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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-28

Study Completion Date

2019-06-30

Brief Summary

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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).

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Detailed Description

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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

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Abortion in First Trimester

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dextromethorphan, opted for narcotic prescription

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

Group Type EXPERIMENTAL

Dextromethorphan Hydrobromide

Intervention Type DRUG

Dextromethorphan capsule

Oxycodone

Intervention Type DRUG

Participants may opt for the narcotic receiving arms of the study, before being randomized to dextromethorphan/placebo.

Placebo, opted for narcotic prescription

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

Group Type PLACEBO_COMPARATOR

Avicel PH101 (Microcrystalline Cellulose NF) for Compounding

Intervention Type DRUG

Placebo capsule

Oxycodone

Intervention Type DRUG

Participants may opt for the narcotic receiving arms of the study, before being randomized to dextromethorphan/placebo.

Dextromethorphan, declined narcotic prescription

Dextromethorphan hydrobromide and patient declines narcotic

Group Type EXPERIMENTAL

Dextromethorphan Hydrobromide

Intervention Type DRUG

Dextromethorphan capsule

Placebo, declined narcotic prescription

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

Group Type PLACEBO_COMPARATOR

Avicel PH101 (Microcrystalline Cellulose NF) for Compounding

Intervention Type DRUG

Placebo capsule

Interventions

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Dextromethorphan Hydrobromide

Dextromethorphan capsule

Intervention Type DRUG

Avicel PH101 (Microcrystalline Cellulose NF) for Compounding

Placebo capsule

Intervention Type DRUG

Oxycodone

Participants may opt for the narcotic receiving arms of the study, before being randomized to dextromethorphan/placebo.

Intervention Type DRUG

Other Intervention Names

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Robitussin, Delsym Avicel Tylox, Percodan, OxyContin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes