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The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in compulsive sexual behavior. Twenty subjects with DSM-IV compulsive sexual behavior will receive 8 weeks of naltrexone or placebo. The hypothesis to be tested is that naltrexone will be effective in reducing the urges to act out sexually in patients with compulsive sexual behavior. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.
The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 20 subjects with compulsive sexual behavior.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naltrexone | Active Comparator | Naltrexone 50mg-150mg by mouth per day. |
|
| Placebo | Placebo Comparator | Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone | Drug | daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Yale Brown Obsessive Compulsive Scale Modified for Compulsive Sexual Behavior (YBOCS) | The YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity). | Assessed at each visit (every two weeks) until participation in the study was done (Week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression Scale - Severity | The CGI consists of two reliable and valid 7-item Likert scales used to assess severity in clinical symptoms. The scale ranges from 1 = "very much improved" to 7 = "very much worse." The CGI severity scale was used at each visit and ranges from 1 = "not ill at all" to 7 = "among the most extremely ill." | Assessed at each visit (every two weeks) until participation in the study was done (Week 8) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon E Grant, M.D. | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55454 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Naltrexone | Naltrexone 50mg-150mg by mouth per day. |
| FG001 | Placebo | Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Naltrexone | Naltrexone 50mg-150mg by mouth per day. |
| BG001 | Placebo | Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Clinical Global Impression Scale - Severity | The CGI consists of two reliable and valid 7-item Likert scales used to assess severity in clinical symptoms. The scale ranges from 1 = "very much improved" to 7 = "very much worse." The CGI severity scale was used at each visit and ranges from 1 = "not ill at all" to 7 = "among the most extremely ill." | Reported scores are Mean and standard deviation for Subjects last visit (Week 8 or last-observation carried forward). | Posted | Mean | Standard Deviation | units on a scale | Assessed at each visit (every two weeks) until participation in the study was done (Week 8) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Naltrexone | Naltrexone 50mg-150mg by mouth per day. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jon E. Grant, MD | University of Minnesota | 612-273-9736 | grant045@umn.edu |
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| ID | Term |
|---|---|
| D000096583 | Compulsive Sexual Behavior Disorder |
| D007174 | Disruptive, Impulse Control, and Conduct Disorders |
| ID | Term |
|---|---|
| D016739 | Behavior, Addictive |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| Sugar pill |
| Drug |
daily |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician |
|
|
| Primary | Yale Brown Obsessive Compulsive Scale Modified for Compulsive Sexual Behavior (YBOCS) | The YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity). | Reported scores are Mean and standard deviation for Subjects last visit (Week 8 or last-observation carried forward). | Posted | Mean | Standard Deviation | units on a scale | Assessed at each visit (every two weeks) until participation in the study was done (Week 8) |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Placebo | Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician | 0 | 3 | 0 | 3 |
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| D019968 |
| Sexual and Gender Disorders |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D002241 | Carbohydrates |