Trial Outcomes & Findings for Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) for Pregnant and Postpartum Persons in MOUD (NCT NCT06262347)
NCT ID: NCT06262347
Last Updated: 2025-05-11
Results Overview
This outcome is measured by the Opioid Overdose and Treatment Awareness Survey (OOTAS) knowledge evaluation: MOUD knowledge, potential score of 0-10; higher score indicates more knowledge. Values are converted to a percentage of correct answers from 0-100% where higher percentages mean more knowledge.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
131 participants
Primary outcome timeframe
Week 3
Results posted on
2025-05-11
Participant Flow
Participant milestones
| Measure |
Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME)
Drug: Naloxone kit
TOME: Each participant's knowledge of Medication for Opioid Use Disorder (MOUD) and opioid-related overdose (OOD) was assessed. A trained research assistant met individually with the participant for ≤15 minutes to review incorrect answers and explain the correct answers using four computer-generated feedback reports: 1) MOUD; 2) OOD risk factors; 3) signs of an OOD; and 4) how to respond to an OOD. Participants were offered a copy of their personal feedback reports.
|
Control
Drug: Naloxone kit
Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. This nasal spray is approved by the FDA for reversing OODs and has a favorable side-effects profile. A take-home kit will be provided to participants, which may be useful in the event of a future opioid overdose.
Behavioral: SAMHSA handouts
SAMHSA handouts: 1) "Opioid Overdose Prevention Toolkit: Safety Advice for Patients and Family Members"; 2) "Opioid Overdose Prevention Toolkit: Recovering from Opioid Overdose"; and 3) "Medication-Assisted Treatment for Opioid Addiction: Facts for Families and Friends". These handouts can be offered as physical copies or electronically.
Control: Participants randomized to the control condition will be offered three SAMHSA handouts.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
64
|
|
Overall Study
COMPLETED
|
63
|
60
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME)
Drug: Naloxone kit
TOME: Each participant's knowledge of Medication for Opioid Use Disorder (MOUD) and opioid-related overdose (OOD) was assessed. A trained research assistant met individually with the participant for ≤15 minutes to review incorrect answers and explain the correct answers using four computer-generated feedback reports: 1) MOUD; 2) OOD risk factors; 3) signs of an OOD; and 4) how to respond to an OOD. Participants were offered a copy of their personal feedback reports.
|
Control
Drug: Naloxone kit
Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. This nasal spray is approved by the FDA for reversing OODs and has a favorable side-effects profile. A take-home kit will be provided to participants, which may be useful in the event of a future opioid overdose.
Behavioral: SAMHSA handouts
SAMHSA handouts: 1) "Opioid Overdose Prevention Toolkit: Safety Advice for Patients and Family Members"; 2) "Opioid Overdose Prevention Toolkit: Recovering from Opioid Overdose"; and 3) "Medication-Assisted Treatment for Opioid Addiction: Facts for Families and Friends". These handouts can be offered as physical copies or electronically.
Control: Participants randomized to the control condition will be offered three SAMHSA handouts.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) for Pregnant and Postpartum Persons in MOUD
Baseline characteristics by cohort
| Measure |
Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME)
n=67 Participants
Drug: Naloxone kit
Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. This nasal spray is approved by the FDA for reversing OODs and has a favorable side-effects profile. A take-home kit will be provided to participants, which may be useful in the event of a future opioid overdose.
Behavioral: TOME
TOME: Each participant's knowledge of Medication for Opioid Use Disorder (MOUD) and opioid-related overdose (OOD) was assessed. A trained research assistant met individually with the participant for ≤15 minutes to review incorrect answers and explain the correct answers using four computer-generated feedback reports: 1) MOUD; 2) OOD risk factors; 3) signs of an OOD; and 4) how to respond to an OOD. Participants were offered a copy of their personal feedback reports.
|
Control
n=64 Participants
Drug: Naloxone kit
Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. This nasal spray is approved by the FDA for reversing OODs and has a favorable side-effects profile. A take-home kit will be provided to participants, which may be useful in the event of a future opioid overdose.
Behavioral: SAMHSA handouts
SAMHSA handouts: 1) "Opioid Overdose Prevention Toolkit: Safety Advice for Patients and Family Members"; 2) "Opioid Overdose Prevention Toolkit: Recovering from Opioid Overdose"; and 3) "Medication-Assisted Treatment for Opioid Addiction: Facts for Families and Friends". These handouts can be offered as physical copies or electronically.
Control: Participants randomized to the control condition will be offered three SAMHSA handouts.
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
67 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
31.6 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
30.7 years
STANDARD_DEVIATION 4.8 • n=7 Participants
|
31.2 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Medication for Opioid Use Disorder (MOUD) Knowledge Score
|
64.0 percentage of correct answers
STANDARD_DEVIATION 15.4 • n=5 Participants
|
69.5 percentage of correct answers
STANDARD_DEVIATION 12.1 • n=7 Participants
|
66.7 percentage of correct answers
STANDARD_DEVIATION 14.1 • n=5 Participants
|
|
Opioid Overdose Knowledge Score
|
81.7 percentage of correct answers
STANDARD_DEVIATION 7.1 • n=5 Participants
|
82.5 percentage of correct answers
STANDARD_DEVIATION 5.6 • n=7 Participants
|
82.1 percentage of correct answers
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Medication for Opioid Use Disorder (MOUD) Internalized Stigma
|
1.8 average score
STANDARD_DEVIATION 0.7 • n=5 Participants
|
1.7 average score
STANDARD_DEVIATION 0.8 • n=7 Participants
|
1.7 average score
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Drug Self-efficacy
|
2.6 average score
STANDARD_DEVIATION 2.6 • n=5 Participants
|
2.7 average score
STANDARD_DEVIATION 2.9 • n=7 Participants
|
2.6 average score
STANDARD_DEVIATION 2.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 3Population: Several participants were lost to follow-up, explaining why the Week 3 participant numbers analyzed differs from the overall.
This outcome is measured by the Opioid Overdose and Treatment Awareness Survey (OOTAS) knowledge evaluation: MOUD knowledge, potential score of 0-10; higher score indicates more knowledge. Values are converted to a percentage of correct answers from 0-100% where higher percentages mean more knowledge.
Outcome measures
| Measure |
Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME)
n=63 Participants
Drug: Naloxone kit
Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. This nasal spray is approved by the FDA for reversing OODs and has a favorable side-effects profile. A take-home kit will be provided to participants, which may be useful in the event of a future opioid overdose.
Behavioral: TOME
TOME: Each participant's knowledge of Medication for Opioid Use Disorder (MOUD) and opioid-related overdose (OOD) was assessed. A trained research assistant met individually with the participant for ≤15 minutes to review incorrect answers and explain the correct answers using four computer-generated feedback reports: 1) MOUD; 2) OOD risk factors; 3) signs of an OOD; and 4) how to respond to an OOD. Participants were offered a copy of their personal feedback reports.
|
Control
n=60 Participants
Drug: Naloxone kit
Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. This nasal spray is approved by the FDA for reversing OODs and has a favorable side-effects profile. A take-home kit will be provided to participants, which may be useful in the event of a future opioid overdose.
Behavioral: SAMHSA handouts
SAMHSA handouts: 1) "Opioid Overdose Prevention Toolkit: Safety Advice for Patients and Family Members"; 2) "Opioid Overdose Prevention Toolkit: Recovering from Opioid Overdose"; and 3) "Medication-Assisted Treatment for Opioid Addiction: Facts for Families and Friends". These handouts can be offered as physical copies or electronically.
Control: Participants randomized to the control condition will be offered three SAMHSA handouts.
|
|---|---|---|
|
Medication for Opioid Use Disorder (MOUD) Knowledge Score
|
83.5 percentage of correct answers
Standard Deviation 15.6
|
72.0 percentage of correct answers
Standard Deviation 14.2
|
PRIMARY outcome
Timeframe: Week 3Population: Several participants were lost to follow-up, explaining why the Week 3 participant numbers analyzed differs from the overall.
This outcome is measured by the first three sections of the Opioid Overdose and Treatment Awareness Survey (OOTAS). Opioid-overdose knowledge, potential score of 0-31; higher score indicates more knowledge. Values are converted to a percentage of correct answers from 0-100% where higher percentages mean more knowledge.
Outcome measures
| Measure |
Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME)
n=63 Participants
Drug: Naloxone kit
Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. This nasal spray is approved by the FDA for reversing OODs and has a favorable side-effects profile. A take-home kit will be provided to participants, which may be useful in the event of a future opioid overdose.
Behavioral: TOME
TOME: Each participant's knowledge of Medication for Opioid Use Disorder (MOUD) and opioid-related overdose (OOD) was assessed. A trained research assistant met individually with the participant for ≤15 minutes to review incorrect answers and explain the correct answers using four computer-generated feedback reports: 1) MOUD; 2) OOD risk factors; 3) signs of an OOD; and 4) how to respond to an OOD. Participants were offered a copy of their personal feedback reports.
|
Control
n=60 Participants
Drug: Naloxone kit
Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. This nasal spray is approved by the FDA for reversing OODs and has a favorable side-effects profile. A take-home kit will be provided to participants, which may be useful in the event of a future opioid overdose.
Behavioral: SAMHSA handouts
SAMHSA handouts: 1) "Opioid Overdose Prevention Toolkit: Safety Advice for Patients and Family Members"; 2) "Opioid Overdose Prevention Toolkit: Recovering from Opioid Overdose"; and 3) "Medication-Assisted Treatment for Opioid Addiction: Facts for Families and Friends". These handouts can be offered as physical copies or electronically.
Control: Participants randomized to the control condition will be offered three SAMHSA handouts.
|
|---|---|---|
|
Opioid Overdose Knowledge Score
|
90.1 percentage of correct answers
Standard Deviation 7.6
|
82.6 percentage of correct answers
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: Week 3Population: Several participants were lost to follow-up, explaining why the Week 3 participant numbers analyzed differs from the overall.
This will be assessed with the The Methadone Maintenance Treatment Stigma Mechanisms Scale (MMT-SMS) questionnaire. Score range: 1 - 5; higher score indicates greater MOUD stigma
Outcome measures
| Measure |
Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME)
n=63 Participants
Drug: Naloxone kit
Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. This nasal spray is approved by the FDA for reversing OODs and has a favorable side-effects profile. A take-home kit will be provided to participants, which may be useful in the event of a future opioid overdose.
Behavioral: TOME
TOME: Each participant's knowledge of Medication for Opioid Use Disorder (MOUD) and opioid-related overdose (OOD) was assessed. A trained research assistant met individually with the participant for ≤15 minutes to review incorrect answers and explain the correct answers using four computer-generated feedback reports: 1) MOUD; 2) OOD risk factors; 3) signs of an OOD; and 4) how to respond to an OOD. Participants were offered a copy of their personal feedback reports.
|
Control
n=60 Participants
Drug: Naloxone kit
Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. This nasal spray is approved by the FDA for reversing OODs and has a favorable side-effects profile. A take-home kit will be provided to participants, which may be useful in the event of a future opioid overdose.
Behavioral: SAMHSA handouts
SAMHSA handouts: 1) "Opioid Overdose Prevention Toolkit: Safety Advice for Patients and Family Members"; 2) "Opioid Overdose Prevention Toolkit: Recovering from Opioid Overdose"; and 3) "Medication-Assisted Treatment for Opioid Addiction: Facts for Families and Friends". These handouts can be offered as physical copies or electronically.
Control: Participants randomized to the control condition will be offered three SAMHSA handouts.
|
|---|---|---|
|
Medication for Opioid Use Disorder (MOUD) Internalized Stigma
|
1.5 average score
Standard Deviation 0.7
|
1.6 average score
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Week 3Population: Several participants were lost to follow-up, explaining why the Week 3 participant numbers analyzed differs from the overall.
This will be assessed with the Thoughts about abstinence (TAA) instrument. Drug Self-efficacy Score range: 0 - 9; higher score indicates greater expected success in avoiding drug use
Outcome measures
| Measure |
Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME)
n=63 Participants
Drug: Naloxone kit
Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. This nasal spray is approved by the FDA for reversing OODs and has a favorable side-effects profile. A take-home kit will be provided to participants, which may be useful in the event of a future opioid overdose.
Behavioral: TOME
TOME: Each participant's knowledge of Medication for Opioid Use Disorder (MOUD) and opioid-related overdose (OOD) was assessed. A trained research assistant met individually with the participant for ≤15 minutes to review incorrect answers and explain the correct answers using four computer-generated feedback reports: 1) MOUD; 2) OOD risk factors; 3) signs of an OOD; and 4) how to respond to an OOD. Participants were offered a copy of their personal feedback reports.
|
Control
n=60 Participants
Drug: Naloxone kit
Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. This nasal spray is approved by the FDA for reversing OODs and has a favorable side-effects profile. A take-home kit will be provided to participants, which may be useful in the event of a future opioid overdose.
Behavioral: SAMHSA handouts
SAMHSA handouts: 1) "Opioid Overdose Prevention Toolkit: Safety Advice for Patients and Family Members"; 2) "Opioid Overdose Prevention Toolkit: Recovering from Opioid Overdose"; and 3) "Medication-Assisted Treatment for Opioid Addiction: Facts for Families and Friends". These handouts can be offered as physical copies or electronically.
Control: Participants randomized to the control condition will be offered three SAMHSA handouts.
|
|---|---|---|
|
Drug Self-efficacy
|
2.3 average score
Standard Deviation 2.9
|
1.9 average score
Standard Deviation 2.6
|
Adverse Events
Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place