A Randomized Placebo-controlled Trial of N-Acetylcysteine in Onychophagia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Number of Participants Enrolled Within One Year
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fingernail biter for ≥5 years
排除标准
- •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
研究组 & 干预措施
N-Acetylcysteine (NAC)
Oral N-acetylcysteine 1200 mg twice daily dosing for 8 weeks
干预措施: N-Acetylcysteine (NAC) (Drug)
Placebo
Oral placebo (matched in appearance to active treatment) twice daily dosing for 8 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Number of Participants Enrolled Within One Year
时间窗: 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.
次要结局
未报告次要终点
研究者
Kevin Gray, MD
Associate Professor
Medical University of South Carolina