Cannabinoids for Pain Control During Medical Abortion

Phase 4

Completed

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Gestational age up to 10w0d - Dronabinol	Dronabinol 5mg Cap	Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo
Gestational age up to 10w0d - Placebo	Placebo	Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo

Primary Outcome Measures

Name	Time	Method
Maximum Self-reported Pain Score on a Numeric Rating Scale	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.

Secondary Outcome Measures