Smartphone for Ecological Momentary Assessment

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Brain Imaging Research Center, Little Rock, AR
Ecological Momentary Assessment+6 More
Smartphone - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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.

Eligible Conditions

  • Ecological Momentary Assessment
  • Opiate Substitution Treatment
  • Attentional Bias
  • Magnetic Resonance Imaging (MRI)
  • Craving
  • Opioid Abuse
  • Mobile Applications

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

27 Primary · 33 Secondary · Reporting Duration: 6 months

1 day
TLFB - Month 0 (Intake)
Urinalysis - Week 0 (Intake)
1 month
TLFB - Month 1
1 week
Treatment Continuation - Week 1
Urinalysis - Week 1
10 weeks
Treatment Continuation - Week 10
Urinalysis - Week 10
11 weeks
Treatment Continuation - Week 11
Urinalysis - Week 11
12 weeks
Treatment Continuation - Week 12
Urinalysis - Week 12
13 weeks
Treatment Continuation - Week 13
Urinalysis - Week 13
14 weeks
Treatment Continuation - Week 14
Urinalysis - Week 14
15 weeks
Treatment Continuation - Week 15
Urinalysis - Week 15
16 weeks
Treatment Continuation - Week 16
Urinalysis - Week 16
17 weeks
Treatment Continuation - Week 17
Urinalysis - Week 17
18 weeks
Treatment Continuation - Week 18
Urinalysis - Week 18
19 weeks
Treatment Continuation - Week 19
Urinalysis - Week 19
2 months
TLFB - Month 2
2 weeks
Treatment Continuation - Week 2
Urinalysis - Week 2
20 weeks
Treatment Continuation - Week 20
Urinalysis - Week 20
21 weeks
Treatment Continuation - Week 21
Urinalysis - Week 21
22 weeks
Treatment Continuation - Week 22
Urinalysis - Week 22
23 weeks
Treatment Continuation - Week 23
Urinalysis - Week 23
24 weeks
Treatment Continuation - Week 24
Urinalysis - Week 24
25 weeks
Treatment Continuation - Week 25
Urinalysis - Week 25
26 weeks
Treatment Continuation - Week 26
Urinalysis - Week 26
3 months
TLFB - Month 3
3 weeks
Treatment Continuation - Week 3
Urinalysis - Week 3
4 months
TLFB - Month 4
4 weeks
Treatment Continuation - Week 4
Urinalysis - Week 4
5 months
TLFB - Month 5
5 weeks
Treatment Continuation - Week 5
Urinalysis - Week 5
6 months
TLFB - Month 6
6 weeks
Treatment Continuation - Week 6
Urinalysis - Week 6
7 weeks
Treatment Continuation - Week 7
Urinalysis - Week 7
8 weeks
Treatment Continuation - Week 8
Urinalysis - Week 8
9 weeks
Treatment Continuation - Week 9
Urinalysis - Week 9

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Monitoring Only
1 of 2
Smartphone
1 of 2
Active Control
Experimental Treatment

255 Total Participants · 2 Treatment Groups

Primary Treatment: Smartphone · No Placebo Group · Phase 2

Smartphone
Device
Experimental Group · 1 Intervention: Smartphone · Intervention Types: Device
Monitoring OnlyNoIntervention Group · 1 Intervention: Monitoring Only · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Smartphone
2016
Completed Phase 4
~6970

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
Closest Location: Brain Imaging Research Center · Little Rock, AR
Photo of Little Rock 1Photo of Little Rock 2Photo of Little Rock 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Ecological Momentary Assessment
0 CompletedClinical Trials

Who is running the clinical trial?

University of ArkansasLead Sponsor
455 Previous Clinical Trials
139,584 Total Patients Enrolled
Andrew James, Ph.D.Principal InvestigatorUniversity of Arkansas

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are female.\n
You have a native English-speaking mother.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.