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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06545071
The ClinicalTrials.gov registry entry for NCT06545071 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (98% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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