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

NCT03480009 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2020-08-06

Study results available
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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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Principal Investigator, MD MPH · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-28
Primary Completion
2019-06-30
Completion
2019-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03480009 on ClinicalTrials.gov