A Randomized Placebo-controlled Trial of N-Acetylcysteine in Onychophagia
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Kevin Gray, MD
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Number of Participants Enrolled Within One Year
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 30 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Fingernail biter for ≥5 years
Exclusion Criteria
- •Any unstable major DSM-IV Axis I psychiatric disorder in the past month (e.g., psychotic disorders, bipolar disorder, major depressive disorder)
- •Current substance dependence in the past month
- •Current unstable major medical disorder or medical condition in the past 6 months (e.g., renal impairment)
- •Current pregnancy or breastfeeding
- •Current seizure disorder or asthma, due to possible elevated risk for adverse effects with NAC in individuals with these conditions
- •Known hypersensitivity to NAC
- •Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with NAC) within 14 days of study participation
Arms & Interventions
N-Acetylcysteine (NAC)
Oral N-acetylcysteine 1200 mg twice daily dosing for 8 weeks
Intervention: N-Acetylcysteine (NAC) (Drug)
Placebo
Oral placebo (matched in appearance to active treatment) twice daily dosing for 8 weeks
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Kevin Gray, MD
Associate Professor
Medical University of South Carolina