Smartphone Apps for Opioid Use Disorder

Overseen By Andrew James, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Arkansas

Must be taking: MAT medications

Must not be taking: Beta blockers

Disqualifiers: Neurological, Cardiovascular, Infectious, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

255 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a smartphone app can help individuals with opioid use disorder avoid relapse during medication-assisted treatment. The app tracks drug use and mood and sends alerts when a person approaches locations where they are most likely to use opioids again. The researchers aim to assess the effectiveness of this tech-based approach compared to monitoring without the app. Ideal participants are those currently in the initial phase of treatment for opioid use disorder and willing to use a smartphone. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are participating in the MRI sub-study, you cannot take medications that interfere with blood flow, like beta blockers.

What prior data suggests that these smartphone apps are safe for use in opioid use disorder treatment?

Research shows that smartphone apps like OptiMAT are generally easy for people to use. In a previous study, users of a similar app for opioid addiction reported no major safety problems. These apps assist users by enabling them to track their progress and receive personalized advice, which can reduce opioid misuse.

Additionally, these apps have already succeeded in helping people reduce smoking and alcohol use. This success suggests they might be safe and effective for other addictions too. Since this trial is in Phase 2, the treatment has shown promise in earlier tests, but researchers are still assessing its safety and effectiveness with more participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using smartphone apps for opioid use disorder because they offer a personalized and interactive approach to managing the condition. Unlike standard treatments that might include medications like methadone or buprenorphine, this app, called OptiMAT, provides daily self-assessments and delivers immediate feedback to help users maintain their abstinence goals. Additionally, it uses geographic ecological momentary assessment (GEMA) to send timely push notifications when users enter high-risk areas, potentially preventing relapse. This tech-driven intervention offers a novel method of real-time support, making it an innovative addition to standard treatment options.

What evidence suggests that this smartphone app is effective for opioid use disorder?

Research has shown that smartphone apps can aid recovery from substance use problems, such as opioid addiction. In this trial, participants in the smartphone app group will use the OptiMAT app alongside standard treatment. The OptiMAT app has shown promise for individuals receiving medication-assisted treatment for opioids. Studies have found that smartphone tools improve adherence to treatment plans and reduce relapse risk. OptiMAT offers features like self-check-ins and location tracking to provide personalized advice and immediate assistance, aiming to prevent relapse in risky situations. These early results suggest that using an app like OptiMAT could enhance recovery by offering timely support and guidance. ^{1 2 3 6 7}

Who Is on the Research Team?

Andrew James, Ph.D.

Principal Investigator

University of Arkansas

Are You a Good Fit for This Trial?

Adults over 18 with opioid use disorder in early phase medication-assisted treatment can join. For the MRI study, participants must be 18-50 years old, native English speakers, and not pregnant or have certain medical conditions. They should agree to use a smartphone for the intervention.

Inclusion Criteria

I am either male or female.

I am in the initial phase of treatment for opioid addiction, receiving weekly medication.

I am willing to use a smartphone for the study if needed.

Exclusion Criteria

I have no history of serious neurological, heart diseases, infections, or significant brain injuries.

(MRI) MRI contraindications: Exclusion criteria for MRI include (1) the presence of non-removable internal (e.g., cardiac pacemakers, aneurysm clips, artificial joints) or external (e.g., piercings, orthodontics) ferromagnetic objects; (2) claustrophobia in a confined MRI environment; (3) medications that interfere with hemodynamic coupling (e.g., beta blockers); (4) hypersensitivity to loud noise; or (5) a body circumference exceeding 60cm due to broad shoulders or morbid obesity

(MRI) Pregnancy: A positive test for pregnancy prior to fMRI would exclude participation, due to unknown effect of high-field MRI on developing fetus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the OptiMAT app for daily self-monitoring and receive personalized feedback, with geographic ecological momentary assessment for targeted intervention

26 weeks

Neuroimaging Sub-study

A subset of participants undergo longitudinal functional neuroimaging to study neurocognitive mechanisms

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Smartphone

Trial Overview

The trial tests if smartphone apps can help prevent relapse in opioid addiction by monitoring drug use and providing feedback. It includes location-tracking for real-time support in high-risk areas and uses MRI scans to study brain changes linked to treatment success.

How Is the Trial Designed?

Group I: Smartphone Experimental Treatment 1 Intervention

Participants randomized into the Smartphone app arm would use the smartphone app OptiMAT in conjunction with treatment as usual (TAU). Participants would use OptiMAT to complete daily self-assessments of opiate misuse, opiate craving, opiate withdrawal, and mood. The app will personalized feedback for maintaining abstinence goals. The app would also use geographic ecological momentary assessment (GEMA) to intervene via push notification when participants enter areas previously identified as high-risk for opiate use.

Group II: Monitoring Only Active Control 1 Intervention

Participants randomized into the Monitoring Only arm would undergo treatment as usual (TAU) but without the smartphone app.

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Published Research Related to This Trial

In a study of 170 adults with opioid use disorder, those receiving a digital therapeutic alongside standard treatment had significantly higher rates of opioid abstinence (77.3% vs. 62.1%) during the final weeks of treatment.

The digital therapeutic also improved treatment retention, with participants less likely to leave treatment compared to those receiving standard care alone, while showing no increase in adverse events, indicating it is a safe and effective addition to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. Maricich, YA., Bickel, WK., Marsch, LA., et al.[2022]

A study is being conducted to evaluate the effectiveness of a smartphone app called OptiMAT as an adjunctive intervention for improving outcomes in medication-assisted treatment (MAT) for opioid use disorder (OUD), specifically targeting individuals in outpatient settings.

The trial will compare two groups: one receiving standard MAT and the other receiving MAT with the OptiMAT app, assessing opioid misuse through urinalysis over a 6-month period, which could lead to better treatment strategies in rural areas heavily affected by the opioid crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. Thompson, RG., Bollinger, M., Mancino, MJ., et al.[2023]

A study involving 20 participants over 12 weeks demonstrated that smartphone-based contingency management effectively promoted adherence to buprenorphine treatment, achieving a 76% confirmed adherence rate.

All participants remained in treatment throughout the study, and they reported high satisfaction with the app, indicating that this approach could be a practical solution for improving medication adherence in opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Preliminary Efficacy of a Smartphone-Based Contingency Management Intervention for Buprenorphine Adherence. DeFulio, A., Brown, HD., Davidson, RM., et al.[2023]

A pilot study involving 26 adults with opioid use disorder (OUD) showed that using the mobile app 'uMAT-R' significantly increased interest in treatment from 32% to 48%.

Participants also reported improved attitudes towards medication-assisted treatment (MAT), with 88% believing the app would be helpful in making recovery decisions, indicating its potential as a supportive tool in addressing the opioid epidemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. Cavazos-Rehg, PA., Krauss, MJ., Costello, SJ., et al.[2021]

The MySafeRx mobile platform, which integrates motivational coaching and adherence monitoring for buprenorphine/naloxone treatment, was found to be usable and acceptable among participants, with a high mean usability score of 78.4 and positive feedback on its features.

Despite the positive reception, the study faced challenges in recruitment and did not show significant differences in outcomes between the MySafeRx group and the standard care control group, indicating that while the platform is promising, its impact on adherence and treatment success may need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the feasibility, usability and acceptability of the MySafeRx platform among individuals in outpatient buprenorphine treatment: Lessons learned from a pilot randomized controlled trial. Janzow, GE., Harding, C., Flores, M., et al.[2023]

In a study of 180 individuals with opioid use disorders in Nairobi, Kenya, 77.2% owned mobile phones, with a high acceptability (95%) for receiving treatment via phone, particularly through text messages.

The study identified key factors influencing the acceptability of digital interventions, including education level, single marital status, smartphone ownership, and employment, which are important for designing effective digital treatment programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile phone ownership, digital technology use and acceptability of digital interventions among individuals on opioid use disorder treatment in Kenya. Kiburi, SK., Paruk, S., Chiliza, B.[2022]

A systematic review of 22 controlled trials found that mobile health applications targeting substance use disorders can effectively reduce substance use, with eight applications showing significant reductions in usage among participants.

Most applications focused on educating users about the risks of substance use and managing cravings, suggesting that addressing cravings is crucial for preventing relapse, although the studies were limited by short durations and variability in their designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inventory and Analysis of Controlled Trials of Mobile Phone Applications Targeting Substance Use Disorders: A Systematic Review. Bahadoor, R., Alexandre, JM., Fournet, L., et al.[2021]

Citations

1.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2827185

Smartphone App–Based Contingency Management and ...

This cohort study compares treatment outcomes associated with augmented medication for opioid use disorder with smartphone app–based ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10071730/

Smartphone intervention to optimize medication-assisted ...

We developed the smartphone app-based intervention OptiMAT as an adjunctive intervention to improve MOUD outcomes.

3.

ascpjournal.biomedcentral.com

ascpjournal.biomedcentral.com/articles/10.1186/s13722-025-00549-y

What smartphone apps exist to support recovery from opioid ...

To date, only three substance use apps have demonstrated their effectiveness in large-scale efficacy trials: for smoking cessation [11], alcohol ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05033028

NCT05033028 | Smartphones for Opiate Addiction Recovery

The 5-minute battery indicates the numerical probability that a patient will reuse illicit opiates within the next 7-10 days. Detailed Description. The primary ...

5.

recoveryanswers.org

recoveryanswers.org/research-post/artificial-intelligence-smartphones-predicting-opioid-use-outcomes/

Artificial intelligence and smartphones for predicting opioid ...

This study demonstrates that pairing brief daily smartphone assessments with artificial intelligence-based prediction models can yield clinically useful early ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12334106/

Development of a Sham Smartphone App for Opioid Use ...

Our sham app met our a priori criteria for suitability as a sham app. No clinical improvements from baseline were observed at the end of the ...

7.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT06134882?draw=2&rank=1

Study Details | NCT06134882 | OUD Smartphone Services

The purpose of the study is to evaluate the safety, clinical effectiveness, and cost effectiveness of the standard DynamiCare Health smartphone-smartcard ...