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Methadone and Medication Abortion

NCT04941443 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2023-01-23

Study results available
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Summary

Pain has been recognized to be the most common and predictable side effect of medication abortion, causing significant distress associated with the process. Yet there is little known about the appropriate management of pain during this process, with no current evidence based recommendations for optimal analgesic regimens during the first trimester.

The goal of this study is to evaluate the efficacy of oral methadone for pain control during medication abortion. The current medication regimen used to perform medication abortion is a dose of mifepristone (antiprogesterone) orally, followed by a dose of misoprostol (prostaglandin analogue) 24 to 72 hours later. Patients are prescribed a standard dose of ibuprofen 600-800mg tabs for pain control during the process. The investigators will conduct a non-randomized, pilot study with 25 patients evaluated at the Boston Medical Center family planning clinic at 10 weeks of gestation or less for medication abortion.

Conditions

  • Pain
  • Medical Abortion

Interventions

DRUG

Methadone Pill

All participants will be given a 5mg methadone tablet to be taken immediately following the misoprostol dose.

DRUG

Ibuprofen

All participants will be provided additional analgesics (ibuprofen 800mg x4 tabs) available for use as needed every eight hours.

Sponsors & Collaborators

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Rachel A Achu, MD · Boston Medical Center, Anesthesiology Department

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-04
Primary Completion
2022-03-01
Completion
2022-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT04941443 on ClinicalTrials.gov