Drug Abuse, Drug Abuse in Pregnancy, Drug Addiction, Opioid Use Disorder, Pregnancy Related, Substance Use
Conditions
Keywords
CTN-0150, clinical trials network
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPersonally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME)
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.
BEHAVIORALControl
Participants randomized to the control condition will be offered three SAMHSA handouts.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
T. John Winhusen, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is an intent-to-treat, two-arm, open-label, randomized controlled trial.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Potential participants must be: 1. 18 years of age or older; 2. Pregnant or be within 12 months postpartum; 3. Enrolled in MOUD (either buprenorphine or methadone) at the study site or affiliated clinic where enrollment can be confirmed; 4. Able to understand the study, and having understood, provide written informed consent in English
Exclusion criteria
Potential participants must not: 1\. have suicidal or homicidal ideation requiring immediate attention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication for Opioid Use Disorder (MOUD) Knowledge Score | Week 3 | 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. |
| Opioid Overdose Knowledge Score | Week 3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication for Opioid Use Disorder (MOUD) Internalized Stigma | Week 3 | 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 |
| Drug Self-efficacy | Week 3 | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 67 |
| 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. | 64 |
| Total | 131 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Control | Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 64 Participants | 67 Participants | 131 Participants |
| Age, Continuous | 30.7 years STANDARD_DEVIATION 4.8 | 31.6 years STANDARD_DEVIATION 5 | 31.2 years STANDARD_DEVIATION 4.9 |
| Drug Self-efficacy | 2.7 average score STANDARD_DEVIATION 2.9 | 2.6 average score STANDARD_DEVIATION 2.6 | 2.6 average score STANDARD_DEVIATION 2.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 3 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 57 Participants | 64 Participants | 121 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Medication for Opioid Use Disorder (MOUD) Internalized Stigma | 1.7 average score STANDARD_DEVIATION 0.8 | 1.8 average score STANDARD_DEVIATION 0.7 | 1.7 average score STANDARD_DEVIATION 0.8 |
| Medication for Opioid Use Disorder (MOUD) Knowledge Score | 69.5 percentage of correct answers STANDARD_DEVIATION 12.1 | 64.0 percentage of correct answers STANDARD_DEVIATION 15.4 | 66.7 percentage of correct answers STANDARD_DEVIATION 14.1 |
| Opioid Overdose Knowledge Score | 82.5 percentage of correct answers STANDARD_DEVIATION 5.6 | 81.7 percentage of correct answers STANDARD_DEVIATION 7.1 | 82.1 percentage of correct answers STANDARD_DEVIATION 6.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 59 Participants | 58 Participants | 117 Participants |
| Sex: Female, Male Female | 64 Participants | 67 Participants | 131 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 64 |
| other Total, other adverse events | 0 / 67 | 0 / 64 |
| serious Total, serious adverse events | 0 / 67 | 0 / 64 |
Outcome results
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.
Time frame: Week 3
Population: Several participants were lost to follow-up, explaining why the Week 3 participant numbers analyzed differs from the overall.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) | Medication for Opioid Use Disorder (MOUD) Knowledge Score | 83.5 percentage of correct answers | Standard Deviation 15.6 |
| Control | Medication for Opioid Use Disorder (MOUD) Knowledge Score | 72.0 percentage of correct answers | Standard Deviation 14.2 |
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.
Time frame: Week 3
Population: Several participants were lost to follow-up, explaining why the Week 3 participant numbers analyzed differs from the overall.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) | Opioid Overdose Knowledge Score | 90.1 percentage of correct answers | Standard Deviation 7.6 |
| Control | Opioid Overdose Knowledge Score | 82.6 percentage of correct answers | Standard Deviation 6.2 |
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
Time frame: Week 3
Population: Several participants were lost to follow-up, explaining why the Week 3 participant numbers analyzed differs from the overall.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) | Drug Self-efficacy | 2.3 average score | Standard Deviation 2.9 |
| Control | Drug Self-efficacy | 1.9 average score | Standard Deviation 2.6 |
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
Time frame: Week 3
Population: Several participants were lost to follow-up, explaining why the Week 3 participant numbers analyzed differs from the overall.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) | Medication for Opioid Use Disorder (MOUD) Internalized Stigma | 1.5 average score | Standard Deviation 0.7 |
| Control | Medication for Opioid Use Disorder (MOUD) Internalized Stigma | 1.6 average score | Standard Deviation 0.8 |