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NCT06545071 · ClinicalTrials.gov registry record · Phase 1
Autonomous Digital CBT Intervention for Opioid Use Disorder in Individuals With Co-Occurring Internalizing Disorders
A Phase 1 study of Depression and Anxiety, sponsored by University of Minnesota.
- Active
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT06545071: Active Phase 1 study of Depression and Anxiety, sponsored by University of Minnesota.
NCT06545071 is a Phase 1 study of Depression and Anxiety that is active but no longer recruiting, run by University of Minnesota. The registered enrollment target is 17 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06545071, a Phase 1 study of Depression and Anxiety, is active but no longer recruiting, sponsored by University of Minnesota.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Measured by the completion rate of NEAT-O modules, app usage frequency, modules accessed, and session length (after each module). Interaction frequency and module completion rates will be quantified using frequency counts and percentages.
Conditions Studied
Interventions
- BEHAVIORAL NEAT-O program
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2025-08-21 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What the registry record for NCT06545071 still lists
NCT06545071 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Depression appearing as the primary indexed condition, and to 1 intervention - of which NEAT-O program is the first listed.
NCT06545071 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT06545071 about?
NCT06545071 is a clinical study titled "Autonomous Digital CBT Intervention for Opioid Use Disorder in Individuals With Co-Occurring Internalizing Disorders". 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...
What is the current status of trial NCT06545071?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2025-08-21. Estimated completion is 2026-12-31.
What conditions does trial NCT06545071 study?
This clinical trial studies the following conditions: Depression, Anxiety, Opioid Use Disorder.
What interventions are being tested in trial NCT06545071?
The interventions under investigation include: NEAT-O program (BEHAVIORAL).
Who is sponsoring clinical trial NCT06545071?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06545071 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06545071's enrollment target sits among peer trials
17 631st of 679 higher than 46 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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