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

Trial Summary

What is the purpose of this trial?

The proposed clinical trial would evaluate the use of smartphone applications ("apps", which have well-established efficacy in reducing cigarette and alcohol use) to prevent relapse among patients receiving medication-assisted treatment for opioid use disorder. In addition to standard app-based self-monitoring of drug use and personalized feedback, project innovation is enhanced by the proposed use of location-tracking technology for targeted, personalized intervention when participants enter self-identified areas of high risk for relapse. Furthermore, the proposed sub-study would use longitudinal functional neuroimaging to elucidate the brain-cognition relationships underlying individual differences in treatment outcomes, offering broad significance for understanding and enhancing the efficacy of this and other app-based interventions.

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 data supports the effectiveness of the smartphone app treatment for opioid use disorder?

Research shows that smartphone apps can help people stick to their medication plans and reduce opioid misuse. For example, a study found that a smartphone app helped people consistently take their medication for opioid use disorder, with 76% adherence, and all participants stayed in treatment. ^{1 2 3 4 5}

Is using smartphone apps for opioid use disorder treatment safe?

Research shows that smartphone apps used alongside medication for opioid use disorder are generally safe. Participants in studies were able to use the apps without any reported safety issues, and they found the apps easy to use and helpful. ^{1 2 4 5 6}

How is the smartphone app treatment for opioid use disorder different from other treatments?

The smartphone app treatment for opioid use disorder is unique because it provides a digital, low-cost, and accessible way to support recovery by delivering scientifically-backed health information and just-in-time interventions, which can help improve medication-assisted treatment outcomes and reduce opioid misuse. ^{1 2 3 7 8}

Research Team

Andrew James, Ph.D.

Principal Investigator

University of Arkansas

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. [2021]

4. Netherlands 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. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Preliminary Efficacy of a Smartphone-Based Contingency Management Intervention for Buprenorphine Adherence. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Prospective acceptability of digital phenotyping among pregnant and parenting people with opioid use disorder: A multisite qualitative study. [2023]

7. Switzerland 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. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Inventory and Analysis of Controlled Trials of Mobile Phone Applications Targeting Substance Use Disorders: A Systematic Review. [2021]