PainPhase 4NCT04941443
Methadone and Medication Abortion
A Phase 4 study testing Methadone Pill and Ibuprofen in people with Pain and Medical Abortion, run by Boston Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Medical Abortion
- What is being tested?
- Methadone Pill and Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2021to 1 Mar 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Methadone Pill, Ibuprofen
- Keywords
- Oral methadone, Pain control
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methadone PillDrug
Also called Methadone Hydrochloride
All participants will be given a 5mg methadone tablet to be taken immediately following the misoprostol dose.
IbuprofenDrug
Also called Motrin, Advil
All participants will be provided additional analgesics (ibuprofen 800mg x4 tabs) available for use as needed every eight hours.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Methadone Pill; Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 24 hours, 48 hours, 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start4 Oct 2021
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Why it stopped: Inability to recruit more participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel A Achu, MD, Principal investigator, Boston Medical Center, Anesthesiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941443
- Sponsor's protocol ID
- H-41109
- Status last verified
- Dec 2022
- First submitted
- 15 Jun 2021
- Last updated
- 23 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methadone for Pain Relief in First Trimester Medication Abortion
- ClinicalTrials.gov ID
- NCT04941443
- Acronym / sponsor ID
- H-41109
- Conditions
- Pain, Medical Abortion
- Keywords
- Oral methadone, Pain control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to recruit more participants.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 28 Jun 2021 (actual)
- Results
- Posted 23 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral methadone | Experimental | Drug: Methadone Pill, Drug: IbuprofenParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methadone PillAlso: Methadone HydrochlorideAll participants will be given a 5mg methadone tablet to be taken immediately following the misoprostol dose. | Drug | Oral methadone |
| IbuprofenAlso: Motrin, AdvilAll participants will be provided additional analgesics (ibuprofen 800mg x4 tabs) available for use as needed every eight hours. | Drug | Oral methadone |
Primary outcome
Pain Score at 24 Hours Post Medication Abortion
Time frame: 24 hours
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.
3 secondary outcomes
Pain Score at 8 Hours Post Medication Abortion
Time frame: 8 hours
Participant Satisfaction
Time frame: 24 hours, 1 week
Adverse Events
Time frame: 24 hours, 48 hours, 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel A Achu, MD principal investigator
Boston Medical Center, Anesthesiology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methadone Pill and Ibuprofen in people with Pain and Medical Abortion, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score at 24 Hours Post Medication Abortion (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.