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Cannabinoids for Pain Control During Medical Abortion

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ClinicalTrials.gov Identifier: NCT03604341
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : December 6, 2018
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Katie Alton, MD, Oregon Health and Science University

Brief 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.

Condition or disease Intervention/treatment Phase
Medical Abortion Pain Drug: Dronabinol 5mg Cap Other: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Cannabinoid Analgesia for Medical Abortion: A Randomized Controlled Trial
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol

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 Name: 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




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03604341


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

Locations
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United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Women's Health Research Unit Confidential Recruitment Line    503-494-3666    whru@ohsu.edu   
Sponsors and Collaborators
Oregon Health and Science University
Society of Family Planning

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Responsible Party: Katie Alton, MD, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03604341     History of Changes
Other Study ID Numbers: OHSU IRB 18195
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared with other researchers or used for future research.

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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

Keywords provided by Katie Alton, MD, Oregon Health and Science University:
Medical Abortion
Pain
Cannabis

Additional relevant MeSH terms:
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Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists