Cannabinoids for Pain Control During Medical Abortion

Pain Clinical Trial

Official title:

Cannabinoid Analgesia for Medical Abortion: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03604341
• Other study ID #: OHSU IRB 18195
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2018
• Est. completion date: May 28, 2019

Study information

• Verified date: March 2020
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 28, 2019
• Est. primary completion date: May 7, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 89 Years

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.

Related Conditions & MeSH terms

• Medical Abortion
• Pain

Intervention

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

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Self-reported Pain Score on a Numeric Rating Scale	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.	24 hours after misoprostol administration