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Autonomous Digital CBT Intervention for Opioid Use Disorder in Individuals With Co-Occurring Internalizing Disorders

Autonomous Digital CBT Intervention for Opioid Use Disorder in Individuals With Co-Occurring Internalizing Disorders

Recruiting
18-65 years
All
Phase 1

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Overview

The primary objective of this protocol is to implement the UG3 phase (Phase 1) of a National Institute on Drug Abuse (NIDA) UG3/UH3 grant (RFA-DA-23-049). This phase is dedicated to the pilot testing of NEAT-O, a digital Cognitive Behavioral Therapy (CBT) program tailored for individuals with opioid use disorder (OUD) and concurrent anxiety or mood disorders - collectively referred to as internalizing disorders (INTDs). NEAT-O is based on an empirically supported CBT framework, specifically modified to address the complexities of comorbidity in substance use disorders (SUDs). This pilot study will evaluate the usability and acceptability of NEAT-O in 15 participants with OUD, with the goal of refining the program's content and delivery methods. The results of the pilot study will inform a comprehensive RCT in the UH3 Phase (Phase 2) (N=300). Progression to the UH3 phase, with its funding, depends on meeting milestones in Phase 1 including demonstrating protocol adherence and the program's acceptability and usability.

Eligibility

Inclusion Criteria:

  • Adults ages 18 to 65
  • Current DSM-5 diagnosis of OUD (confirmed during MINI 7 interview)
  • Current DSM-5 diagnosis of panic disorder with or without agoraphobia (PD/Ag) generalized anxiety disorder, social anxiety disorder, or major depression (confirmed during MINI 7 interview)
  • Currently in treatment for OUD using MOUD
  • Access to an internet-enabled smartphone for the duration of the study
  • Currently residing in the United States
  • Provision of informed consent

Exclusion Criteria:

  • Current diagnosis of psychosis
  • Current institutionalization (e.g., jail, hospital)
  • Self-reported pregnancy
  • Non-English Speakers

Study details
    Opioid Use Disorder
    Anxiety
    Depression

NCT06545071

University of Minnesota

15 October 2025

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