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OpenTrials
Completed

NCT Number: NCT03604341

Cannabinoids for Pain Control During Medical Abortion

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.

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Key information

Age range

21 year–89 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dronabinol 5mg Cap

Drug

Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain

Other names: Dronabinol

Placebo

Other

Subjects randomized to placebo and ibuprofen 800mg for pain

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Society of Family Planning

Registry information

Official study title

Cannabinoid Analgesia for Medical Abortion: A Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 27, 2018
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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