Medical Abortion, Pain
Conditions
Keywords
Medical Abortion, Pain, Cannabis
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.
Interventions
Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain
OTHERPlacebo
Subjects randomized to placebo and ibuprofen 800mg for pain
Sponsors
Society of Family Planning
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 89 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Self-reported Pain Score on a Numeric Rating Scale | 24 hours after misoprostol administration | 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. |
Countries
United States
Participant flow
Pre-assignment details
2 participants failed to meet the inclusion criteria after enrollment and were not assigned to a treatment group.
Participants by arm
| Arm | Count |
|---|---|
| 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
Dronabinol 5mg Cap: Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain | 35 |
| 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
Placebo: Subjects randomized to placebo and ibuprofen 800mg for pain | 35 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Gestational Age up to 10w0d - Dronabinol | Gestational Age up to 10w0d - Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 35 Participants | 70 Participants |
| Age, Continuous | 28.1 years STANDARD_DEVIATION 6.5 | 28.6 years STANDARD_DEVIATION 5 | 28.3 years STANDARD_DEVIATION 5.8 |
| Race/Ethnicity, Customized Other | 15 Participants | 13 Participants | 28 Participants |
| Race/Ethnicity, Customized White/Non-Hispanic | 20 Participants | 22 Participants | 42 Participants |
| Region of Enrollment United States | 35 Participants | 35 Participants | 70 Participants |
| Sex: Female, Male Female | 35 Participants | 35 Participants | 70 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 2 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
Primary
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.
Time frame: 24 hours after misoprostol administration
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gestational Age up to 10w0d - Dronabinol | Maximum Self-reported Pain Score on a Numeric Rating Scale | 7 score on a scale |
| Gestational Age up to 10w0d - Placebo | Maximum Self-reported Pain Score on a Numeric Rating Scale | 7 score on a scale |