Cannabinoids for Pain Control During Medical Abortion

NCT03604341 | Completed Phase 4 Results FDA Drug

• 1 other identifier: OHSU IRB 18195
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Medical Abortion; Pain

Keywords

Medical Abortion; Pain; Cannabis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Gestational age up to 10w0d - Dronabinol

EXPERIMENTAL

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

Drug: Dronabinol 5mg Cap

Gestational age up to 10w0d - Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Dronabinol 5mg Cap DRUG

Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain

Also known as: Dronabinol

Gestational age up to 10w0d - Dronabinol

Placebo OTHER

Subjects randomized to placebo and ibuprofen 800mg for pain

Gestational age up to 10w0d - Placebo

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Society of Family Planning: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• 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.

  PMID: 32459420 DERIVED

MeSH Terms

Conditions

Pain; Marijuana Abuse

Interventions

Dronabinol; Capsules

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: OB/Gyn Regulatory Specialist
• Organization: Oregon Health & Science University

whru@ohsu.edu

503-494-3666

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: July 27, 2018
• Study Start: November 1, 2018
• Primary Completion: May 7, 2019
• Study Completion: May 28, 2019
• Last Updated: April 7, 2020
• Results First Posted: April 7, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)