NCT03604341

Cannabinoids for Pain Control During Medical Abortion

Cannabinoid Analgesia for Medical Abortion: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: Female
• Age: 21 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Medical Abortion
• Pain

Interventions

Type	Name	Description
DRUG	Dronabinol 5mg Cap	Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain
OTHER	Placebo	Subjects randomized to placebo and ibuprofen 800mg for pain

Timeline

• Start date: 2018-11-01
• Primary completion: 2019-05-07
• Completion: 2019-05-28
• First posted: 2018-07-27
• Last updated: 2020-04-07
• Results posted: 2020-04-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study