Cannabinoids for Pain Control During Medical Abortion

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-05-28

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.

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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.

Conditions

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Medical Abortion Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Dronabinol 5mg Cap

Intervention Type DRUG

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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Subjects randomized to placebo and ibuprofen 800mg for pain

Interventions

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Dronabinol 5mg Cap

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

Intervention Type DRUG

Placebo

Subjects randomized to placebo and ibuprofen 800mg for pain

Intervention Type OTHER

Other Intervention Names

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Dronabinol

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

89 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No