Trial Outcomes & Findings for Naltrexone in the Treatment of Trichotillomania (NCT NCT00775229)

Results Overview

Ranges from 0-20 with 20 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 8 weeks. The final total score is reported here.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

51 participants

Primary outcome timeframe

This is the final score, measured at week 8 (final visit).

Results posted on

2023-02-23

Participant Flow

Men and women aged 18 to 75 years with a primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of TTM were recruited through newspaper advertisements and referrals.

Exclusion: unstable medical illness, current pregnancy or inadequate contraception, thoughts of suicide,history of bipolar disorder,dementia, or psychotic disorder,past 12 months SUD, previous treatment with naltrexone, initiation of behavior therapy within the last 6 months, initiation of a psychotropic medication within the last 3months, opiates.

Participant milestones

Participant milestones
Measure	Naltrexone Naltrexone Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study	Placebo Placebo Placebo : pill, by mouth, daily
Overall Study STARTED	25	26
Overall Study COMPLETED	20	24
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Naltrexone in the Treatment of Trichotillomania

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Naltrexone n=25 Participants Naltrexone Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study	Placebo n=26 Participants Placebo Placebo : pill, by mouth, daily	Total n=51 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	25 Participants n=5 Participants	26 Participants n=7 Participants	51 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	32.2 years STANDARD_DEVIATION 9.4 • n=5 Participants	34.0 years STANDARD_DEVIATION 10.1 • n=7 Participants	32.7 years STANDARD_DEVIATION 7.2 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	22 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	26 participants n=7 Participants	51 participants n=5 Participants

PRIMARY outcome

Timeframe: This is the final score, measured at week 8 (final visit).

Ranges from 0-20 with 20 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 8 weeks. The final total score is reported here.

Outcome measures

Outcome measures
Measure	Naltrexone n=25 Participants Naltrexone Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study	Placebo n=26 Participants Placebo Placebo : pill, by mouth, daily
National Institute of Mental Health Trichotillomania Symptom Severity Scale	7.94 units on a scale Standard Deviation 4.835	8.73 units on a scale Standard Deviation 5.481

SECONDARY outcome

Timeframe: This is the final score, measured at week 8 (final visit).

Ranges from 0-28 with 28 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 8 weeks. The final total score is reported here.

Outcome measures

Outcome measures
Measure	Naltrexone n=25 Participants Naltrexone Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study	Placebo n=26 Participants Placebo Placebo : pill, by mouth, daily
Massachusetts General Hospital Hairpulling Scale	12.21 units on a scale Standard Deviation 6.203	13.35 units on a scale Standard Deviation 4.749

SECONDARY outcome

Timeframe: Week 8 (last visit)

Participants were administered a general test of liver functioning to asses safety over the course of the study. Data represent the percentage of participates with Liver Function Test values falling outside of the range considered safe/typical for liver functioning at any of the assessed time points. It was performed at baseline and at each visit where dosage of the medication is \>50mg/day (week 2-week 8).

Outcome measures

Outcome measures
Measure	Naltrexone n=25 Participants Naltrexone Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study	Placebo n=26 Participants Placebo Placebo : pill, by mouth, daily
Liver Function Tests	0 percentage of individuals with LFT chang	0 percentage of individuals with LFT chang

Adverse Events

Naltrexone

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Naltrexone n=25 participants at risk Naltrexone Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study	Placebo n=26 participants at risk Placebo Placebo : pill, by mouth, daily
Psychiatric disorders Sedation	12.0% 3/25 • Number of events 3	3.8% 1/26 • Number of events 1

Additional Information

Dr. Jon Grant

University of Chicago

Phone: 773-834-1325

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place