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To conduct a pilot randomized placebo-controlled feasibility trial of N-acetylcysteine (NAC) in onychophagia, preliminarily assessing the tolerability and effects of this pharmacotherapy on young adults who bite their fingernails. It is proposed that NAC will help decrease fingernail biting.
This is a proof-of-concept pilot placebo-controlled trial of N-acetylcysteine (NAC) in young people who bite fingernails. The primary interest is in assessing the feasibility of conducting this line of research, while preliminarily exploring potential effects on nail biting, as measured by nail length.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-Acetylcysteine (NAC) | Active Comparator | Oral N-acetylcysteine 1200 mg twice daily dosing for 8 weeks |
|
| Placebo | Placebo Comparator | Oral placebo (matched in appearance to active treatment) twice daily dosing for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-Acetylcysteine (NAC) | Drug | This is the medication N-acetylcysteine (NAC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Enrolled Within One Year | Ability to enroll the goal sample within one year; we are interested in the feasibility of sufficient enrollment and data collection within a given period of time. | 1 year |
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| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Nail Length | Length of nails, measured by caliper | End of 8-week treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin M Gray, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | N-Acetylcysteine | Twice daily dosing for 8 weeks N-Acetylcysteine (NAC) |
| FG001 | Placebo | Twice daily dosing for 8 weeks Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | N-Acetylcysteine (NAC) | 1200 mg twice daily dosing for 8 weeks N-Acetylcysteine (NAC) |
| BG001 | Placebo | Twice daily dosing for 8 weeks Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants Enrolled Within One Year | Ability to enroll the goal sample within one year; we are interested in the feasibility of sufficient enrollment and data collection within a given period of time. | The goal sample was to enroll at least 10 participants per arm/group within the specified recruitment period. | Posted | Count of Participants | Participants | 1 year |
|
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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-Acetylcysteine | 1200 mg twice daily dosing for 8 weeks N-Acetylcysteine (NAC) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin M. Gray, M.D. | Medical University of South Carolina | 843-792-6330 | graykm@musc.edu |
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| ID | Term |
|---|---|
| D009259 | Nail Biting |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D006184 | Habits |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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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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| Placebo | Other | Placebo, designed to match in appearance to NAC |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Other Pre-specified | Measurement of Nail Length | Length of nails, measured by caliper | Posted | Mean | Standard Deviation | millimeters | End of 8-week treatment |
|
|
|
|
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Placebo | Twice daily dosing for 8 weeks Placebo | 0 | 11 | 0 | 11 |
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| D019958 |
| Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |