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Naltrexone in the Treatment of Trichotillomania

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00775229
Recruitment Status : Completed
First Posted : October 20, 2008
Results First Posted : March 17, 2014
Last Update Posted : March 17, 2014
Sponsor:
Information provided by (Responsible Party):
Jon Grant, University of Minnesota

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Trichotillomania
Interventions Drug: Naltrexone
Drug: Placebo
Enrollment 51
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description

Naltrexone

Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study

Placebo

Placebo : pill, by mouth, daily

Period Title: Overall Study
Started 25 26
Completed 20 24
Not Completed 5 2
Arm/Group Title Naltrexone Placebo Total
Hide Arm/Group Description

Naltrexone

Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study

Placebo

Placebo : pill, by mouth, daily

Total of all reporting groups
Overall Number of Baseline Participants 25 26 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 26 participants 51 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
 100.0%
26
 100.0%
51
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 26 participants 51 participants
32.2  (9.4) 34.0  (10.1) 32.7  (7.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 26 participants 51 participants
Female
22
  88.0%
22
  84.6%
44
  86.3%
Male
3
  12.0%
4
  15.4%
7
  13.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 26 participants 51 participants
25 26 51
1.Primary Outcome
Title National Institute of Mental Health Trichotillomania Symptom Severity Scale
Hide Description 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.
Time Frame This is the final score, measured at week 8 (final visit).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description:

Naltrexone

Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study

Placebo

Placebo : pill, by mouth, daily

Overall Number of Participants Analyzed 25 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.94  (4.835) 8.73  (5.481)
2.Secondary Outcome
Title Massachusetts General Hospital Hairpulling Scale
Hide Description 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.
Time Frame This is the final score, measured at week 8 (final visit).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description:

Naltrexone

Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study

Placebo

Placebo : pill, by mouth, daily

Overall Number of Participants Analyzed 25 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.21  (6.203) 13.35  (4.749)
3.Secondary Outcome
Title Liver Function Tests
Hide Description 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).
Time Frame Week 8 (last visit)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description:

Naltrexone

Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study

Placebo

Placebo : pill, by mouth, daily

Overall Number of Participants Analyzed 25 26
Measure Type: Number
Unit of Measure: percentage of individuals with LFT chang
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description

Naltrexone

Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study

Placebo

Placebo : pill, by mouth, daily

All-Cause Mortality
Naltrexone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Naltrexone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/26 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Naltrexone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/25 (12.00%)      1/26 (3.85%)    
Psychiatric disorders     
Sedation  3/25 (12.00%)  3 1/26 (3.85%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jon Grant
Organization: University of Chicago
Phone: 773-834-1325
EMail: jongrant@uchicago.edu
Layout table for additonal information
Responsible Party: Jon Grant, University of Minnesota
ClinicalTrials.gov Identifier: NCT00775229    
Other Study ID Numbers: 0806M36061
First Submitted: October 16, 2008
First Posted: October 20, 2008
Results First Submitted: October 9, 2013
Results First Posted: March 17, 2014
Last Update Posted: March 17, 2014