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This is an 8-week, double-blind study of Natrexone in the treatment of trichotillomania
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Naltrexone |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone | Drug | pill, by mouth, 50mg-150mg/day for the duration of the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | This is the final score, measured at week 8 (final visit). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | This is the final score, measured at week 8 (final visit). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon E Grant, M.D. | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60615 | 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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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Naltrexone | Naltrexone Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study |
| FG001 | Placebo | Placebo Placebo : pill, by mouth, daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Naltrexone | Naltrexone Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study |
| BG001 | Placebo | Placebo Placebo : pill, by mouth, daily |
| 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 | 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. | Posted | Mean | Standard Deviation | units on a scale | This is the final score, measured at week 8 (final visit). |
|
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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 | Naltrexone | Naltrexone Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sedation | Psychiatric disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jon 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 |
|---|---|
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| Placebo | Drug | pill, by mouth, daily |
|
|
| 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). |
| Week 8 (last visit) |
| 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 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | This is the final score, measured at week 8 (final visit). |
|
|
|
| Secondary | 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). | Posted | Number | percentage of individuals with LFT chang | Week 8 (last visit) |
|
|
|
| 0 |
| 25 |
| 3 |
| 25 |
| EG001 | Placebo | Placebo Placebo : pill, by mouth, daily | 0 | 26 | 1 | 26 |
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| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |