Opioid Use DisorderPhase 1NCT06545071
Autonomous Digital CBT Intervention for Opioid Use Disorder in Individuals With Co-Occurring Internalizing Disorders
A Phase 1 study testing NEAT-O program in people with Opioid Use Disorder and Anxiety, run by University of Minnesota at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Use Disorder, Anxiety, Depression
- What is being tested?
- NEAT-O program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2025to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current diagnosis of psychosis
- Current institutionalization (e.g., jail, hospital)
- Self-reported pregnancy
- Non-English Speakers
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Autonomous Digital CBT Intervention for Opioid Use Disorder in Individuals With Co-Occurring Internalizing Disorders - UG3
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
- Opioid Use Disorder, Anxiety, Depression
- Being tested
- NEAT-O program
- Medical subject headings
- Opioid-Related Disorders, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEAT-O programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Not described Receives: Behavioral: NEAT-O program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
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.
Measured: 45 days
Usability
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).
Measured: 45 days
Attractiveness and Information Quality
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).
Measured: 45 days
Secondary outcomes (3)
Feasibility of EMA Collection Among Individuals with OUD
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.
Measured: 45 days
Recruitment and Retention Metrics
Recruitment effectiveness and participant retention will be monitored through descriptive statistics, including counts, percentages, and adherence rates to the recruitment timeline.
Measured: 45 days
Preliminary Efficacy Indicators
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.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start21 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545071
- Sponsor's protocol ID
- 32774
- Other IDs
- UG3DA059414
- Status last verified
- Feb 2026
- First submitted
- 5 Aug 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomous Digital CBT Intervention for Opioid Use Disorder in Individuals With Co-Occurring Internalizing Disorders - UG3
- ClinicalTrials.gov ID
- NCT06545071
- Acronym / sponsor ID
- 32774
- Conditions
- Opioid Use Disorder, Anxiety, Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Behavioral: NEAT-O program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- Current diagnosis of psychosis
- Current institutionalization (e.g., jail, hospital)
- Self-reported pregnancy
- Non-English Speakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEAT-O programNEAT-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. | Behavioural | Study group |
Primary outcome
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.
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).
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).
3 secondary outcomes
Feasibility of EMA Collection Among Individuals with OUD
Time frame: 45 days
Recruitment and Retention Metrics
Time frame: 45 days
Preliminary Efficacy Indicators
Time frame: 45 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NEAT-O program in people with Opioid Use Disorder and Anxiety, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: 45 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.