JITAI Smartphone App for Addiction

Overseen By NIDA IRP Screening Team

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Institute on Drug Abuse (NIDA)

Must be taking: Methadone, Buprenorphine

Must not be taking: Benzodiazepines

Disqualifiers: Psychotic disorder, Bipolar, Alcohol dependence, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

9 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: Many smartphone apps intend to help people with addictions. But not enough is known about how they should work. Researchers want to study an app that gives people the advice they need, just when they need it. This is a JITAI. It stands for Just-In-Time Adaptive Intervention. To create a good JITAI, researchers need to know what approaches work best at different moments. Objective: To develop ways to treat addiction with a smartphone app. Eligibility: Adults ages 18-75 who use heroin or other opioids Design: Participants will be screened in another protocol. Participants will visit a Baltimore clinic 3 days a week to give urine and breath samples. Some participants will get their treatment at this clinic. Participants will answer questions about their personality and stress. Participants will randomly be assigned to the JITAI group or a comparison group. Participants will have a training session on using the smartphone app. JITAI participants will also watch a video about the written messages they ll see in the app. Weeks 3-10: participants will carry a smartphone. Four times a day, it will beep and ask questions. These will be about the participant s activities and mood. The JITAI group will see a short message after. The message is meant to be helpful. For the first 16 evenings, JITAI participants will get more information on the phone. Answers to the app s questions will be transferred automatically from the smartphone to secure computers at the NIH. During the last week, participants can choose the kind of messages they see. Week 11: participants will return the smartphone and answer questions. Weeks 12-16, participants who are getting their medicine from the research clinic will be encouraged to transfer to other clinics. Otherwise, they will have their dose slowly reduced to zero.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are receiving methadone or buprenorphine treatment for opioid dependence from a qualified provider, you can continue with that treatment while participating in the trial.

What data supports the idea that JITAI Smartphone App for Addiction is an effective treatment?

The available research shows that JITAI Smartphone Apps for Addiction are promising because they provide support exactly when it's needed, which can help people manage their addiction more effectively. For example, these apps have been used to help with gambling and substance use by offering real-time support tailored to individual needs. This approach can be more accessible and convenient than traditional methods, reaching people who might not otherwise get help. While the research highlights the potential of JITAIs, it also notes challenges in evaluating their effectiveness, suggesting that more studies are needed to fully understand their impact. ^{1 2 3 4 5}

What safety data exists for JITAI treatments for addiction?

The research does not provide specific safety data for JITAI treatments for addiction. However, it discusses the development and evaluation of JITAIs, highlighting their potential in addiction intervention science. The studies mention challenges in evaluation, such as applying micro-randomised trials, and emphasize the importance of tailoring interventions to individual needs. The SMART design is noted for its role in developing adaptive treatment strategies, which can inform the clinical management of chronic substance abuse disorders. Overall, while JITAIs are promising, specific safety data is not detailed in the provided research. ^{2 3 4 6 7}

Is the JITAI Smartphone App a promising treatment for addiction?

Yes, the JITAI Smartphone App is a promising treatment for addiction because it provides personalized support exactly when it's needed, helping people manage their addiction more effectively. This approach can reduce costs and stigma associated with addiction treatment by using mobile technology to deliver help in real-time. ^{1 2 3 4 8}

Research Team

David H Epstein, Ph.D.

Principal Investigator

National Institute on Drug Abuse (NIDA)

Eligibility Criteria

This trial is for adults aged 18-75 who are physically dependent on opioids and interested in treatment options. It's open to outpatients receiving buprenorphine or methadone from a clinic or elsewhere, but not to those with severe cognitive impairments, certain psychiatric conditions, alcohol/sedative dependence, medical illnesses that could affect participation, or issues with urine collection.

Inclusion Criteria

I am 18-75 years old, dependent on opioids, and interested in the treatment being tested.

I am 18-75, on methadone or buprenorphine for opioid dependence, and interested in the trial's treatment options.

I am between 18-75 years old, use opioids, and am interested in treatment options.

Exclusion Criteria

Phase 2: Clinical trial with microrandomization - OBOT participants: History of any DSM-V psychotic disorder; History of bipolar disorder; Current Major Depressive Disorder; Unresolved symptoms of PTSD that would make it risky for the participant to undertake mindfulness exercises in an unsupervised setting; Current dependence on alcohol or sedative-hypnotic; Cognitive impairment severe enough to preclude informed consent or valid self-report; Any condition that interferes with urine collection; Medical illness or medications that would compromise participation in research.

I am able to understand and provide valid responses in an interview.

Treatment Details

Interventions

• Just-In-Time Adaptive Interventions

Trial Overview The study tests a smartphone app (JITAI) designed to support addiction treatment by providing timely advice based on the user's mood and activities. Participants will be randomly assigned to use JITAI or a placebo version of the app while their responses are monitored over several weeks.

Participant Groups

Group I: JITAI Active Control 1 Intervention

group receiving microrandomized active intervention: JITAI with both CBT and ACT

Group II: Formative Interviews Active Control 1 Intervention

First stage, before content of mobile intervention is finalized

Group III: EMA only Placebo Group 1 Intervention

randomized control group undergoing mobile assessment without JITAI

Who Is Running the Clinical Trial?

National Institute on Drug Abuse (NIDA)

Lead Sponsor

Trials

2,658

Recruited

3,409,000+

Findings from Research

A review of 28 popular smartphone apps for depression found that none utilized just-in-time adaptive intervention (JITAI) mechanisms, which are designed to provide tailored support based on an individual's state of vulnerability and receptivity.

Most apps relied on self-reported outcomes (71%) but did not use these measurements to customize content or timing, indicating a significant gap in leveraging the potential of JITAI mechanisms to enhance the effectiveness of depression interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Just-in-Time Adaptive Mechanisms of Popular Mobile Apps for Individuals With Depression: Systematic App Search and Literature Review. Teepe, GW., Da Fonseca, A., Kleim, B., et al.[2023]

The study introduces two smartphone-based Just-In-Time Adaptive Interventions (JITAIs) for gambling behavior change, named GamblingLess: In-The-Moment and Gambling Habit Hacker, tailored to different target populations and theoretical frameworks.

The authors highlight the potential of JITAIs in addiction treatment while addressing challenges in their development and evaluation, such as the need for micro-randomised trials and recommendations for integrating various assessment methods and optimizing interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying the Just-In-Time Adaptive Intervention Framework to the Development of Gambling Interventions. Dowling, NA., Rodda, SN., Merkouris, SS.[2023]

Just-in-time adaptive interventions (JITAIs) for reducing harmful substance use have shown moderate-to-high user engagement, but their effectiveness varies across different studies, indicating a need for more consistent evidence.

Current JITAIs primarily use active measurement and static decision rules to provide tailored support based on small changes in mood or urges, but many studies lack detailed information on their implementation and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology-mediated just-in-time adaptive interventions (JITAIs) to reduce harmful substance use: a systematic review. Perski, O., Hébert, ET., Naughton, F., et al.[2023]

Mobile health (mHealth) just-in-time adaptive interventions (JITAIs) are emerging as a promising approach to support addiction treatment and recovery by delivering timely interventions through mobile devices when individuals need them most.

The review discusses the design of five mHealth JITAIs and three micro-randomized trials (MRTs), providing insights on optimizing these interventions to effectively address addiction challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developments in Mobile Health Just-in-Time Adaptive Interventions for Addiction Science. Carpenter, SM., Menictas, M., Nahum-Shani, I., et al.[2023]

The study is developing and evaluating a smartphone app called GamblingLess: In-The-Moment, which delivers tailored cognitive-behavioral interventions to individuals experiencing cognitive vulnerability related to gambling, aiming to reduce gambling episodes and symptom severity.

Using a microrandomized trial design, the app will provide real-time support to 200 participants over 28 days, with follow-up evaluations to assess long-term effects and user acceptability, highlighting its potential as an effective and accessible intervention for gambling behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Gambling Just-In-Time Adaptive Intervention (GamblingLess: In-The-Moment): Protocol for a Microrandomized Trial. Dowling, NA., Merkouris, SS., Youssef, GJ., et al.[2022]

Substance abuse is increasingly recognized as a chronic, relapsing disorder, which necessitates adaptive treatment strategies that consider the timing and ordering of interventions to improve patient outcomes.

The sequential multiple assignment randomized trial (SMART) design is highlighted as an effective method for developing these adaptive treatment strategies, offering a more tailored approach compared to standard experimental designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing adaptive treatment strategies in substance abuse research. Murphy, SA., Lynch, KG., Oslin, D., et al.[2018]

Adaptive interventions, which adjust treatment based on individual responses and preferences, are essential for optimizing patient outcomes and minimizing unnecessary treatment burdens.

The Sequential Multiple Assignment Randomized Trial (SMART) design offers a robust framework for developing and refining these adaptive interventions, as demonstrated in studies like the one involving Naltrexone, providing valuable data for personalized treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A "SMART" design for building individualized treatment sequences. Lei, H., Nahum-Shani, I., Lynch, K., et al.[2023]

A study involving 74 smokers in a clinic-based cessation program identified five key predictors of smoking lapse: perceived odds of smoking today, confidence in avoiding smoking, motivation to avoid smoking, urge to smoke, and cigarette availability.

These findings highlight the importance of using data-driven approaches to develop just-in-time adaptive interventions (JITAI) that can provide tailored support to smokers at high-risk moments, ultimately improving cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting the first smoking lapse during a quit attempt: A machine learning approach. Hébert, ET., Suchting, R., Ra, CK., et al.[2022]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Just-in-Time Adaptive Mechanisms of Popular Mobile Apps for Individuals With Depression: Systematic App Search and Literature Review. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Applying the Just-In-Time Adaptive Intervention Framework to the Development of Gambling Interventions. [2023]

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

Technology-mediated just-in-time adaptive interventions (JITAIs) to reduce harmful substance use: a systematic review. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Developments in Mobile Health Just-in-Time Adaptive Interventions for Addiction Science. [2023]

5. Canada pubmed.ncbi.nlm.nih.gov

A Gambling Just-In-Time Adaptive Intervention (GamblingLess: In-The-Moment): Protocol for a Microrandomized Trial. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

Developing adaptive treatment strategies in substance abuse research. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

A "SMART" design for building individualized treatment sequences. [2023]

8. Ireland pubmed.ncbi.nlm.nih.gov

Predicting the first smoking lapse during a quit attempt: A machine learning approach. [2022]