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Active, Not Recruiting

NCT Number: NCT06545071

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 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Opioid Use Disorder Anxiety Anxiety Disorders Behavior Behavioral Symptoms Chemically-Induced Disorders Depression Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NEAT-O program

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.

Primary outcomes

  1. Acceptability

    Time frame: 45 days

    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.

  2. Usability

    Time frame: 45 days

    Evaluated using the System Usability Scale (SUS) to assess effectiveness, efficiency, and satisfaction. The SUS is a well-validated questionnaire with 10 items. 27 Scores of 70 or above on the SUS are considered acceptable (Post-Tx).

  3. Attractiveness and Information Quality

    Time frame: 45 days

    The Mobile Application Rating Scale (MARS) will be used to evaluate the attractiveness and information quality of NEAT-O. Scores of 3 or higher (out of a maximum score of 5) on the MARS are generally considered acceptable and indicate that the app has a high level of overall quality and content (after each module).

Secondary outcomes

  1. Feasibility of EMA Collection Among Individuals with OUD

    Time frame: 45 days

    Compliance with the EMA procedure will be assessed by tracking the number of days EMA prompts are completed as well as the average number of prompts completed per day using frequency counts and percentages.

  2. Recruitment and Retention Metrics

    Time frame: 45 days

    Recruitment effectiveness and participant retention will be monitored through descriptive statistics, including counts, percentages, and adherence rates to the recruitment timeline.

  3. Preliminary Efficacy Indicators

    Time frame: 45 days

    Patterns of opioid use (e.g., EMA data, Pre and Post-Tx measures), quality of life (WHODAS 2.0 scores), measures derived from the neurobiological domains of the addiction. These measures will be analyzed using descriptive and inferential statistics to identify early patterns and improvements.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Autonomous Digital CBT Intervention for Opioid Use Disorder in Individuals With Co-Occurring Internalizing Disorders - UG3

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 9, 2024
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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