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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

Tracking Information
First Submitted Date  ICMJE September 24, 2013
First Posted Date  ICMJE November 25, 2013
Results First Submitted Date  ICMJE April 24, 2018
Results First Posted Date  ICMJE October 3, 2018
Last Update Posted Date October 3, 2018
Study Start Date  ICMJE October 2013
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 19, 2013)
Feasibility of conducting a trial of NAC in fingernail biters. [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2013)
Changes in rate of fingernail biting [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: September 7, 2018)
Measurement of Nail Length [ Time Frame: End of 8-week treatment ]
Length of nails, measured by caliper
Original Other Pre-specified Outcome Measures
 (submitted: November 19, 2013)
  • Craving for nail biting [ Time Frame: 12 weeks ]
  • Measurement of Nail Length [ Time Frame: 12 weeks ]
 
Descriptive Information
Brief Title  ICMJE Use of N-Acetylcysteine (NAC) in Fingernail Biting
Official Title  ICMJE A Randomized Placebo-controlled Trial of N-Acetylcysteine in Onychophagia
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Onychophagia
Intervention  ICMJE
  • Drug: N-Acetylcysteine (NAC)
    This is the medication N-acetylcysteine (NAC)
    Other Name: NAC
  • Other: Placebo
    Placebo, designed to match in appearance to NAC
Study Arms  ICMJE
  • Active Comparator: N-Acetylcysteine (NAC)
    Oral N-acetylcysteine 1200 mg twice daily dosing for 8 weeks
    Intervention: Drug: N-Acetylcysteine (NAC)
  • Placebo Comparator: Placebo
    Oral placebo (matched in appearance to active treatment) twice daily dosing for 8 weeks
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 7, 2018)
23
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2013)
40
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01993849
Other Study ID Numbers  ICMJE Pro00028506
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kevin Gray, MD, Medical University of South Carolina
Study Sponsor  ICMJE Kevin Gray, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kevin M Gray, MD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP