Actively Recruiting
Developing a Smartphone Application to Support the Functional Needs of Veterans in Medication Treatment for Opioid Use Disorder
Led by VA Office of Research and Development · Updated on 2025-08-27
75
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to develop and evaluate a smartphone application called "ACT to RECOVER" to support Veterans with Opioid Use Disorder (OUD) who are receiving medication treatment. OUD is a chronic condition affecting many Veterans, often leading to poorer quality of life and challenges in social and occupational functioning. The study focuses on improving functional outcomes for Veterans in medication treatment for OUD by addressing gaps in current care. The study involves three phases: Phase 1 focuses on developing the app content with feedback from Veterans and providers over 15 months. Phase 2 involves iterative usability testing in three rounds with Veterans using a beta version of the app to refine its format and usability over 18 months. Phase 3 is a Stage 1b randomized controlled trial where Veterans are assigned to use either the ACT to RECOVER app or a smartphone-based symptom monitoring program for 4 weeks, with follow-up visits at 2, 4, and 5 weeks. Participants will complete baseline assessments and outcome measures including quality of life, values-based living, opioid use, and app usability. Data collection includes interviews, questionnaires, and app usage tracking throughout the study phases. The research team will evaluate the acceptability, feasibility, and preliminary functional and clinical outcomes to inform future efficacy testing. Total study duration spans multiple years, with the pilot trial lasting about 5 weeks per participant.
CONDITIONS
Brief Title
Developing a Smartphone Application to Support Veteran Opioid Use Disorder Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Veterans enrolled within the VA CT Healthcare System
- Current diagnosis of Opioid Use Disorder confirmed by DSM-5-TR or ICD-9/10 codes
- Active medication treatment for Opioid Use Disorder with buprenorphine or methadone
- Access to a working smartphone with wireless capabilities or willingness to use a study-provided smartphone
- Competent to provide written informed consent
- 18 years of age or older
You will not qualify if you...
- Being on medication treatment for Opioid Use Disorder for longer than 12 consecutive months in the current treatment episode
- Untreated major psychiatric disorders such as bipolar or psychotic disorders
- Current active suicidal or homicidal ideation with intent
- Cognitive or medical impairments preventing study participation or use of smartphones or apps
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 15 months
Participants provide feedback on intervention content drafts and participate in qualitative interviews to assess acceptability and feasibility of the ACT to RECOVER app.
Multiple interviews with small groups of participants over the phase
Duration - Up to 18 months
Participants test the beta-version of the ACT to RECOVER app through guided and unguided usage while providing feedback during usability sessions including interviews and questionnaires.
Multiple visits including baseline and iterative usability sessions across 3 waves with approximately 2 weeks between waves
Duration - 5 weeks
Participants randomized to receive the ACT to RECOVER smartphone intervention use the app over 4 weeks with assessments of acceptability, feasibility, and clinical outcomes.
1 baseline visit, 1 midpoint visit (week 2), 1 endpoint visit (week 4), and 1 follow-up visit (week 5)
Duration - 5 weeks
Participants randomized to receive the smartphone-based symptom-monitoring program use the app over 4 weeks with similar assessments as the treatment group.
1 baseline visit, 1 midpoint visit (week 2), 1 endpoint visit (week 4), and 1 follow-up visit (week 5)
Trial Site Locations
Total: 1 location
1
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States, 06516-2770
Actively Recruiting
Research Team
N
Noah R Wolkowicz, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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