Use of N-Acetylcysteine (NAC) in Fingernail Biting

NCT ID: NCT01993849

Last Updated: 2018-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-06-30

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.

Conditions

Onychophagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

N-Acetylcysteine (NAC)

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

Group Type: ACTIVE_COMPARATOR

N-Acetylcysteine (NAC)

Intervention Type: DRUG

This is the medication N-acetylcysteine (NAC)

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo, designed to match in appearance to NAC

Interventions

N-Acetylcysteine (NAC)

This is the medication N-acetylcysteine (NAC)

Intervention Type: DRUG

Placebo

Placebo, designed to match in appearance to NAC

Intervention Type: OTHER

Other Intervention Names

NAC

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kevin Gray, MD

OTHER

Sponsor Role: lead

Responsible Party

Kevin Gray, MD

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kevin M Gray, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

Pro00028506

Identifier Type: -

Identifier Source: org_study_id