Methadone and Medication Abortion

NCT ID: NCT04941443

Last Updated: 2023-01-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-04
• Study Completion Date: 2022-03-01

Brief 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.

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.

Conditions

Pain; Medical Abortion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Methadone Pill

Intervention Type: DRUG

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

Ibuprofen

Intervention Type: DRUG

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

Interventions

Methadone Pill

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

Intervention Type: DRUG

Ibuprofen

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

Intervention Type: DRUG

Other Intervention Names

Methadone Hydrochloride; Motrin, Advil

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel A Achu, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center, Anesthesiology Department

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H-41109

Identifier Type: -

Identifier Source: org_study_id