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Completed

NCT Number: NCT01993849

Use of N-Acetylcysteine (NAC) in Fingernail Biting

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.

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Key information

Conditions

Onychophagia Anxiety Disorders Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Behavior Behavioral Symptoms Depression Habits Mental Disorders Nail Biting Neurodevelopmental Disorders

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N-acetylcysteine (NAC)

Drug

This is the medication N-acetylcysteine (NAC)

Other names: NAC

Placebo

Other

Placebo, designed to match in appearance to NAC

Primary outcomes

  1. Number of Participants Enrolled Within One Year

    Time frame: 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.

Other outcomes

  1. Measurement of Nail Length

    Time frame: End of 8-week treatment

    Length of nails, measured by caliper

Sponsors and collaborators

Lead sponsor

Kevin Gray, MD

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 25, 2013
Registry last updated
Oct 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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