Neurocognitive Mechanisms Underlying Smartphone-Assisted Prevention of Relapse in Opioid Use Disorder

May 12, 2026 updated by: University of Arkansas
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The rising public health burden of opioid misuse, coupled with high relapse rates among individuals seeking treatment for opioid use disorder, necessitates novel interventions for improving opioid-related treatment response. Mobile technology such as smartphone-based applications ("apps") represent one such intervention. Although smartphone apps are effective in reducing cigarette and alcohol use, their efficacy for reducing opioid use has not yet been established. The proposed clinical trial would evaluate the app OptiMAT ("Optimizing Medication-Assisted Treatment") to prevent relapse among patients receiving medication-assisted treatment for opioid use disorder. OptiMAT implements two features shown to be effective for reducing substance use: daily self-monitoring of opiate use coupled with personalized feedback. Aim 1 would accrue 255 participants with 1:1 randomization into two arms (OptiMAT vs. Monitoring only) to evaluate differences in monthly opioid use at six months post-enrollment. Aim 2 would enroll a subset of participants (N=120; 60 per arm) into a longitudinal functional neuroimaging (fMRI) study to model the neurocognitive mechanisms underlying individual differences in treatment response. Two putative mechanisms (attentional bias for drug cues and cue-induced craving) promoting abstinence would be studied. Aim 3 would explore the use of location-based geographic ecological momentary assessment (GEMA) for targeted intervention when participants enter self-identified areas of high risk for relapse. Collectively, the proposed aims would (1) evaluate mobile technology applications for reducing opiate use, (2) understand the neurocognitive mechanisms of action to improve upon this and other apps aiming to reduce drug use, and (3) evaluate the role of personalized, contextually-relevant intervention to promote successful treatment outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
336

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72227
        • Brain Imaging Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Sex: male or female
  • Age: 18 years and older
  • (MRI sub-study): Age: 18-50 years old
  • In Phase I treatment of MAT for opioid-use disorder. (Phase I indicates that patient is receiving no more than one week of take-home medications at each weekly clinic visit.)
  • Must be willing to use a smartphone if randomized to the smartphone intervention arm
  • (MRI sub-study): Native English-speaking

Exclusion Criteria:

  • (MRI) Medical history: A history of neurological, cardiovascular, or infectious disease would exclude study participation. A loss of consciousness of 20 or more min or other evidence of brain trauma also would be exclusionary.
  • (MRI) Pregnancy: A positive test for pregnancy prior to fMRI would exclude participation, due to unknown effect of high-field MRI on developing fetus.
  • (MRI) MRI contraindications: Exclusion criteria for MRI include (1) the presence of non-removable internal (e.g., cardiac pacemakers, aneurysm clips, artificial joints) or external (e.g., piercings, orthodontics) ferromagnetic objects; (2) claustrophobia in a confined MRI environment; (3) medications that interfere with hemodynamic coupling (e.g., beta blockers); (4) hypersensitivity to loud noise; or (5) a body circumference exceeding 60cm due to broad shoulders or morbid obesity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Smartphone
Participants randomized into the Smartphone app arm would use the smartphone app OptiMAT in conjunction with treatment as usual (TAU). Participants would use OptiMAT to complete daily self-assessments of opiate misuse, opiate craving, opiate withdrawal, and mood. The app will personalized feedback for maintaining abstinence goals. The app would also use geographic ecological momentary assessment (GEMA) to intervene via push notification when participants enter areas previously identified as high-risk for opiate use.
Device: Smartphone
Adjunctive Smartphone app for improving MAT outcomes
Other Names:
  • OptiMAT, "Optimizing MAT"
No Intervention: Monitoring Only
Participants randomized into the Monitoring Only arm would undergo treatment as usual (TAU) but without the smartphone app.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Urinalysis - Week 0 (Intake)
Time Frame: 1 day
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
1 day
Urinalysis - Week 1
Time Frame: 1 week
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
1 week
Urinalysis - Week 2
Time Frame: 2 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
2 weeks
Urinalysis - Week 3
Time Frame: 3 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
3 weeks
Urinalysis - Week 4
Time Frame: 4 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
4 weeks
Urinalysis - Week 5
Time Frame: 5 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
5 weeks
Urinalysis - Week 6
Time Frame: 6 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
6 weeks
Urinalysis - Week 7
Time Frame: 7 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
7 weeks
Urinalysis - Week 8
Time Frame: 8 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
8 weeks
Urinalysis - Week 9
Time Frame: 9 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
9 weeks
Urinalysis - Week 10
Time Frame: 10 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
10 weeks
Urinalysis - Week 11
Time Frame: 11 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
11 weeks
Urinalysis - Week 12
Time Frame: 12 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
12 weeks
Urinalysis - Week 13
Time Frame: 13 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
13 weeks
Urinalysis - Week 14
Time Frame: 14 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
14 weeks
Urinalysis - Week 15
Time Frame: 15 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
15 weeks
Urinalysis - Week 16
Time Frame: 16 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
16 weeks
Urinalysis - Week 17
Time Frame: 17 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
17 weeks
Urinalysis - Week 18
Time Frame: 18 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
18 weeks
Urinalysis - Week 19
Time Frame: 19 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
19 weeks
Urinalysis - Week 20
Time Frame: 20 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
20 weeks
Urinalysis - Week 21
Time Frame: 21 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
21 weeks
Urinalysis - Week 22
Time Frame: 22 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
22 weeks
Urinalysis - Week 23
Time Frame: 23 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
23 weeks
Urinalysis - Week 24
Time Frame: 24 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
24 weeks
Urinalysis - Week 25
Time Frame: 25 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
25 weeks
Urinalysis - Week 26
Time Frame: 26 weeks
Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
26 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
TLFB - Month 0 (Intake)
Time Frame: 1 day
Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
1 day
TLFB - Month 1
Time Frame: 1 month
Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
1 month
TLFB - Month 2
Time Frame: 2 months
Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
2 months
TLFB - Month 3
Time Frame: 3 months
Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
3 months
TLFB - Month 4
Time Frame: 4 months
Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
4 months
TLFB - Month 5
Time Frame: 5 months
Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
5 months
TLFB - Month 6
Time Frame: 6 months
Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
6 months
Treatment Continuation - Week 1
Time Frame: 1 week
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
1 week
Treatment Continuation - Week 2
Time Frame: 2 weeks
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
2 weeks
Treatment Continuation - Week 3
Time Frame: 3 weeks
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
3 weeks
Treatment Continuation - Week 4
Time Frame: 4 weeks
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
4 weeks
Treatment Continuation - Week 5
Time Frame: 5 weeks
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
5 weeks
Treatment Continuation - Week 6
Time Frame: 6 weeks
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
6 weeks
Treatment Continuation - Week 7
Time Frame: 7 weeks
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
7 weeks
Treatment Continuation - Week 8
Time Frame: 8 weeks
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
8 weeks
Treatment Continuation - Week 9
Time Frame: 9 weeks
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
9 weeks
Treatment Continuation - Week 10
Time Frame: 10 weeks
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
10 weeks
Treatment Continuation - Week 11
Time Frame: 11 weeks
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
11 weeks
Treatment Continuation - Week 12
Time Frame: 12 weeks
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
12 weeks
Treatment Continuation - Week 13
Time Frame: 13 weeks
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
13 weeks
Treatment Continuation - Week 14
Time Frame: 14 weeks
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
14 weeks
Treatment Continuation - Week 15
Time Frame: 15 weeks
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
15 weeks
Treatment Continuation - Week 16
Time Frame: 16 weeks
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
16 weeks
Treatment Continuation - Week 17
Time Frame: 17 weeks
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
17 weeks
Treatment Continuation - Week 18
Time Frame: 18 weeks
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
18 weeks
Treatment Continuation - Week 19
Time Frame: 19 weeks
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
19 weeks
Treatment Continuation - Week 20
Time Frame: 20 weeks
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
20 weeks
Treatment Continuation - Week 21
Time Frame: 21 weeks
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
21 weeks
Treatment Continuation - Week 22
Time Frame: 22 weeks
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
22 weeks
Treatment Continuation - Week 23
Time Frame: 23 weeks
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
23 weeks
Treatment Continuation - Week 24
Time Frame: 24 weeks
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
24 weeks
Treatment Continuation - Week 25
Time Frame: 25 weeks
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
25 weeks
Treatment Continuation - Week 26
Time Frame: 26 weeks
Binary variable if participant is still in treatment (yes/no). Survival analysis will determine if duration of treatment (i.e. time to treatment discontinuation) differs between study arms
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Arkansas

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrew James, Ph.D., University of Arkansas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 16, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 274084

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Persuant to NIH/NIDA policy for transparency and rigorous experimental design (NOT-MH-14-004, NOT-DA-14-007), all published data will be de-identified and made publicly available through clinical and neuroimaging repositories such as the ENIGMA Addiction Working Group, INDI, or OpenFMRI. To promote open science, data infrastructure will follow the HCP universal BIDS format.

IPD Sharing Time Frame

For each publication, relevant data and code will be shared at time of publication. Data and code will be available indefinitely.

IPD Sharing Access Criteria

Data and code will be shared to open science data repositories as described above. Data will be de-identified so that anyone may access it.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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