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

Study Investigator-Sponsor

Status and phase: Completed; Phase 3

Conditions: Abortion in First Trimester

Treatments: Drug: Oxycodone; Drug: Avicel PH101 (Microcrystalline Cellulose NF) for Compounding; Drug: Dextromethorphan Hydrobromide

Study type: Interventional

Funder types: Other

Identifiers

NCT03480009

STUDY19020221

Details and patient eligibility

About

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).

Full 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.

Enrollment: 156 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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156 participants in 4 patient groups, including a placebo group

Dextromethorphan, opted for narcotic prescription

Experimental group

Description:

Dextromethorphan hydrobromide and patient opts for narcotics (oxycodone or other standard narcotics)

Treatment:

Drug: Dextromethorphan Hydrobromide

Drug: Oxycodone

Placebo, opted for narcotic prescription

Placebo Comparator group

Description:

Avicel PH101 (Microcrystalline Cellulose NF) and patient opts for narcotics (oxycodone or other standard narcotics)

Treatment:

Drug: Avicel PH101 (Microcrystalline Cellulose NF) for Compounding

Drug: Oxycodone

Dextromethorphan, declined narcotic prescription

Experimental group

Description:

Dextromethorphan hydrobromide and patient declines narcotic

Treatment:

Drug: Dextromethorphan Hydrobromide

Placebo, declined narcotic prescription

Placebo Comparator group

Description:

Avicel PH101 (Microcrystalline Cellulose NF) for Compounding and patient declines narcotic

Treatment:

Drug: Avicel PH101 (Microcrystalline Cellulose NF) for Compounding