NCT06545071

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 - UG3

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Opioid Use Disorder
• Anxiety
• Depression

Interventions

Type	Name	Description
BEHAVIORAL	NEAT-O program	NEAT-O's curriculum is designed to interrupt the cycle of negative emotions and opioid use through a multifaceted approach encompassing physiological, psychological, and behavioral strategies. The program includes interactive modules that capture the core therapeutic components of CBT and teach skills to support OUD recovery.

Timeline

• Start date: 2025-08-21
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-08-09
• Last updated: 2026-02-12

Locations

1 site across 1 country: United States