NEAT-O Program for Opioid Use Disorder

Overseen By Justin Anker, Ph.D

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Minnesota

Must be taking: MOUD

Disqualifiers: Psychosis, Institutionalization, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital therapy program called NEAT-O, designed for individuals with opioid use disorder (OUD) who also experience anxiety or mood disorders, such as depression. The goal is to determine if this program is user-friendly and beneficial for those facing these challenges. Individuals diagnosed with OUD, currently receiving treatment, and experiencing anxiety or depression may find this trial suitable, particularly if they own a smartphone and reside in the United States. As a Phase 1 trial, participants will be among the first to help researchers understand how this new treatment works in people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since participants must be in treatment for opioid use disorder using medication, it seems you can continue with your current treatment.

What prior data suggests that the NEAT-O program is safe for individuals with opioid use disorder?

Research shows that digital Cognitive Behavioral Therapy (CBT) programs like NEAT-O are being tested for people with opioid use disorder (OUD). NEAT-O remains in the early stages of testing, so detailed safety information is limited. However, CBT is a well-established therapy for mental health issues and is generally considered safe.

The study is in its first phase, focusing on ensuring the program is user-friendly and acceptable to participants. Researchers aim to determine if people can use it easily without negative effects. As a digital therapy, it has no physical side effects, but researchers are monitoring for any potential negative impacts on mental health.

While specific safety data for NEAT-O is not yet available, its progression to larger trials suggests some confidence in its safety. This phase will help refine the program before testing it with more participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The NEAT-O program is unique because it offers a fresh approach to treating opioid use disorder by focusing on a comprehensive, individualized treatment plan rather than relying solely on medication like methadone or buprenorphine. Researchers are excited because this program integrates behavioral therapies and support systems to address the psychological and social aspects of addiction, which are often overlooked by conventional treatments. Additionally, the NEAT-O program emphasizes a personalized treatment path, potentially leading to better engagement and outcomes for individuals struggling with opioid addiction.

What evidence suggests that the NEAT-O program is effective for opioid use disorder?

Research has shown that cognitive behavioral therapy (CBT) effectively treats many mental health issues, including those related to substance use. The NEAT-O program, which participants in this trial will receive, adapts CBT specifically for individuals facing opioid use disorder (OUD) along with anxiety or mood disorders. Although little direct evidence exists about NEAT-O's success in people, CBT's proven success in similar situations suggests it could be helpful. The program is designed to address the specific challenges of managing both OUD and mental health problems. Early results from other CBT applications indicate it can help reduce substance use and improve mental health. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 in the US with opioid use disorder and anxiety or depression, who are currently receiving medication-assisted treatment. Participants must have a smartphone with internet to access the digital CBT program NEAT-O.

Inclusion Criteria

I have given my informed consent.

I have a smartphone with internet for the study period.

I currently live in the United States.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Testing

Pilot testing of NEAT-O, a digital CBT program for individuals with OUD and internalizing disorders

6 weeks

Digital interactions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NEAT-O program

Trial Overview NEAT-O, a digital Cognitive Behavioral Therapy program, is being tested for its usability and acceptability among individuals with opioid addiction and co-occurring mental health issues like anxiety or depression.

How Is the Trial Designed?

Group I: Study group Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Citations

1. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7325a1.htm

Treatment for Opioid Use Disorder: Population Estimates In 2022, 3.7% of US adults aged ≥18 years needed OUD treatment. Among these, only 25.1% received medications for OUD.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32022884/

Comparative Effectiveness of Different Treatment Pathways for ... Treatment with buprenorphine or methadone was associated with reductions in overdose and serious opioid-related acute care use compared with other treatments.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2760032

Comparative Effectiveness of Different Treatment Pathways ... Treatment with buprenorphine or methadone was associated with reductions in overdose and serious opioid-related acute care use compared with other treatments.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2949875925001237

Evaluation of a primary care-based Medication for Opioid ... Data collected from July 1, 2022 to December 31, 2022 showed a 6-month retention rate of 85 % (N = 186). Urine drug screens were opioid-negative for 91 % of ...

5. substanceabusepolicy.biomedcentral.com substanceabusepolicy.biomedcentral.com/articles/10.1186/s13011-021-00424-4

Outcomes from the medication assisted treatment pilot ... This study shows decreased substance use, improved physical and mental health, and reduced symptoms after 6 months of MOUD.

6. withpower.com withpower.com/trial/phase-1-substance-related-disorders-2025-cf9ec

NEAT-O Program for Opioid Use Disorder This Phase 1 medical study run by University of Minnesota is evaluating whether NEAT-O program will have tolerable side effects & efficacy for patients with ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7801772/

Three-month outcomes from a patient-centered program to ... This study shows that people with OUD can achieve a high treatment retention rate, cut down their use of illicit drugs, and build their recovery capital. More ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2817002

Public Health Interventions and Overdose-Related ... The model projected decreases of up to 35.2% in nonfatal and 36.6% in fatal opioid-involved overdoses among persons with OUD.

9. pew.org pew.org/en/research-and-analysis/issue-briefs/2022/10/states-should-measure-opioid-use-disorder-treatment-to-improve-outcomes

States Should Measure Opioid Use Disorder Treatment to ... Studies have shown that long-term treatment can lead to better outcomes in employment, health, and criminal justice involvement.28 In addition, ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S2352853225000069

Association between different modalities of opioid use ... This study assessed the impact of different modalities of delivery of opioid use disorder (OUD)-related care on several patient outcomes.