Clinical trial NCT03604341: Cannabinoids for Pain Control During Medical Abortion
Official title: Cannabinoid Analgesia for Medical Abortion: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Medical Abortion
Pain
Keywords: Medical Abortion
Pain
Cannabis
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2018-07-27
Enrollment: 72
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Self-reported Pain Score on a Numeric Rating Scale
timeFrame: 24 hours after misoprostol administration
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References:
citation: Colwill AC, Alton K, Bednarek PH, Bayer LL, Jensen JT, Garg B, Beardsworth K, Edelman A. Cannabinoids for Pain Control During Medical Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2020 Jun;135(6):1289-1295. doi: 10.1097/AOG.0000000000003850.