Back to resultsN-Acetyl Cysteine in Trichotillomania
Primary Purpose
Trichotillomania
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
N-Acetyl Cysteine
Sponsored by
About this trial
This is an interventional treatment trial for Trichotillomania focused on measuring Trichotillomania, Hair-pulling
Eligibility Criteria
Inclusion Criteria: men and women age 18-65; current DSM-IV trichotillomania Exclusion Criteria: unstable medical illness; history of seizures; myocardial infarction within 6 months; current pregnancy or lactation, or inadequate contraception in women of childbearing potential; any thoughts of suicide; lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder; previous treatment with N-Acetyl Cysteine; 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; 9) diagnosis of asthma
Sites / Locations
- University of Chicago Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
N-Acetyl Cysteine
2
Arm Description
N-Acetyl Cysteine
Placebo
Outcomes
Primary Outcome Measures
Massachusetts General Hospital Hairpulling Scale
There is no minimum or maximum score to quantify 'good' or 'poor' improvement based on this scale. The total score can range from 0-28 with zero being no problems to 28 being the most severe score one can receive.A total of 6 assessments were made, however only the final score (the score at the final visit after 12 weeks) was reported here to show the final outcome measure that was used in the final report of possible improvement and what was reported for final publication of data.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00354770
Brief Title
N-Acetyl Cysteine in Trichotillomania
Official Title
A Double-Blind, Placebo-Controlled Study of N-Acetyl Cysteine in Trichotillomania
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (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 a 12-week, double-blind study of N-Acetyl Cysteine in the treatment of trichotillomania
Detailed Description
The goal of the proposed study is to evaluate the efficacy and safety of N-Acetyl Cysteine (NAC) in trichotillomania. Forty subjects with DSM-IV trichotillomania will receive 12 weeks of double-blind NAC or placebo. The hypothesis to be tested is that NAC 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
Trichotillomania, Hair-pulling
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
N-Acetyl Cysteine
Arm Type
Active Comparator
Arm Description
N-Acetyl Cysteine
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
daily
Intervention Type
Drug
Intervention Name(s)
N-Acetyl Cysteine
Other Intervention Name(s)
NAC
Intervention Description
600mg capsules in varying doses for 12 weeks.
Primary Outcome Measure Information:
Title
Massachusetts General Hospital Hairpulling Scale
Description
There is no minimum or maximum score to quantify 'good' or 'poor' improvement based on this scale. The total score can range from 0-28 with zero being no problems to 28 being the most severe score one can receive.A total of 6 assessments were made, however only the final score (the score at the final visit after 12 weeks) was reported here to show the final outcome measure that was used in the final report of possible improvement and what was reported for final publication of data.
Time Frame
Baseline and final visit after 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
men and women age 18-65;
current DSM-IV trichotillomania
Exclusion Criteria:
unstable medical illness;
history of seizures;
myocardial infarction within 6 months;
current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
any thoughts of suicide;
lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder;
previous treatment with N-Acetyl Cysteine;
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;
9) diagnosis of asthma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon E Grant, MD, JD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
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
PubMed Identifier
19581567
Citation
Grant JE, Odlaug BL, Kim SW. N-acetylcysteine, a glutamate modulator, in the treatment of trichotillomania: a double-blind, placebo-controlled study. Arch Gen Psychiatry. 2009 Jul;66(7):756-63. doi: 10.1001/archgenpsychiatry.2009.60.
Results Reference
derived
Learn more about this trial
N-Acetyl Cysteine in Trichotillomania
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