Use of N-Acetylcysteine (NAC) in Fingernail Biting

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Placebo-controlled Trial of N-Acetylcysteine in Onychophagia

Conditions
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Onychophagia

Intervention / Treatment
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* Drug: N-Acetylcysteine (NAC)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Age 18-30 2. Fingernail biter for ≥5 years Exclusion Criteria: 1. Any unstable major DSM-IV Axis I psychiatric disorder in the past month (e.g., psychotic disorders, bipolar disorder, major depressive disorder) 2. Current substance dependence in the past month 3. Current unstable major medical disorder or medical condition in the past 6 months (e.g., renal impairment) 4. Current pregnancy or breastfeeding 5. Current seizure disorder or asthma, due to possible elevated risk for adverse effects with NAC in individuals with these conditions 6. Known hypersensitivity to NAC 7. Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with NAC) within 14 days of study participation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: N-Acetylcysteine (NAC)<br>Oral N-acetylcysteine 1200 mg twice daily dosing for 8 weeks | Drug: N-Acetylcysteine (NAC)<br>* This is the medication N-acetylcysteine (NAC)<br>* Other names: NAC;|
| Placebo Comparator: Placebo<br>Oral placebo (matched in appearance to active treatment) twice daily dosing for 8 weeks | Other: Placebo<br>* Placebo, designed to match in appearance to NAC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Impulse control, Depression, ADHD, Fingernail Biting, N-Acetylcysteine, NAC