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

• Status: Completed
• Trial end date: 2019-06-30
• Target enrollment: 0
• Participant gender: Female

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 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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Study Investigator-Sponsor; Study Sponsor-Investigator
• Collaborator: Society of Family Planning
• Treatments: Analgesics, Non-Narcotic; Dextromethorphan; Narcotics; Oxycodone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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