Use of N-Acetylcysteine (NAC) in Fingernail Biting

NCT01993849 | Completed Phase 3 Results

• 1 other identifier: Pro00028506
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Onychophagia

Keywords

Anxiety; Impulse control; Depression; ADHD; Fingernail Biting; N-Acetylcysteine; NAC

Outcome Measures

Primary Outcomes (1)

• Number of Participants Enrolled Within One 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 Outcomes (1)

• Measurement of Nail Length

  End of 8-week treatment

Study Arms (2)

N-Acetylcysteine (NAC)

ACTIVE COMPARATOR

Oral N-acetylcysteine 1200 mg twice daily dosing for 8 weeks

Drug: N-Acetylcysteine (NAC)

Placebo

PLACEBO COMPARATOR

Oral placebo (matched in appearance to active treatment) twice daily dosing for 8 weeks

Other: Placebo

Interventions

N-Acetylcysteine (NAC) DRUG

This is the medication N-acetylcysteine (NAC)

Also known as: NAC

N-Acetylcysteine (NAC)

Placebo OTHER

Placebo, designed to match in appearance to NAC

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Age 18-30 2. Fingernail biter for ≥5 years

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Kevin Gray, MD: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Nail Biting; Anxiety Disorders; Depression; Attention Deficit Disorder with Hyperactivity

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Habits; Behavior; Mental Disorders; Behavioral Symptoms; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Kevin M. Gray, M.D.
• Organization: Medical University of South Carolina

graykm@musc.edu

843-792-6330

Study Officials

• Kevin M Gray, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: November 25, 2013
• Study Start: October 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 3, 2018
• Results First Posted: October 3, 2018

Record last verified: 2018-09

Locations

US (1)