Onychophagia
Conditions
Keywords
Anxiety, Impulse control, Depression, ADHD, Fingernail Biting, N-Acetylcysteine, NAC
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.
Interventions
DRUGN-Acetylcysteine (NAC)
This is the medication N-acetylcysteine (NAC)
OTHERPlacebo
Placebo, designed to match in appearance to NAC
Sponsors
Kevin Gray, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Enrolled Within One Year | 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
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Nail Length | End of 8-week treatment | Length of nails, measured by caliper |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| N-Acetylcysteine (NAC) 1200 mg twice daily dosing for 8 weeks
N-Acetylcysteine (NAC) | 12 |
| Placebo Twice daily dosing for 8 weeks
Placebo | 11 |
| Total | 23 |
Baseline characteristics
| Characteristic | N-Acetylcysteine (NAC) | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 26.7 years STANDARD_DEVIATION 5.2 | 27.4 years STANDARD_DEVIATION 4.7 | 27.0 years STANDARD_DEVIATION 4.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 9 Participants | 17 Participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 12 | 0 / 11 |
| serious Total, serious adverse events | 0 / 12 | 0 / 11 |
Outcome results
Primary
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.
Time frame: 1 year
Population: The goal sample was to enroll at least 10 participants per arm/group within the specified recruitment period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| N-Acetylcysteine (NAC) | Number of Participants Enrolled Within One Year | 12 Participants |
| Placebo | Number of Participants Enrolled Within One Year | 11 Participants |
Other Pre-specified
Measurement of Nail Length
Length of nails, measured by caliper
Time frame: End of 8-week treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| N-Acetylcysteine (NAC) | Measurement of Nail Length | 10.12 millimeters | Standard Deviation 2.43 |
| Placebo | Measurement of Nail Length | 10.73 millimeters | Standard Deviation 3.4 |
p-value: 0.6995% CI: [-3.81, 2.59]t-test, 2 sided