.31 |
| Placebo | Yale-Brown Obsessive Compulsive Scale for Pathological Gambling (PG-YBOCS) | Baseline | 18.6 units on a scale | Standard Deviation 4.9 |