Use of N-Acetylcysteine (NAC) in Fingernail Biting

September 7, 2018 updated by: Kevin Gray, MD

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of Nail Length
Time Frame: End of 8-week treatment
Length of nails, measured by caliper
End of 8-week treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

September 24, 2013

First Submitted That Met QC Criteria

November 19, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Actual)

October 3, 2018

Last Update Submitted That Met QC Criteria

September 7, 2018

Last Verified

September 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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