Dextromethorphan as a Novel Non-opioid Adjunctive Agent for Pain Control in Medication Abortion

Completed · Phase 3 · Has a placebo group

Conditions studied: Abortion in First Trimester

In brief

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 women over a period of 9-12 months: Receiving narcotics+dextromethorphan, narcotics and placebo (microcrystalline cellulose), no narcotics and dextromethorphan and no narcotics and placebo (microcrystalline cellulose).

Key facts

Study ID

NCT03480009

Run by

Study Investigator-Sponsor

People needed

156

Starts

2018-07-28

Expected to finish

2019-06-30

Last updated by the study team

2020-08-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Center for Family Planning Research, Magee-Womens Hospital — Pittsburgh, Pennsylvania, United States
• Planned Parenthood of Western Pennsylvania — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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