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

July 23, 2020 updated by: Study Investigator-Sponsor

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Center for Family Planning Research, Magee-Womens Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • Planned Parenthood of Western Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dextromethorphan, opted for narcotic prescription
Dextromethorphan hydrobromide and patient opts for narcotics (oxycodone or other standard narcotics)
Drug: Dextromethorphan Hydrobromide
Dextromethorphan capsule
Other Names:
  • Robitussin, Delsym
Drug: Oxycodone
Participants may opt for the narcotic receiving arms of the study, before being randomized to dextromethorphan/placebo.
Other Names:
  • Tylox, Percodan, OxyContin
Placebo Comparator: Placebo, opted for narcotic prescription
Avicel PH101 (Microcrystalline Cellulose NF) and patient opts for narcotics (oxycodone or other standard narcotics)
Drug: Oxycodone
Participants may opt for the narcotic receiving arms of the study, before being randomized to dextromethorphan/placebo.
Other Names:
  • Tylox, Percodan, OxyContin
Drug: Avicel PH101 (Microcrystalline Cellulose NF) for Compounding
Placebo capsule
Other Names:
  • Avicel
Experimental: Dextromethorphan, declined narcotic prescription
Dextromethorphan hydrobromide and patient declines narcotic
Drug: Dextromethorphan Hydrobromide
Dextromethorphan capsule
Other Names:
  • Robitussin, Delsym
Placebo Comparator: Placebo, declined narcotic prescription
Avicel PH101 (Microcrystalline Cellulose NF) for Compounding and patient declines narcotic
Drug: Avicel PH101 (Microcrystalline Cellulose NF) for Compounding
Placebo capsule
Other Names:
  • Avicel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Worst Pain Measurement Via Numeric Rating Scale (NRS-11)
Time Frame: Over 24 hours starting from misoprostol administration
Self-reported pain measurement via text-messaging system during first 24 hours after misoprostol administration. The scale is from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain possible".
Over 24 hours starting from misoprostol administration
Analgesic Usage During Medication Abortion
Time Frame: Over 24 hours
Analgesic usage by study arm for women who received dextromethorphan vs. placebo as adjunct to routine pain management during medication abortion; missing data are for participants who did not take the specified pain medication.
Over 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Pain Scores Via Numeric Rating Scale (NRS-11)
Time Frame: Marginal mean pain scores over 24 hours
Marginal mean pain scores via Numeric Rating Scale (NRS-11) over 24 hours. The scale is from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain possible".
Marginal mean pain scores over 24 hours
Number of Participants With Pain Control Satisfaction Via 4-pt Likert Scale
Time Frame: 24 hours after misoprostol administration
Overall satisfaction with pain control, "4" being - "Very good" and "1" being "Very bad"
24 hours after misoprostol administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study Investigator-Sponsor

Collaborators

Society of Family Planning

Investigators

  • Principal Investigator: Principal Investigator, MD MPH, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2018

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

February 15, 2018

First Submitted That Met QC Criteria

March 20, 2018

First Posted (Actual)

March 27, 2018

Study Record Updates

Last Update Posted (Actual)

August 6, 2020

Last Update Submitted That Met QC Criteria

July 23, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY19020221

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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