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| ID | Type | Description | Link |
|---|---|---|---|
| UG1DA013732 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
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The primary objective of this study is to evaluate the ability of TOME to increase Medication for Opioid Use Disorder (MOUD) and opioid-overdose knowledge in pregnant and postpartum persons.
This is an intent-to-treat, two-arm, open-label, randomized controlled trial. Eligible participants will be randomized in a 1:1 ratio to TOME or Control, balancing on site. Participants will receive the assigned intervention following randomization and will complete a three week follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME) | Experimental | 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: Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME) TOME entails a trained RA: 1) administering a REDCap survey to assess an individual's opioid-overdose/MOUD knowledge; and 2) reviewing the personal feedback reports with the recipient. |
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| Control | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME) | Behavioral | The TOME intervention is a modified version of the personally-tailored opioid overdose prevention education and naloxone distribution (PTOEND) intervention (Winhusen et al. Evaluation of a personally-tailored opioid overdose prevention education and naloxone distribution intervention to promote harm reduction and treatment readiness in individuals actively using illicit opioids. Drug Alcohol Depend. Nov 1 2020;216:108265). Modifications include updating the knowledge assessment/education to reflect changes in the drug supply (i.e., the current high prevalence of fentanyl and increasing prevalence of xylazine) and the addition of items specific to pregnancy. Like PTOEND, TOME is a computer-guided intervention which utilizes REDCap to complete assessments and automatically generate personally-tailored feedback reports. |
| Measure | Description | Time Frame |
|---|---|---|
| Medication for Opioid Use Disorder (MOUD) Knowledge Score | 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. | Week 3 |
| Opioid Overdose Knowledge Score | 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. | Week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Medication for Opioid Use Disorder (MOUD) Internalized Stigma | 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 | Week 3 |
| Drug Self-efficacy |
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Inclusion Criteria:
Potential participants must be:
Exclusion Criteria:
Potential participants must not:
1. have suicidal or homicidal ideation requiring immediate attention.
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| Name | Affiliation | Role |
|---|---|---|
| T. John Winhusen, PhD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gateway Community Services | Jacksonville | Florida | 32204 | United States | ||
| Pregnancy Recovery Center at Magee-Womens Hospital of UPMC |
Primary data for this study will be available to the public in the NIDA data repository, per NIDA CTN policy.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 9, 2024 |
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This is an intent-to-treat, two-arm, open-label, randomized controlled trial.
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| Control | Behavioral | Participants randomized to the control condition will be offered three SAMHSA handouts. |
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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 |
| Week 3 |
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Utah SUPeRAD Clinic | Salt Lake City | Utah | 84108 | United States |
| Marshall Health MARC Program | Huntington | West Virginia | 25701 | United States |
| FG001 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Medication for Opioid Use Disorder (MOUD) Knowledge Score | 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. | Mean | Standard Deviation | percentage of correct answers |
| ||||||||||||||||
| Opioid Overdose Knowledge Score | 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. | Mean | Standard Deviation | percentage of correct answers |
| ||||||||||||||||
| Medication for Opioid Use Disorder (MOUD) Internalized Stigma | 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 | Mean | Standard Deviation | average score |
| ||||||||||||||||
| Drug Self-efficacy | 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 | Mean | Standard Deviation | average score |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Medication for Opioid Use Disorder (MOUD) Knowledge Score | 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. | Several participants were lost to follow-up, explaining why the Week 3 participant numbers analyzed differs from the overall. | Posted | Mean | Standard Deviation | percentage of correct answers | Week 3 |
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| Primary | Opioid Overdose Knowledge Score | 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. | Several participants were lost to follow-up, explaining why the Week 3 participant numbers analyzed differs from the overall. | Posted | Mean | Standard Deviation | percentage of correct answers | Week 3 |
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| Secondary | Medication for Opioid Use Disorder (MOUD) Internalized Stigma | 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 | Several participants were lost to follow-up, explaining why the Week 3 participant numbers analyzed differs from the overall. | Posted | Mean | Standard Deviation | average score | Week 3 |
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| Secondary | Drug Self-efficacy | 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 | Several participants were lost to follow-up, explaining why the Week 3 participant numbers analyzed differs from the overall. | Posted | Mean | Standard Deviation | average score | Week 3 |
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Consent through Week 3
Staff assessed for two AEs that would be of clinical import: 1. Suicidal ideation and 2. Homicidal ideation. SAEs were only reported for events related to a study-defined AE (e.g., hospitalization due to suicidal ideation, etc.).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) | 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. | 0 | 67 | 0 | 67 | 0 | 67 |
| EG001 | 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. | 0 | 64 | 0 | 64 | 0 | 64 |
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A significant limitation is that the participant sample was primarily White (89.3%) and non-Latino (92.4%) and, thus, it is unknown whether the results would generalize to a more racially and ethnically diverse population.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| T. John Winhusen, PhD. | University of Cincinnati | 513-585-8292 | winhust@ucmail.uc.edu |
| Apr 2, 2025 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 1, 2024 | Nov 20, 2024 | ICF_000.pdf |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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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. |
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