Status:
COMPLETED
Dextromethorphan as a Novel Non-opioid Adjunctive Agent for Pain Control in Medication Abortion
Lead Sponsor:
Study Investigator-Sponsor
Collaborating Sponsors:
Society of Family Planning
Conditions:
Abortion in First Trimester
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This study evaluates dextromethorphan as a non-opioid adjunctive medication for pain control during medication abortion. This is double-blinded, four-arm randomized controlled trial enrolling 156 wome...
Detailed Description
Medication abortion using mifepristone and misoprostol is common, accounting for nearly one-third of abortions in the United States in 2014. Although women generally tolerate medical abortion well, pa...
Eligibility Criteria
Inclusion
- Women aged 18 and over
- Willing to give voluntary consent
- English-speaking
- Eligible for medication abortion per Planned Parenthood of Western Pennsylvania protocol
- Self-reported reliable cellular phone access for the duration of study participation
- Able to receive and reply to a "test" text at time of consent
- Willing to comply with the study protocol
Exclusion
- Use of selective serotonin reuptake inhibitors or monoamine oxidase inhibitors due to risk of Serotonin Syndrome
- Allergy to any component of the medication abortion regimen or study drug
- Has any other condition that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, complicate the interpretation of the study outcome data, or otherwise interfere with achieving the study objectives
- Anticipated use of dextromethorphan during study period
Key Trial Info
Start Date :
July 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT03480009
Start Date
July 28 2018
End Date
June 30 2019
Last Update
August 6 2020
Active Locations (2)
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1
Center for Family Planning Research, Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
2
Planned Parenthood of Western Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213