Use of N-Acetylcysteine (NAC) in Fingernail Biting

Phase 3

Completed

• Conditions: Onychophagia
• Interventions: Other: Placebo; Drug: N-Acetylcysteine (NAC)

• Registration Number: NCT01993849
• Lead Sponsor: Kevin Gray, MD

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-09-24
• Study Start: 2013-10
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-25
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Results First Submitted: 2018-04-24
• Status Verified: 2018-09
• Results First Submitted QC: 2018-09-07
• Last Update Submitted: 2018-09-07
• Results First Posted: 2018-10-03
• Last Update Posted: 2018-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Oral placebo (matched in appearance to active treatment) twice daily dosing for 8 weeks
N-Acetylcysteine (NAC)	N-Acetylcysteine (NAC)	Oral N-acetylcysteine 1200 mg twice daily dosing for 8 weeks

Primary Outcome Measures

Name	Time	Method
Number of Participants Enrolled Within One Year	1 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.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States