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Behavioral Intervention

JITAI Smartphone App for Addiction

Phase 2
Recruiting
Led By David H Epstein, Ph.D.
Research Sponsored by National Institute on Drug Abuse (NIDA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 minutes
Awards & highlights

Study Summary

This trial is testing a smartphone app that sends just-in-time adaptive intervention (JITAI) messages to people with addiction, in order to help them quit.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this intervention involves using an app rather than medication, traditional side effects aren't expected. However, participants may experience discomfort or stress related to self-monitoring and responding to personal questions about mood and activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Differential responses over time
Distal effects of JITAI on self-efficacy and coping flexibility
Proximal effects of CBT and ACT messages in a JITAI
+1 more
Secondary outcome measures
Trait predictors of responsiveness
push versus pull

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: JITAIActive Control1 Intervention
group receiving microrandomized active intervention: JITAI with both CBT and ACT
Group II: Formative InterviewsActive Control1 Intervention
First stage, before content of mobile intervention is finalized
Group III: EMA onlyPlacebo Group1 Intervention
randomized control group undergoing mobile assessment without JITAI

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)Lead Sponsor
2,468 Previous Clinical Trials
2,619,163 Total Patients Enrolled
David H Epstein, Ph.D.Principal InvestigatorNational Institute on Drug Abuse (NIDA)
5 Previous Clinical Trials
740 Total Patients Enrolled

Media Library

Just-In-Time Adaptive Interventions (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03538652 — Phase 2
Addiction Research Study Groups: JITAI, EMA only, Formative Interviews
Addiction Clinical Trial 2023: Just-In-Time Adaptive Interventions Highlights & Side Effects. Trial Name: NCT03538652 — Phase 2
Just-In-Time Adaptive Interventions (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03538652 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial currently enrolling participants?

"Affirmative. According to the clinicaltrials.gov page, this research project is still open for recruitment and began on February 19th of 2020 with a most recent update in November 4th 2022. The study requires 185 subjects from 1 location."

Answered by AI

What criteria must be met in order to participate in this research program?

"This clinical trial requires 185 participants with behavioural and substance addictions aged 18 to 75. Qualifying individuals must meet the following criteria: For outpatients, they need 35 enrollees between ages 18-75 that self-report physical opioid dependence as well as an interest in our treatment options. Those qualified for OBOT participation require positive urine screens or frank opioid withdrawal alongside age and treatment interests. Our Phase 2 microrandomization necessitates TE participants who are receiving methadone or buprenorphine from a certified provider within their community while also sharing an affinity for our treatments being tested during Phase 1 formative interviews."

Answered by AI

What is the total participant count for this medical research project?

"Affirmative. The relevant information available on clinicaltrials.gov indicates that this medical trial, which was first published on February 19th 2020, is actively recruiting participants. It requires 185 people to enroll from 1 centre in order to proceed with the study."

Answered by AI

What risks do people taking JITAI face?

"By our estimation, JITAI's safety level is a 2 given the absence of clinical data in support of efficacy. Nonetheless, there is some evidence that suggests its security."

Answered by AI

Is this experiment exclusively for those over seventy-five years of age or are younger participants being considered?

"As mandated by the guidelines of this particular trial, only patients aged 18 or older but under 75 are allowed to enrol."

Answered by AI

What ultimate outcomes is this experiment striving to accomplish?

"The primary measure of success in this JITAI trial will be its proximal effects. Secondary objectives include gauging the efficacy of push versus pull interventions, and investigating if trait variables such as personality or preferred coping styles influence responsiveness to CBT-based and ACT-based messages over an end of study time frame."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

Okay so Im addicted to . . . sugar! I'm a member of a 12 step program for sugar (food) addiction. When I have a sweet I MUST have more . . . so I try to abstain, sometimes for weeks or months at a time . . . and I always come back. I lost 50 pounds a few years ago and have maintained a normal weight , but it is a constant struggle.
PatientReceived 1 prior treatment
~36 spots leftby May 2025