Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of N-Acetylcysteine (NAC) in Fingernail Biting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01993849
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : October 3, 2018
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Kevin Gray, MD, Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Onychophagia Drug: N-Acetylcysteine (NAC) Other: Placebo Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Placebo-controlled Trial of N-Acetylcysteine in Onychophagia
Study Start Date : October 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: N-Acetylcysteine (NAC)
Oral N-acetylcysteine 1200 mg twice daily dosing for 8 weeks
Drug: N-Acetylcysteine (NAC)
This is the medication N-acetylcysteine (NAC)
Other Name: NAC

Placebo Comparator: Placebo
Oral placebo (matched in appearance to active treatment) twice daily dosing for 8 weeks
Other: Placebo
Placebo, designed to match in appearance to NAC




Primary Outcome Measures :
  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 Outcome Measures:
  1. Measurement of Nail Length [ Time Frame: End of 8-week treatment ]
    Length of nails, measured by caliper



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993849


Locations
Layout table for location information
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Kevin Gray, MD
Investigators
Layout table for investigator information
Principal Investigator: Kevin M Gray, MD Medical University of South Carolina

Layout table for additonal information
Responsible Party: Kevin Gray, MD, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01993849     History of Changes
Other Study ID Numbers: Pro00028506
First Posted: November 25, 2013    Key Record Dates
Results First Posted: October 3, 2018
Last Update Posted: October 3, 2018
Last Verified: September 2018

Keywords provided by Kevin Gray, MD, Medical University of South Carolina:
Anxiety
Impulse control
Depression
ADHD
Fingernail Biting
N-Acetylcysteine
NAC

Additional relevant MeSH terms:
Layout table for MeSH terms
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes