Methadone and Medication Abortion

NCT04941443 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: H-41109
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Medical Abortion

Keywords

Oral methadone; Pain control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pain Score at 8 Hours Post Medication Abortion

  8 hours

• Participant Satisfaction

  24 hours, 1 week

• Adverse Events

  24 hours, 48 hours, 1 week

Study Arms (1)

Oral methadone

EXPERIMENTAL

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; Drug: Ibuprofen

Interventions

Methadone Pill DRUG

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

Also known as: Methadone Hydrochloride

Oral methadone

Ibuprofen DRUG

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

Also known as: Motrin, Advil

Oral methadone

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Methadone; Ibuprofen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Limitations and Caveats

The study was halted prematurely as it was very difficult to recruit participants. Of the 4 consented participants, none provided the information needed for any of the outcome measures, so no results are available.

Results Point of Contact

• Title: Rachel Achu, MD
• Organization: Boston Medical Center, Department of Anesthesiology

rachel.achu@bmc.org

(617) 414-2000

Study Officials

• Rachel A Achu, MD

  Boston Medical Center, Anesthesiology Department

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 28, 2021
• Study Start: October 4, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: January 23, 2023
• Results First Posted: January 23, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)