Trial Outcomes & Findings for Double-Blind Naltrexone in Compulsive Sexual Behavior (NCT NCT00467558)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Assessed at each visit (every two weeks) until participation in the study was done (Week 8)

Results posted on

2012-05-18

Participant Flow

Participant milestones

Participant milestones
Measure	Naltrexone Naltrexone 50mg-150mg by mouth per day.	Placebo Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
Overall Study STARTED	4	3
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Naltrexone Naltrexone 50mg-150mg by mouth per day.	Placebo Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
Overall Study Lost to Follow-up	2	0

Baseline Characteristics

Double-Blind Naltrexone in Compulsive Sexual Behavior

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Naltrexone n=4 Participants Naltrexone 50mg-150mg by mouth per day.	Placebo n=3 Participants Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	27.67 years STANDARD_DEVIATION 7.37 • n=5 Participants	35.67 years STANDARD_DEVIATION 10.69 • n=7 Participants	31.87 years STANDARD_DEVIATION 9.31 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

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).

Outcome measures

Outcome measures
Measure	Naltrexone n=3 Participants Naltrexone 50mg-150mg by mouth per day.	Placebo n=3 Participants Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
Yale Brown Obsessive Compulsive Scale Modified for Compulsive Sexual Behavior (YBOCS)	8 units on a scale Standard Deviation 7	9.33 units on a scale Standard Deviation 1.15

SECONDARY outcome

Timeframe: 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).

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."

Outcome measures

Outcome measures
Measure	Naltrexone n=3 Participants Naltrexone 50mg-150mg by mouth per day.	Placebo n=3 Participants Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
Clinical Global Impression Scale - Severity	2.33 units on a scale Standard Deviation 1.53	2.67 units on a scale Standard Deviation 0.58

Adverse Events

Naltrexone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jon E. Grant, MD

University of Minnesota

Phone: 612-273-9736

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place