Pathological Gambling
Conditions
Keywords
Pathological Gambling, Compulsive Gambling, Gambling Addiction, Gambling, Treatment, Memantine, Pharmacology
Brief summary
The goal of the proposed study is to evaluate the efficacy and safety of the drug memantine in individuals with pathological gambling (PG). Thirty subjects with DSM-IV PG will receive 10 weeks of open-label treatment with memantine. The hypothesis to be tested is that memantine will be effective and well tolerated in patients with PG. We hypothesize that memantine will reduce the severity of gambling symptoms and improve patients' overall functioning. This study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.
Interventions
DRUGMemantine Hydrochloride
10 mg/day for two weeks, dose increase to 20 mg at week 3, 30 mg at week 4 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks.
Sponsors
University of Minnesota
Forest Laboratories
Yale University
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
* Clinical diagnosis of Pathological Gambling using the clinician-administered Structured Clinical Interview for Pathological Gambling (SCI-PG) (Grant et al., 2004); * Gambling behavior within 2 weeks prior to enrollment; * For women, negative results on a urine pregnancy test and stable use of a medically accepted form of contraception.
Exclusion criteria
* 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; * History of seizures; * Myocardial infarction within 6 months; * Current pregnancy or lactation, or inadequate contraception in women of childbearing potential; * A need for medication other than memantine with possible psychotropic effects or unfavorable interactions; * Clinically significant suicidality; * Current Axis I disorder determined by the SCID and SCID-compatible modules for impulse control disorders (Grant et al., 2005), except for nicotine dependence; * Lifetime history of bipolar disorder type I or II, dementia, schizophrenia, or any psychotic disorder determined by SCID; * Current or recent (past 3 months) DSM-IV substance abuse or dependence; * Positive urine drug screen at screening; * Initiation of psychotherapy or behavior therapy within 3 months prior to study baseline; * Previous treatment with memantine; * Treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS) | Baseline to study end point (10 weeks) | The PGYBOCS is a reliable & valid, 10-item, clinician administered scale that rates gambling symptoms within the last 7 days. The first 5 questions assess urges and thoughts associated with pathological gambling, and the last 5 questions assess the behavioral component of the disorder. Scores of 0 through 4 are assigned each item according to the severity of the response (0 = least severe response or none, 4 = most severe response or extreme)with a score ranging from 0-40. Each set of questions (1-5 and 6-10) can be totaled separately for the component score (urges/thoughts and behavioral) as well as together for a total score. A score of 0 indicates no problems while increasing scores indicate increasing severity of problems with gambling. PG-YBOCS is used to measure changes across time. A decreasing score indicates a possible positive response to the intervention. Total score at baseline was compared with the study end to determine if the intervention was efficacious. |
Countries
United States
Participant flow
Recruitment details
Men and women with a primary diagnosis of Pathological Gambling (PG) were recruited between April 2008 through February 2010
Pre-assignment details
Twenty-eight of the 29 enrolled subjects completed the study with only one subject withdrawing due to time constraints
Participants by arm
| Arm | Count |
|---|---|
| Memantine 10 to 30 mg/day memantine
Memantine Hydrochloride : 10 mg/day for two weeks, dose increase to 20 mg at week 3, 40 mg at week 5 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks. Mean dose at study end was 23.4 ± 8.1 mg/day | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Memantine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Age Continuous | 50.4 years STANDARD_DEVIATION 13 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 29 | 6 / 24 | 8 / 16 |
| serious Total, serious adverse events | 0 / 29 | 0 / 24 | 0 / 16 |
Outcome results
Primary
Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS)
The PGYBOCS is a reliable & valid, 10-item, clinician administered scale that rates gambling symptoms within the last 7 days. The first 5 questions assess urges and thoughts associated with pathological gambling, and the last 5 questions assess the behavioral component of the disorder. Scores of 0 through 4 are assigned each item according to the severity of the response (0 = least severe response or none, 4 = most severe response or extreme)with a score ranging from 0-40. Each set of questions (1-5 and 6-10) can be totaled separately for the component score (urges/thoughts and behavioral) as well as together for a total score. A score of 0 indicates no problems while increasing scores indicate increasing severity of problems with gambling. PG-YBOCS is used to measure changes across time. A decreasing score indicates a possible positive response to the intervention. Total score at baseline was compared with the study end to determine if the intervention was efficacious.
Time frame: Baseline to study end point (10 weeks)
Population: All participants who completed at least one study visit were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Memantine | Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS) | Baseline | 21.8 units on a scale | Standard Deviation 4.3 |
| Memantine | Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS) | 10 weeks | 8.9 units on a scale | Standard Deviation 7.2 |