Compulsive Sexual Behavior
Conditions
Keywords
Impulse Control Disorder, Compulsive Sexual Behavior
Brief summary
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.
Detailed description
The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 20 subjects with compulsive sexual behavior.
Interventions
DRUGNaltrexone
daily
DRUGSugar pill
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 diagnosis of compulsive sexual behavior
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 1 month) 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 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; and 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 Compulsive Sexual Behavior (YBOCS) | Assessed at each visit (every two weeks) until participation in the study was done (Week 8) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression Scale - Severity | Assessed at each visit (every two weeks) until participation in the study was done (Week 8) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Naltrexone Naltrexone 50mg-150mg by mouth per day. | 4 |
| Placebo Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician | 3 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
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 | 3 Participants | 4 Participants | 7 Participants |
| Age Continuous | 35.67 years STANDARD_DEVIATION 10.69 | 27.67 years STANDARD_DEVIATION 7.37 | 31.87 years STANDARD_DEVIATION 9.31 |
| Region of Enrollment United States | 3 participants | 4 participants | 7 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 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 | 0 / 4 | 0 / 3 |
| serious Total, serious adverse events | 0 / 4 | 0 / 3 |
Outcome results
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).
Time frame: Assessed at each visit (every two weeks) until participation in the study was done (Week 8)
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 Compulsive Sexual Behavior (YBOCS) | 8 units on a scale | Standard Deviation 7 |
| Placebo | Yale Brown Obsessive Compulsive Scale Modified for Compulsive Sexual Behavior (YBOCS) | 9.33 units on a scale | Standard Deviation 1.15 |
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.
Time frame: Assessed at each visit (every two weeks) until participation in the study was done (Week 8)
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 | Clinical Global Impression Scale - Severity | 2.33 units on a scale | Standard Deviation 1.53 |
| Placebo | Clinical Global Impression Scale - Severity | 2.67 units on a scale | Standard Deviation 0.58 |