NCT03480009

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

Dextromethorphan as a Novel Non-opioid Adjunctive Agent for Pain Control in Medication Abortion: a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Study Investigator-Sponsor · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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).

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, pain and bleeding are common and expected side effects. Up to a quarter of women rate their pain as severe during their procedure. Pain management for medical abortion is challenging given that the most acute pain occurs at home rather than under the supervision of medical professionals. Currently there is insufficient evidence to recommend an optimal regimen for pain control in medication abortion and there are concerns surrounding narcotic prescribing and the opiate abuse epidemic. This is a four-arm, prospective, double-blind, randomized controlled trial comparing dextromethorphan administration in conjunction with the current standard regimen (NSAIDs and narcotic medication by request- commonly oxycodone or codeine) to the standard regimen alone. Pain will be evaluated by analgesia usage and self-reported pain scores. Investigators will also investigate factors influencing pain and subjective components of the patient narrative. Ideally, a non-opioid adjunct to NSAIDs or narcotics could be used to control pain and significantly curtail or avoid opioid use. Investigators seek to test the efficacy and safety of dextromethorphan as a non-narcotic analgesic for medication abortion.

Conditions

• Abortion in First Trimester

Interventions

Type	Name	Description
DRUG	Dextromethorphan Hydrobromide	Dextromethorphan capsule
DRUG	Avicel PH101 (Microcrystalline Cellulose NF) for Compounding	Placebo capsule
DRUG	Oxycodone	Participants may opt for the narcotic receiving arms of the study, before being randomized to dextromethorphan/placebo.

Timeline

• Start date: 2018-07-28
• Primary completion: 2019-06-30
• Completion: 2019-06-30
• First posted: 2018-03-27
• Last updated: 2020-08-06
• Results posted: 2020-08-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study