Trial Outcomes & Findings for Double-Blind Naltrexone in Kleptomania (NCT NCT00332579)
NCT ID: NCT00332579
Last Updated: 2019-07-29
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
K-YBOCS is done at each visit by the investigator.
Results posted on
2019-07-29
Participant Flow
Participant milestones
| Measure |
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.
|
Placebo
Placebo tablets (identical to naltrexone pills) taken by mouth daily.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
|
Overall Study
COMPLETED
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Double-Blind Naltrexone in Kleptomania
Baseline characteristics by cohort
| Measure |
Naltrexone
n=12 Participants
Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.
|
Placebo
n=13 Participants
Placebo tablets (identical to naltrexone pills) taken by mouth daily.
|
Total
n=25 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
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 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
|
44.3 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
41.4 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
42.6 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 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
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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).
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).
Outcome measures
| Measure |
Naltrexone
n=12 Participants
Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.
|
Placebo
n=13 Participants
Placebo tablets (identical to naltrexone pills) taken by mouth daily.
|
|---|---|---|
|
Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS)
|
3.83 units on a scale
Standard Deviation 2.86
|
11.46 units on a scale
Standard Deviation 7.76
|
Adverse Events
Naltrexone
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Naltrexone
n=13 participants at risk
Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.
|
Placebo
n=12 participants at risk
Placebo tablets (identical to naltrexone pills) taken by mouth daily.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
23.1%
3/13 • Number of events 3
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Insomnia
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Dry Mouth
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Headache
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place