Clinical trial NCT04941443: Methadone and Medication Abortion
Official title: Methadone for Pain Relief in First Trimester Medication Abortion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain
Medical Abortion
Keywords: Oral methadone
Pain control
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain Score at 24 Hours Post Medication Abortion
timeFrame: 24 hours
Secondary outcomes:
measure: Pain Score at 8 Hours Post Medication Abortion
timeFrame: 8 hours
measure: Participant Satisfaction
timeFrame: 24 hours, 1 week
measure: Adverse Events
timeFrame: 24 hours, 48 hours, 1 week
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center, Anesthesiology Department
name: Rachel A Achu, MD
role: PRINCIPAL_INVESTIGATOR
References: