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. 2022 May 13;2022(5):CD013525. doi: 10.1002/14651858.CD013525.pub2

NCT03604341.

Methods "Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment"
Participants "Inclusion Criteria:
  • 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


Exclusion Criteria:
  • 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"

Interventions "Drug: Dronabinol 5mg Cap
Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain
Other Name: Dronabinol
  • Other: Placebo


Subjects randomized to placebo and ibuprofen 800mg for pain"
Outcomes "Maximum Self‐reported Pain Score on a Numeric Rating Scale [ Time Frame: 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."
Notes