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

University of Minnesota (UMN)

Status and phase: Begins enrollment in 3 months; Phase 1

Conditions: Opioid Use Disorder; Depression; Anxiety

Treatments: Behavioral: NEAT-O program

Study type: Interventional

Funder types: Other

Identifiers

NCT06545071

32774

UG3DA059414 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Study group

Experimental group

Treatment:

Behavioral: NEAT-O program