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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
Must not have
Phase 1: Formative interviews - Cognitive impairment severe enough to preclude informed consent or valid interview responses.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 minutes

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am able to understand and provide valid responses in an interview.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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
2,607 Previous Clinical Trials
3,329,750 Total Patients Enrolled
David H Epstein, Ph.D.Principal InvestigatorNational Institute on Drug Abuse (NIDA)
5 Previous Clinical Trials
663 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
~12 spots leftby May 2025
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