Cannabinoids for Pain Control During Medical Abortion

March 24, 2020 updated by: Jeffrey Jensen, Oregon Health and Science University

Cannabinoid Analgesia for Medical Abortion: A Randomized Controlled Trial

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gestational age up to 10w0d - Dronabinol
Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo
Drug: Dronabinol 5mg Cap
Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain
Other Names:
  • Dronabinol
Placebo Comparator: Gestational age up to 10w0d - Placebo
Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo
Other: Placebo
Subjects randomized to placebo and ibuprofen 800mg for pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours after misoprostol administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

Society of Family Planning

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

May 7, 2019

Study Completion (Actual)

May 28, 2019

Study Registration Dates

First Submitted

July 19, 2018

First Submitted That Met QC Criteria

July 19, 2018

First Posted (Actual)

July 27, 2018

Study Record Updates

Last Update Posted (Actual)

April 7, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OHSU IRB 18195

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual participant data will not be shared with other researchers or used for future research.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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