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This is a 12-week, double-blind study of N-Acetyl Cysteine in the treatment of trichotillomania
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-Acetyl Cysteine | Active Comparator | N-Acetyl Cysteine |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | daily |
| |
| N-Acetyl Cysteine |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and final visit after 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon E Grant, MD, JD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34582562 | Derived | 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. | |
| 23251869 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | N-Acetyl Cysteine | N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day |
| FG001 | Placebo | Placebo pills |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | N-Acetyl Cysteine | N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day |
| BG001 | Placebo | Placebo pills |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and final visit after 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | N-Acetyl Cysteine | N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jon E. Grant | University of Chicago | 773-834-1325 | jongrant@uchicago.edu |
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| ID | Term |
|---|---|
| D014256 | Trichotillomania |
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D007174 | Disruptive, Impulse Control, and Conduct Disorders |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Drug |
600mg capsules in varying doses for 12 weeks. |
|
|
| 19581567 | Derived | 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. |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo pills
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Placebo | Placebo pills | 0 | 25 | 3 | 25 |
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
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| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |