Cannabinoid Analgesia for Medical Abortion: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Maximum Self-reported Pain Score on a Numeric Rating Scale
研究概览
简要总结
The objective of this study is to determine if a synthetic cannabis derivative, dronabinol, in addition to ibuprofen, decreases maximum pain scores compared to ibuprofen and placebo in women undergoing medical abortion. Results of this study will help providers counsel patients regarding cannabis use during medical abortion.
详细描述
This is a randomized, double-blind, placebo-controlled trial comparing pain levels in women undergoing medical abortion with one of two regimens: ibuprofen 800mg and a 5mg oral dronabinol versus ibuprofen 800mg and placebo given at the time of misoprostol administration. This study will include 62 women undergoing medical abortion. Women will be randomized to dronabinol 5mg oral versus placebo. The primary outcome will be maximum reported pain score within 24 hours of misoprostol administration.
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
- 21 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 21 years or older
- •Consented for elective medical abortion
- •Pregnancy with intrauterine gestational sac up to 10 0/7 weeks, dated by ultrasound
- •Able and willing to receive text messages via phone
- •English speaking
- •Able and willing to give informed consent and agree to the study terms
- •Have assistance at home; no motor vehicle use while taking study medications
排除标准
- •Desires to continue pregnancy or currently breastfeeding
- •Lack of access to cell phone and texting capabilities
- •Prior participation in this study
- •Early pregnancy failure
- •Contraindications to the study medications: Marinol or marijuana derivatives, sesame oil, Ibuprofen
- •Contraindications to medical abortion with Mifepristone or Misoprostol
- •History of methadone, buprenorphine or heroin use within the last year
- •History of a seizure disorder
- •Used marijuana 5 or more days in the last week
- •History of any adverse effects associated with prior use of recreational or medical marijuana products, or sensitivity/allergy to Marinol.
研究组 & 干预措施
Gestational age up to 10w0d - Dronabinol
Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo
干预措施: Dronabinol 5mg Cap (Drug)
Gestational age up to 10w0d - Placebo
Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo
干预措施: Placebo (Other)
结局指标
主要结局
Maximum Self-reported Pain Score on a Numeric Rating Scale
时间窗: 24 hours after misoprostol administration
Women will text responds to surveys within 24 hours after misoprostol administration indicating their maximum self-reported pain using an 11-point numeric rating scale (NRS 0-10) where 0=no pain and 10=worst possible pain.
次要结局
未报告次要终点
研究者
Jeffrey Jensen
Principal Investigator
Oregon Health and Science University