Medical AbortionPhase 4NCT03604341
Cannabinoids for Pain Control During Medical Abortion
A Phase 4 study testing Dronabinol 5mg Cap in people with Medical Abortion and Pain, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 89 years, women only
- Conditions the study is for
- Medical Abortion, Pain
- What is being tested?
- Dronabinol 5mg Cap
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 28 May 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Cannabinoid Analgesia for Medical Abortion: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Medical Abortion, Pain
- Being tested
- Dronabinol 5mg Cap, Placebo
- Keywords
- Medical Abortion, Pain, Cannabis
- Medical subject headings
- Pain, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dronabinol 5mg CapDrug
Also called Dronabinol
Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain
PlaceboOther
Subjects randomized to placebo and ibuprofen 800mg for pain
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours after misoprostol administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start1 Nov 2018
- Primary completion7 May 2019
- Study completion28 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medical AbortionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Principal investigator, Jeffrey Jensen, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604341
- Sponsor's protocol ID
- OHSU IRB 18195
- Status last verified
- Mar 2020
- First submitted
- 19 Jul 2018
- Last updated
- 7 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers or used for future research.
Publications
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.
PubMed 32459420
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabinoid Analgesia for Medical Abortion: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03604341
- Acronym / sponsor ID
- OHSU IRB 18195
- Conditions
- Medical Abortion, Pain
- Keywords
- Medical Abortion, Pain, Cannabis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 7 May 2019 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 27 Jul 2018 (actual)
- Results
- Posted 7 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gestational age up to 10w0d - Dronabinol | Experimental | Drug: Dronabinol 5mg CapWomen with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo |
| Gestational age up to 10w0d - Placebo | Placebo comparator | Other: PlaceboWomen with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dronabinol 5mg CapAlso: DronabinolSubjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain | Drug | Gestational age up to 10w0d - Dronabinol |
| PlaceboSubjects randomized to placebo and ibuprofen 800mg for pain | Other | Gestational age up to 10w0d - Placebo |
Primary outcome
Maximum Self-reported Pain Score on a Numeric Rating Scale
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32459420Colwill 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers or used for future research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dronabinol 5mg Cap in people with Medical Abortion and Pain, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Self-reported Pain Score on a Numeric Rating Scale (time frame: 24 hours after misoprostol administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03604341, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.