Portland, Oregon 97239


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Aged 21 years or older - Seeking medical abortion - In good health - Pregnancy with intrauterine gestational sac up to 10 0/7 weeks, dated by ultrasound - Able and willing to receive text messages via phone - Literate in English - 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: - Lack of access to cell phone and texting capabilities - Early pregnancy failure - Contraindications to the study medications: Dronabinol, Ibuprofen - Contraindications to medical abortion with Mifepristone or Misoprostol - History of methadone or heroin use - Used alcohol in the past 24 hours - Used marijuana >4 times per week - Any opioid in the past 30 days - Using additional pain medications


NCT ID:

NCT03604341


Primary Contact:

Women's Health Research Unit Confidential Recruitment Line
Phone: 503-494-3666
Email: whru@ohsu.edu


Backup Contact:

N/A


Location Contact:

Portland, Oregon 97239
United States

Women's Health Research Unit Confidential Recruitment Line
Phone: 503-494-3666
Email: whru@ohsu.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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