Back to resultsNaltrexone in the Treatment of Trichotillomania
Primary Purpose
Trichotillomania
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Naltrexone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Trichotillomania focused on measuring hair pulling
Eligibility Criteria
Inclusion Criteria:
- men and women age 18-75;
- current DSM-IV trichotillomania;
- hair-pulling primarily due to urges/cravings; and 4) pulling is reported as pleasurable the majority of time.
Exclusion Criteria:
- unstable medical illness or clinically significant abnormalities on pre-study laboratory tests or physical examination;
- history of seizures;
- myocardial infarction within 6 months;
- current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
- clinically significant suicidality;
- current or recent (past 3 months) DSM-IV substance abuse or dependence;
- illegal substance within 2 weeks of study initiation;
- initiation of psychotherapy or behavior therapy from a mental health professional for the treatment of trichotillomania within 3 months prior to study baseline;
- initiation of a psychotropic medication within 2 months prior to study inclusion;
- previous treatment with naltrexone; and
- 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;
- lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder;
- current use of opiates.
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Naltrexone
Placebo
Outcomes
Primary Outcome Measures
National Institute of Mental Health Trichotillomania Symptom Severity Scale
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.
Secondary Outcome Measures
Massachusetts General Hospital Hairpulling Scale
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.
Liver Function Tests
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).
Full Information
NCT ID
NCT00775229
First Posted
October 16, 2008
Last Updated
February 21, 2023
Sponsor
University of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT00775229
Brief Title
Naltrexone in the Treatment of Trichotillomania
Official Title
A Double-blind, Placebo-controlled Study of Naltrexone in Trichotillomania
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is an 8-week, double-blind study of Natrexone in the treatment of trichotillomania
Detailed Description
The goal of the proposed study is to evaluate the efficacy of Naltrexone in trichotillomania. Forty subjects with DSM-IV trichotillomania will receive 8 weeks of double-blind Naltrexone or placebo. The hypothesis to be tested is that Naltrexone will be effective and well tolerated in patients with trichotillomania compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichotillomania
Keywords
hair pulling
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Naltrexone
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Other Intervention Name(s)
ReVia
Intervention Description
pill, by mouth, 50mg-150mg/day for the duration of the study
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
also known as a 'sugar pill'
Intervention Description
pill, by mouth, daily
Primary Outcome Measure Information:
Title
National Institute of Mental Health Trichotillomania Symptom Severity Scale
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).
Secondary Outcome Measure Information:
Title
Massachusetts General Hospital Hairpulling Scale
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).
Title
Liver Function Tests
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
men and women age 18-75;
current DSM-IV trichotillomania;
hair-pulling primarily due to urges/cravings; and 4) pulling is reported as pleasurable the majority of time.
Exclusion Criteria:
unstable medical illness or clinically significant abnormalities on pre-study laboratory tests or physical examination;
history of seizures;
myocardial infarction within 6 months;
current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
clinically significant suicidality;
current or recent (past 3 months) DSM-IV substance abuse or dependence;
illegal substance within 2 weeks of study initiation;
initiation of psychotherapy or behavior therapy from a mental health professional for the treatment of trichotillomania within 3 months prior to study baseline;
initiation of a psychotropic medication within 2 months prior to study inclusion;
previous treatment with naltrexone; and
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;
lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder;
current use of opiates.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon E Grant, M.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60615
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34582562
Citation
Hoffman J, Williams T, Rothbart R, Ipser JC, Fineberg N, Chamberlain SR, Stein DJ. Pharmacotherapy for trichotillomania. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD007662. doi: 10.1002/14651858.CD007662.pub3.
Results Reference
derived
PubMed Identifier
23251869
Citation
Odlaug BL, Chamberlain SR, Harvanko AM, Grant JE. Age at onset in trichotillomania:clinical variables and neurocognitive performance. Prim Care Companion CNS Disord. 2012;14(4):PCC.12m01343. doi: 10.4088/PCC.12m01343. Epub 2012 Jul 19.
Results Reference
derived
Learn more about this trial
Naltrexone in the Treatment of Trichotillomania
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