Trial Outcomes & Findings for Methadone and Medication Abortion (NCT NCT04941443)
NCT ID: NCT04941443
Last Updated: 2023-01-23
Results Overview
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.
TERMINATED
PHASE4
4 participants
24 hours
2023-01-23
Participant Flow
Participant milestones
| Measure |
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.
Methadone Pill: All participants will be given a 5mg methadone tablet to be taken immediately following the misoprostol dose.
Ibuprofen: All participants will be provided additional analgesics (ibuprofen 800mg x4 tabs) available for use as needed every eight hours.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Methadone and Medication Abortion
Baseline characteristics by cohort
| Measure |
Oral Methadone
n=4 Participants
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.
Methadone Pill: All participants will be given a 5mg methadone tablet to be taken immediately following the misoprostol dose.
Ibuprofen: All participants will be provided additional analgesics (ibuprofen 800mg x4 tabs) available for use as needed every eight hours.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Of the 4 consented participants, none provided the information needed for any of the outcome measures, so no results are available.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 hoursPopulation: Of the 4 consented participants, none provided the information needed for any of the outcome measures, so no results are available.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hours, 1 weekPopulation: Of the 4 consented participants, none provided the information needed for any of the outcome measures, so no results are available.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hours, 48 hours, 1 weekPopulation: Of the 4 consented participants, none provided the information needed for any of the outcome measures, so no results are available.
An investigator developed survey will be administered over the phone by study staff to assess adverse events including dizziness, difficulty breathing, nausea or vomiting.
Outcome measures
Outcome data not reported
Adverse Events
Oral Methadone
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Rachel Achu, MD
Boston Medical Center, Department of Anesthesiology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place