Clinical trial NCT06701123: mHealth to Help Pregnant and Postpartum Women in Recovery for Opioid Use Disorder
Official title: mHealth to Help Pregnant and Postpartum Women in Recovery for Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Opioid Use Disorders
Keywords: Addiction
mhealth
Women
Substance use disorder
intervention
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-11-22
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. In Aim #1, we will conduct four focus groups with PPW with OUD (target users) on the intervention components of uMAT-R, gathering feedback on theory-driven components that are candidates for inclusion in the tool and eliciting suggestions for additional intervention components. In Aim #2, the tool will be beta-tested for technical/navigational issues among 20 participants. In Aim #3, we will conduct a pilot randomized controlled trial (RCT) among adult PPW with OUD (n=60). This RCT is designed to test the feasibility, acceptability, and preliminary efficacy of uMAT-R (n=40) versus a control group (n=20 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.

This novel technology could be an invaluable tool to assist physicians in the treatment of OUD among PPW.


Eligibility criteria: Inclusion Criteria:

1. Pregnant or up to 1 year postpartum
2. Receiving treatment at CARE
3. Adult (≥18 years of age)
4. U.S. resident
5. Currently on MAT
6. Fluent in English
7. women with opioid use disorder (OUD)

   Exclusion Criteria:
8. Currently incarcerated
9. Patients with acute suicidality or psychotic disorders as assessed by CARE providers

Primary outcomes:
measure: Sobriety
timeFrame: Baseline, 1 month, 2 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References: