Cannabinoids for Pain Control During Medical Abortion

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cannabinoid Analgesia for Medical Abortion: A Randomized Controlled Trial

Conditions
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Medical Abortion, Pain

Intervention / Treatment
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* Drug: Dronabinol 5mg Cap
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medical Abortion, Pain, Cannabis