JITAI Smartphone App for Addiction

Overseen By NIDA IRP Screening Team

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Institute on Drug Abuse (NIDA)

Must be taking: Methadone, Buprenorphine

Must not be taking: Benzodiazepines

Disqualifiers: Psychotic disorder, Bipolar, Alcohol dependence, others

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

Compensation: Varies

Number of Visits: 12

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a smartphone app can assist people dealing with opioid addiction by providing timely advice. Participants will be divided into groups, with some receiving personalized messages designed to support recovery at crucial moments. The goal is to determine which approaches work best for managing addiction through this Just-In-Time Adaptive Intervention (JITAI). Ideal participants are adults with a physical dependence on opioids who are interested in smartphone-assisted treatment.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could shape future addiction treatments.

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 prior data suggests that this smartphone app is safe for treating addiction?

Research shows that Just-In-Time Adaptive Interventions (JITAIs), such as the smartphone app under study, can aid in managing addiction. These apps send helpful messages at crucial times, based on users' activities and feelings. Studies have found that people generally find these apps easy to use. Reports indicate no serious side effects, as the apps primarily offer advice and support through messages.

Since this is a digital tool and not a medication, physical side effects are not a concern. Participants will receive messages and prompts from the app, designed to help manage cravings and stress as they occur. Research has explored this method's potential to assist people with addiction, and it appears safe for users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the JITAI Smartphone App for addiction because it offers a personalized approach to treating opioid use disorder (OUD). Unlike traditional methods, which might involve medication or in-person counseling, this app delivers just-in-time adaptive interventions directly to users' smartphones. This means that individuals receive real-time support and education based on cognitive behavioral therapy (CBT) and acceptance and commitment therapy (ACT) principles exactly when they need it. Additionally, the app uses ecological momentary assessments to monitor and adapt to users' specific needs throughout the day. This innovative approach could enhance engagement and provide more immediate, tailored support compared to standard treatments.

What evidence suggests that this trial's treatments could be effective for addiction?

Research shows that Just-In-Time Adaptive Interventions (JITAIs), which participants in this trial may receive, could be a helpful tool for treating addiction. These interventions use smartphone apps to send timely messages and advice, offering support when needed most. Studies have found that JITAIs incorporate elements of Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT), both known to help with addiction. Although evidence on JITAIs' effectiveness is mixed, users generally engage with these apps at moderate-to-high levels. This suggests that JITAIs might be useful for those trying to reduce harmful substance use, such as opioids. Overall, this approach seems promising, but further research is needed to enhance its effectiveness. ^{1 2 5 6 7}

Who Is on the Research Team?

David H Epstein, Ph.D.

Principal Investigator

National Institute on Drug Abuse (NIDA)

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Baseline Assessment

Participants undergo baseline assessments of coping styles and personality

2 weeks

3 visits per week (in-person)

Treatment

Participants carry smartphones for EMA with or without JITAI, receiving CBT and ACT interventions

8 weeks

3 visits per week (in-person)

Assessment

Participants are readministered some of the assessments from baseline

1 week

3 visits (in-person)

Follow-up

Participants receiving buprenorphine are encouraged to transfer to other clinics or have their dose reduced

4 weeks

3 visits per week (in-person)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Phase 2, Arm 1: Just-in-time adaptive intervention (JITAI) group Experimental Treatment 2 Interventions

Outpatient adults who are in treatment for opioid use disorder (OUD) will receive electronic messages on their smartphone via an app and education on some basic principles of CBT and ACT. Participants will designate four one-hour time bands within their typical waking hours, covering morning through late evening. During each of those time bands, the app will push a pair of assessments, given 20 minutes apart.

Group II: Phase 2, Arm 2: Ecological momentary assessment (EMA) group (control group) Active Control 1 Intervention

Outpatient adults who are in treatment for opioid use disorder (OUD) will receive electronic messages on their smartphone via an app. Participants will designate four one-hour time bands within their typical waking hours, covering morning through late evening. During each of those time bands, the app will push a pair of assessments, given 20 minutes apart.

Group III: Phase 1, Arm 1: Formative Interviews Placebo Group 1 Intervention

Outpatient adults who are in treatment for opioid use disorder (OUD) participate in a formative-interview phase (one hour) to drive intervention formation for the trial participants groups.

Who Is Running the Clinical Trial?

National Institute on Drug Abuse (NIDA)

Lead Sponsor

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7968352/

Developments in Mobile Health Just-in-Time Adaptive ... This review aims to provide guidance for constructing effective JITAIs to support addiction treatment and recovery.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03538652?term=Addiction&viewType=Table&rank=10

Just-In-Time Adaptive Interventions for Addictive Behaviors Our JITAI will be delivered via smartphone app and will combine elements of two widely used treatments for addiction: CBT and ACT.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8918048/

Technology-mediated just-in-time adaptive interventions ... Current implementations of just-in-time adaptive interventions (JITAIs) for reducing harmful substance use rely on active measurement and static decision rules.

4. researchgate.net researchgate.net/publication/354545655_Technology-mediated_just-in-time_adaptive_interventions_JITAIs_to_reduce_harmful_substance_use_A_systematic_review

Technology‐mediated just‐in‐time adaptive interventions ... Engagement with available JITAIs was moderate-to-high and evidence of effectiveness was mixed. Due to substantial heterogeneity in study designs ...

5. researchprotocols.org researchprotocols.org/2025/1/e58917

Just-In-Time Adaptive Interventions to Promote Behavioral ... This study aims to systematically review the literature to describe the landscape of existing JITAIs for behavioral health at any stage of intervention ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5364076/

Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health A JITAI includes 6 key elements: a distal outcome, proximal outcomes, decision points, intervention options, tailoring variables, and decision rules. State of ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/add.15687

Technology‐mediated just‐in‐time adaptive interventions ... Current implementations of just-in-time adaptive interventions (JITAIs) for reducing harmful substance use rely on active measurement and static decision rules.