Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06454903

Developing a Smartphone Application to Support Veteran Opioid Use Disorder Treatment

Led by VA Office of Research and Development · Updated on 2025-08-27

75

Participants Needed

1

Research Sites

234 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Opioid Use Disorder (OUD) is a complex, chronic condition affecting nearly 70,000 Veterans who can experience significantly reduced quality of life (e.g., poorer social, occupational, and health-related functioning). VA clinics providing Medication treatment for OUD (MOUD; e.g., buprenorphine, methadone), the 1st-line treatment for OUD, often face challenges in also attempting to treat Veteran functional needs, which may require them to extend beyond their available resources to provide support. There is an urgent need for functionally impactful and accessible treatments for Veterans in MOUD. Acceptance and Commitment Therapy (ACT) is a well-suited framework to support the functioning of Veterans in MOUD with over 20 years of research support. However, the traditional practice ACT requires a trained clinician to provide weekly, hour-long therapy sessions (typically for 12-16 weeks) and may be too burdensome for MOUD clinics to use alongside standard care. Fortunately, emerging research suggests that mobile health interventions (MHIs; e.g., smartphone apps) can overcome many of these pragmatic barriers. MHIs can efficiently deliver functionally-focused treatments focused on Veteran functioning in "real-world" settings, through minimally burdensome and accessible formats. Currently however, no MHI's targeting functioning exist for Veterans in MOUD. The proposed study will address this gap by developing and evaluating an early prototype of a targeted smartphone app designed to enhance the functional outcomes of Veterans receiving MOUD called "ACT to RECOVER" (Acceptance and Commitment Therapy to Reach Empowerment through Commitment, Openness, and Valuing Experiences in Recovery). The study will occur in 3 phases: Phase 1: Development. Develop content for ACT to RECOVER using Veteran (n=10) and provider feedback (n=10). Phase 2: Iterative Usability Assessment. Conduct field testing (3 rounds, n=4-5 per round) to refine ACT to RECOVER format, acceptability, and usability. Phase 3: Pilot ACT to RECOVER in a Stage 1b Randomized Controlled Trial (RCT). Conduct a pilot trial to compare ACT to RECOVER (n=20) to a smartphone-based symptom monitoring control group (n=20). * (3a) Evaluate the acceptability and feasibility of each condition's app and study procedures. * (3b) Explore changes in functional (e.g., values-based living, quality of life) and clinical outcomes (e.g., illicit opioid use) which will be key outcomes in future efficacy testing.

CONDITIONS

Official Title

Developing a Smartphone Application to Support Veteran Opioid Use Disorder Treatment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Current diagnosis of Opioid Use Disorder confirmed by DSM-5-TR or ICD-9/10 codes
  • Receiving active medication treatment for OUD with buprenorphine or methadone
  • Own a working smartphone with wireless capability or willing to use a study-provided smartphone
  • Able to provide written informed consent
  • 18 years of age or older
Not Eligible

You will not qualify if you...

  • On medication treatment for OUD for more than 12 consecutive months in current treatment episode
  • Untreated major psychiatric disorders such as bipolar disorder or psychotic disorders
  • Currently experiencing active suicidal or homicidal thoughts or intent
  • Cognitive or medical impairments that prevent participation or use of smartphones/apps

AI-Screening

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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

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Research Team

N

Noah R Wolkowicz, PhD

CONTACT

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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Developing a Smartphone Application to Support Veteran Opioid Use Disorder Treatment | DecenTrialz