Phase 4 N=70 Randomized Double-blind Treatment

Cannabinoids for Pain Control During Medical Abortion

Medical Abortion · Pain

Bottom Line

View on ClinicalTrials.gov: NCT03604341 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2020

Primary outcome: Primary: Maximum Self-reported Pain Score on a Numeric Rating Scale — 7; 7 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Dronabinol 5mg Cap (Drug); Placebo (Other)
Age: Adult, Older Adult · 21+ yrs
Sex: Female
Sponsor: Oregon Health and Science University
Primary completion: May 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Self-reported Pain Score on a Numeric Rating Scale	7; 7	—

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03604341). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.