Kleptomania
Conditions
Keywords
Compulsive Shoplifting, Kleptomania, Compulsive Stealing
Brief summary
The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in kleptomania.
Detailed description
The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 20 subjects with kleptomania. The hypothesis to be tested is that naltrexone will be effective in reducing the urges to steal in patients with kleptomania. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.
Interventions
DRUGNaltrexone
daily
DRUGPlacebo
daily
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. men and women age 21-75 2. current DSM-IV kleptomania.
Exclusion criteria
1. unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination 2. history of seizures 3. myocardial infarction within 6 months 4. current pregnancy or lactation, or inadequate contraception in women of childbearing potential 5. clinically significant suicidality 6. current or recent (past 3 months) DSM-IV substance abuse or dependence 7. illegal substance within 2 weeks of study initiation 8. initiation of psychotherapy or behavior therapy from a mental health professional for the treatment of kleptomania within 3 months prior to study baseline 9. initiation of a psychotropic medication within 2 months prior to study inclusion 10. previous treatment with naltrexone 11. 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 Kleptomania (K-YBOCS) | K-YBOCS is done at each visit by the investigator. | The K-YBOCS measures symptom severity (urges/thoughts and behavior) across the past week. Scores range from 0 (no symptoms) to 40 (highest symptom severity). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Naltrexone Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion. | 12 |
| Placebo Placebo tablets (identical to naltrexone pills) taken by mouth daily. | 13 |
| Total | 25 |
Baseline characteristics
| Characteristic | Placebo | Naltrexone | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 12 Participants | 25 Participants |
| Age, Continuous | 41.4 years STANDARD_DEVIATION 12.7 | 44.3 years STANDARD_DEVIATION 12.2 | 42.6 years STANDARD_DEVIATION 12.4 |
| Region of Enrollment United States | 13 participants | 12 participants | 25 participants |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 13 | 2 / 12 |
| serious Total, serious adverse events | 0 / 13 | 0 / 12 |
Outcome results
Primary
Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS)
The K-YBOCS measures symptom severity (urges/thoughts and behavior) across the past week. Scores range from 0 (no symptoms) to 40 (highest symptom severity).
Time frame: K-YBOCS is done at each visit by the investigator.
Population: Reported scores are Mean and standard deviation for Subjects last visit (Week 8 or last-observation carried forward).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naltrexone | Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS) | 3.83 units on a scale | Standard Deviation 2.86 |
| Placebo | Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS) | 11.46 units on a scale | Standard Deviation 7.76 |