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

NCT ID: NCT06545071

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-21

Study Completion Date

2025-12-14

Brief Summary

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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.

Detailed Description

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Conditions

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Opioid Use Disorder Anxiety Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Study group

Group Type EXPERIMENTAL

NEAT-O program

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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UG3DA059414

Identifier Type: NIH

Identifier Source: secondary_id

View Link

32774

Identifier Type: -

Identifier Source: org_study_id