Dronabinol 5mg Cap
Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain
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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2020-04-07
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
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.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain
DronabinolSubjects randomized to placebo and ibuprofen 800mg for pain
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Gestational Age up to 10w0d - Dronabinol | 33 | 7 | 6 to 8 |
| Gestational Age up to 10w0d - Placebo | 33 | 7 | 5 to 8 |
2 participants failed to meet the inclusion criteria after enrollment and were not assigned to a treatment group.
| Milestone | Gestational Age up to 10w0d - Dronabinol | Gestational Age up to 10w0d - Placebo |
|---|---|---|
| STARTED | 35 | 35 |
| COMPLETED | 33 | 33 |
| NOT COMPLETED | 2 | 2 |
Eligibility
primary outcomes
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.
Publications
No exact PMID-linked public article is currently readable locally.
| Event | System | Groups: affected / at risk |
|---|---|---|
| Nausea | Gastrointestinal disorders | Gestational Age up to 10w0d - Dronabinol: 2 / 35 · Gestational Age up to 10w0d - Placebo: 0 / 35 |