NCT07673380

Brief Summary

The sequential trial compares recovery and mHealth engagement outcomes among Black participants who participated in the mHealth intervention uMAT-R or uMAT-R + enhanced community engagement. The mHealth intervention seeks to support people in various stages of recovery who are also seeking other forms of substance use treatment. Participants are recruited from community-based substance use treatment facilities and recovery services. Participants must be adults who have or are currently using opioids and/or stimulants.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
5mo left

Started Aug 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
Aug 2025Feb 2027

Study Start

First participant enrolled

August 31, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 29, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

June 17, 2026

Last Update Submit

June 22, 2026

Conditions

Opioid UseStimulant UseDepression and Anxiety Symptoms

Keywords

Digital healthCommunity engagement

Outcome Measures

Primary Outcomes (2)

  • Abstinence/ Changes in Substance Use

    Frequency of opioid use, stimulant, and/or other substance use (e.g., discordant with prescribed usage) or other substances (e.g., stimulants, other non-opioid illicit drugs) in the past 30-day will be assessed by items from the National Survey on Drug Use and Health (NSDUH) questionnaire. The score indicates days on using any substance listed above over past 30-day, ranging from 0 to 30, with a higher score reflecting more frequent substance use.

    Time 0 (Baseline) and Time 1 (One Month)

  • Opioid use/ Stimulant use disorder symptoms

    The number of DSM-5-TR diagnostic criteria met for opioid use disorder (OUD) and stimulant use disorder (StUD) will be assessed. Scores range from 0 to 11, with higher scores indicating that more diagnostic criteria are met for the disorder.

    Time 0 (Baseline) and Time 1 (One Month)

Secondary Outcomes (5)

  • Depression symptoms

    Time 0 (Baseline) and Time 1 (One-Month)

  • Anxiety Symptoms

    Time 0 (Baseline) and Time 1 (One-Month)

  • Basic needs

    Time 0 (Baseline) and Time 1 (One-Month)

  • Medication for Opioid Use Disorder (MOUD) Attitudes

    Time 0 (Baseline), and Time 1 (One-Month)

  • Substance Use Disorder (SUD) Treatment Engagement

    Time 0 (Baseline), and Time 1 (One-Month)

Other Outcomes (3)

  • Client/User Experience

    Time 1 (One-Month)

  • uMAT-R App Engagement

    From Time 0 to Time 1

  • uMAT-R E-coach Engagement

    Time 0 to Time 1

Study Arms (2)

uMAT-R + enhanced community engagement

EXPERIMENTAL

uMAT-R + enhanced community engagement involves an optimized community engagement strategy employed by the intervention team.

Behavioral: uMAT-R + enhanced community engagement

Original uMAT-R supplementary mHealth recovery intervention

ACTIVE COMPARATOR

uMAT-R supplementary mHealth recovery intervention is the original intervention disseminated without optimization of the community engagement approach.

Behavioral: Original uMAT-R supplementary mHealth recovery intervention

Interventions

uMAT-R + enhanced community engagementBEHAVIORAL

uMAT-R + enhanced community engagement involves an optimized community engagement strategy employed by the intervention team. This involves in-person interactions with eligible participants and recruitment sites.

uMAT-R + enhanced community engagement
Original uMAT-R supplementary mHealth recovery interventionBEHAVIORAL

uMAT-R supplementary mHealth recovery intervention is the original intervention without optimization of the community engagement approach.

Original uMAT-R supplementary mHealth recovery intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a history of opioid and/or stimulant use
  • Identify as Black and/or African American
  • Seek treatment at local substance use treatment centers
  • Fluent in English
  • U.S. resident
  • years of age or older at the time of data collection.

You may not qualify if:

  • Self-reported cognitive impairment that would limit ability to participate in research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Central Study Contacts

Hannah Szlyk

CONTACT

917-836-4225szlyk@wustl.edu

Elecia Worley

CONTACT

e.m.worley@wustl.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2026

First Posted

June 29, 2026

Study Start

August 31, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

June 29, 2026

Record last verified: 2026-06

Locations

US(1)