Opioid Use Disorders
Conditions
Keywords
Addiction, mhealth, Women, Substance use disorder, intervention
Brief summary
The opioid epidemic has resulted in widespread detrimental consequences among vulnerable populations in Missouri, especially among pregnant and postpartum women (PPW) with opioid use disorder (OUD). Perinatal use of medication-assisted treatment (MAT) within a comprehensive treatment plan is the current standard of care, however PPW struggling with OUD may underestimate or misjudge its benefits. At the same time, emerging findings signal that mobile health (mHealth) technologies have the potential to support healthier behaviors among individuals with OUD. In this project, we will test the utility of a theoretically-based digital therapeutics tool (uMAT-R) to encourage MAT adherence and treatment retention while considering the unique needs of PPW. We will conduct a pilot randomized controlled trial (RCT) among adult PPW with OUD. This RCT is designed to test the feasibility, acceptability, and preliminary efficacy of uMAT-R mobile app versus a control group (who receive treatment-as-usual) regarding participants' treatment adherence, sobriety, and improved MAT attitudes, norms, and perceived control. Recruitment for all Aims will occur at a clinic in St. Louis, Missouri that provides perinatal medication-assisted treatment (MAT) and high-risk maternity care to PPW struggling with OUD. Clinically meaningful effect size and attrition estimates will aid in the planning of a larger RCT in which we will test uMAT-R on a larger scale and expand our recruitment to other clinics across Missouri and other states. In addition, local providers who work with pregnant and postpartum people with substance use disorder and/or at a recovery community center will be recruited to provide their feedback. This novel technology could be an invaluable tool to assist physicians in the treatment of OUD among PPW.
Interventions
DEVICEuMAT-R mobile app with coaching component
uMAT-R recovery mobile app with coaching component
Sponsors
Washington University School of Medicine
National Institute on Drug Abuse (NIDA)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Pregnant and Postpartum Participants: Inclusion Criteria: 1. Pregnant or up to 3 years postpartum 2. Receiving treatment consenting treatment facility and/or referred from other participants or community partners 3. Adult (≥18 years of age) 4. U.S. resident 5. OUD or history of opioid misuse 6. Fluent in English 7. Own a smartphone with an iOS or Android operating system
Exclusion criteria
1\) Currently incarcerated Providers Inclusion Criteria: 1. Works with pregnant and postpartum people with opioid use disorder and/or at a recovery community center (e.g. a staff person, counselor, social worker, psychiatrist, nurse). 2. Adult (≥18 years of age) 3. Fluent in English 4. Own a smartphone with an iOS or Android operating system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cravings | Baseline, 1 month | Craving was assessed using the Penn Alcohol Craving Scale (PACS), adapted for opioid craving by replacing alcohol-specific wording with opioid-specific wording. The PACS is a 5-item self-report measure assessing craving over the past week. However, in the current version, we only included 3 items: "(1) How much do you currently crave illicit substances (i.e. opioids, meth, cocaine, MDMAs, etc.)", "(2) In the past week, please rate how strong your desire to use illicit substances has been when something in the environment has reminded you of the illicit substance(s)." and "(3) Please imagine yourself in the environment in which you previous used illicit substances. If you were in this environment today and if it were the time of day that you typically use, what is the likelihood that you would use illicit substances today?" Each item is scored 0 to 10 and summed to a total score ranging from 0 to 30, with higher scores indicating greater craving/worse outcome. |
| MOUD Attitudes | Baseline, 1 month | MOUD attitudes were assessed using an adapted 8-item scale originally developed to assess negative attitudes toward methadone (Schwartz et al., 2008) and modified to reference medications for opioid use disorder (e.g., buprenorphine, methadone, naltrexone). Each item was rated on a 5-point scale from 1 to 5. A total score was calculated as the mean of the 8 items, with possible values ranging from 1 to 5. Higher scores indicate more negative attitudes toward MOUD/worse outcome. |
Countries
United States
Participant flow
Recruitment details
Pregnant and postpartum individuals who met eligibility criteria were shown the informed consent form. Those who consented to participate and completed their baseline survey were provided access to the intervention (N= 109). Providers from regional treatment facilities in both Missouri and neighboring Illinois were recruited via email or telephone for enrollment (n=16).
Pre-assignment details
Please note that outcome results are only included for pregnant and postpartum participants. Due to challenges recruiting pregnant and postpartum individuals, all pregnant and post-partum participants recruited were enrolled in the Aim 3 RCT and that sample is reported here.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age of Participants 18-30 years old | 70 Participants |
| Age, Customized Age of Participants 31-50 years old | 43 Participants |
| Age, Customized Age of Participants 51+ | 2 Participants |
| Age, Customized Age of Participants Missing | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 38 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 57 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 57 | 0 / 13 |
| other Total, other adverse events | 0 / 52 | 0 / 57 | 0 / 13 |
| serious Total, serious adverse events | 0 / 52 | 0 / 57 | 0 / 13 |
Outcome results
None listed