Methadone and Medication Abortion

Methadone for Pain Relief in First Trimester Medication Abortion

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.

Study Overview

• Status: Terminated
• Conditions: Pain; Medical Abortion
• Intervention / Treatment: Drug: Methadone Pill; Drug: Ibuprofen

Detailed Description

The primary objective of this research study is to determine the feasibility of enrolling patients in a study that requires the consumption of methadone for acute pain management for medication abortion. Secondary objectives include the assessment of pain using: pain scores at 0, 4, 8, and 24 hours following misoprostol, use of supplementary analgesia, reported side effects, and patient satisfaction

All participants will be instructed to take methadone 5 mg orally (1 tablet) simultaneously with the consumption of misoprostol. The participants will be evaluated using an 11 point numeric rating pain scale with 0 (no pain) and 10 (most severe pain). Patients will be given a telephone number to which they will be asked to text study staff indicating that misoprostol and methadone have been consumed. Study staff will phone the participants at 0, 4, 8 and 24 hours post misoprostol consumption to conduct a survey posing questions about maximum pain scores, compliance with study medication and any adverse effects experienced. Participants will also be contacted at 48 hours for further evaluation of any reported adverse events and 1 week post misoprostol to assess ease of study design and instructions, pain experience, perisomal view on consumption of methadone and patient satisfaction.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

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 requesting medication abortion up to 10 weeks gestation
• Fluent English speaking
• Able and willing to receive and send text messages and receive phone calls
• Opioid naive
• Healthy patients with no significant comorbidities

Exclusion Criteria:

• Any history of drug or alcohol use, opioid use in last 30 days, chronic use of pain medications, or use of benzodiazepines.
• Any chronic disease including renal, liver, respiratory or cardiac disease
• Any known allergies to mifepristone, misoprostol, nonsteroidal anti-inflammatory drugs (such as ibuprofen) and methadone.
• Known history of QT prolongation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral methadone; Participants will be given a preemptive analgesic in addition to a standard dose of ibuprofen while undergoing early medication abortion with mifepristone and misoprostol (not provided as part of the study). All participants will also be provided with supplementary non- opioid analgesics to be used at their own discretion during the process.	Drug: Methadone Pill; All participants will be given a 5mg methadone tablet to be taken immediately following the misoprostol dose.; Other Names: Methadone Hydrochloride; Drug: Ibuprofen; All participants will be provided additional analgesics (ibuprofen 800mg x4 tabs) available for use as needed every eight hours.; Other Names: Motrin, Advil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score at 24 Hours Post Medication Abortion	Pain will be assessed using measured by an 11-point numeric visual analogue (VAS); (0-10) where 0 is equivalent to no pain and 10 is the worst pain. Higher scores are associated with more pain.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score at 8 Hours Post Medication Abortion	Pain will be assessed using measured by an 11-point numeric visual analogue (VAS); (0-10) where 0 is equivalent to no pain and 10 is the worst pain. Higher scores are associated with more pain.	8 hours
Participant Satisfaction	An investigator developed survey will be administered over the phone by study staff to assess participant satisfaction. Participants will be asked how satisfied they were with their pain management and a Likert scale will be used to collect responses. The response choices range from 0= very dissatisfied to 4= very satisfied.	24 hours, 1 week
Adverse Events	An investigator developed survey will be administered over the phone by study staff to assess adverse events including dizziness, difficulty breathing, nausea or vomiting.	24 hours, 48 hours, 1 week

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Investigators: Principal Investigator: Rachel A Achu, MD, Boston Medical Center, Anesthesiology Department

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: December 28, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Pain control; Oral methadone
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Ibuprofen; Methadone
• Other Study ID Numbers: H-41109

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
• product manufactured in and exported from the U.S.: Yes