Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dronabinol 5mg Cap | Drug | Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32459420 | Derived | 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. |
Not provided
Not provided
Individual participant data will not be shared with other researchers or used for future research.
Not provided
Not provided
Not provided
Not provided
2 participants failed to meet the inclusion criteria after enrollment and were not assigned to a treatment group.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Gestational Age up to 10w0d - Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | score on a scale | 24 hours after misoprostol administration |
|
from enrollment to 21 days after abortion procedure
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| OB/Gyn Regulatory Specialist | Oregon Health & Science University | 503-494-3666 | whru@ohsu.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2019 | Mar 24, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019966 | Substance-Related Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D013759 | Dronabinol |
| D002214 | Capsules |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Subjects randomized to placebo and ibuprofen 800mg for pain |
|
| Protocol Violation |
|
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 2 |
| 35 |
| EG001 | 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 | 0 | 35 | 0 | 35 | 0 | 35 |
Not provided
Not provided
Not provided
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D004304 |
| Dosage Forms |
| D004364 | Pharmaceutical Preparations |