Cannabinoids for Pain Control During Medical Abortion

Oregon Health & Science University (OHSU)

Status and phase: Completed; Phase 4

Conditions: Medical Abortion; Pain

Treatments: Drug: Dronabinol 5mg Cap; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03604341

OHSU IRB 18195

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: Female

Ages: 21 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups, including a placebo group

Gestational age up to 10w0d - Dronabinol

Experimental group

Description:

Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo

Treatment:

Drug: Dronabinol 5mg Cap

Gestational age up to 10w0d - Placebo

Placebo Comparator group

Description:

Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo

Treatment:

Other: Placebo