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

NCT03480009 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: STUDY19020221
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Abortion in First Trimester

Keywords

medication abortion; dextromethorphan; pain control

Outcome Measures

Primary Outcomes (2)

• Worst Pain Measurement Via Numeric Rating Scale (NRS-11)

  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

  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 Outcomes (2)

• Mean Pain Scores Via Numeric Rating Scale (NRS-11)

  Marginal mean pain scores over 24 hours

• Number of Participants With Pain Control Satisfaction Via 4-pt Likert Scale

  24 hours after misoprostol administration

Study Arms (4)

Dextromethorphan, opted for narcotic prescription

EXPERIMENTAL

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

Drug: Dextromethorphan Hydrobromide; Drug: Oxycodone

Placebo, opted for narcotic prescription

PLACEBO COMPARATOR

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

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

Dextromethorphan, declined narcotic prescription

EXPERIMENTAL

Dextromethorphan hydrobromide and patient declines narcotic

Drug: Dextromethorphan Hydrobromide

Placebo, declined narcotic prescription

PLACEBO COMPARATOR

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

Drug: Avicel PH101 (Microcrystalline Cellulose NF) for Compounding

Interventions

Dextromethorphan Hydrobromide DRUG

Dextromethorphan capsule

Also known as: Robitussin, Delsym

Dextromethorphan, declined narcotic prescription; Dextromethorphan, opted for narcotic prescription

Avicel PH101 (Microcrystalline Cellulose NF) for Compounding DRUG

Placebo capsule

Also known as: Avicel

Placebo, declined narcotic prescription; Placebo, opted for narcotic prescription

Oxycodone DRUG

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

Also known as: Tylox, Percodan, OxyContin

Dextromethorphan, opted for narcotic prescription; Placebo, opted for narcotic prescription

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Must be pregnant to participate
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Study Investigator-Sponsor: lead
• Society of Family Planning: collaborator

Study Sites (2)

Center for Family Planning Research, Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Planned Parenthood of Western Pennsylvania

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (6)

• Penney G. Treatment of pain during medical abortion. Contraception. 2006 Jul;74(1):45-7. doi: 10.1016/j.contraception.2006.03.002. Epub 2006 May 6.

  PMID: 16781260 BACKGROUND

• Weinbroum AA, Rudick V, Paret G, Ben-Abraham R. The role of dextromethorphan in pain control. Can J Anaesth. 2000 Jun;47(6):585-96. doi: 10.1007/BF03018952.

  PMID: 10875724 BACKGROUND

• Ilkjaer S, Nielsen PA, Bach LF, Wernberg M, Dahl JB. The effect of dextromethorphan, alone or in combination with ibuprofen, on postoperative pain after minor gynaecological surgery. Acta Anaesthesiol Scand. 2000 Aug;44(7):873-7. doi: 10.1034/j.1399-6576.2000.440715.x.

  PMID: 10939702 BACKGROUND

• Christie A, Dagfinrud H, Dale O, Schulz T, Hagen KB. Collection of patient-reported outcomes;--text messages on mobile phones provide valid scores and high response rates. BMC Med Res Methodol. 2014 Apr 16;14:52. doi: 10.1186/1471-2288-14-52.

  PMID: 24735061 BACKGROUND

• Practice bulletin no. 143: medical management of first-trimester abortion. Obstet Gynecol. 2014 Mar;123(3):676-692. doi: 10.1097/01.AOG.0000444454.67279.7d.

  PMID: 24553166 BACKGROUND

• Ferguson GP, Achilles SL, Meyn LA, Krajewski CM, Chappell CA, Vinekar K, Chen BA. Dextromethorphan as a novel nonopioid adjunctive agent for pain control with medication abortion: A randomized controlled trial. Contraception. 2023 Feb;118:109908. doi: 10.1016/j.contraception.2022.10.010. Epub 2022 Nov 2.

  PMID: 36332661 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Dextromethorphan; Acetylcysteine; microcrystalline cellulose; Cellulose; Oxycodone; oxycodone-acetaminophen; Aspirin-oxycodone hydrochloride-oxycodone terephthalate combination

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Codeine; Morphine Derivatives

Results Point of Contact

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

fpr@upmc.edu

412-641-5496

Study Officials

• Principal Investigator, MD MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: March 27, 2018
• Study Start: July 28, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: August 6, 2020
• Results First Posted: August 6, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)