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

NCT05336188 | Recruiting DMC FDA Device

• 1 other identifier: 274084
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid-Related Disorders; Mobile Applications; Opiate Substitution Treatment; Magnetic Resonance Imaging; Craving; Attentional Bias; Ecological Momentary Assessment

Outcome Measures

Primary Outcomes (27)

• Urinalysis - Week 0 (Intake)

  Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

  1 day

• Urinalysis - Week 1

  Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

  1 week

• Urinalysis - Week 2

  Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

  2 weeks

• Urinalysis - Week 3

  Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

  3 weeks

• Urinalysis - Week 4

  Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

  4 weeks

• Urinalysis - Week 5

  Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

  5 weeks

• Urinalysis - Week 6

  Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

  6 weeks

• Urinalysis - Week 7

  Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

  7 weeks

• Urinalysis - Week 8

  Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

  8 weeks

• Urinalysis - Week 9

  Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

  9 weeks

• Urinalysis - Week 10

  Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

  10 weeks

• Urinalysis - Week 11

  Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

  11 weeks

• Urinalysis - Week 12

  Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

  12 weeks

• Urinalysis - Week 13

  Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

  13 weeks

• Urinalysis - Week 14

  Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

  14 weeks

• Urinalysis - Week 15

  Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

  15 weeks

• Urinalysis - Week 16

  Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

  16 weeks

• Urinalysis - Week 17

  Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

  17 weeks

• Urinalysis - Week 18

  Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

  18 weeks

• Urinalysis - Week 19

  Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

  19 weeks

• Urinalysis - Week 20

  Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

  20 weeks

• Urinalysis - Week 21

  Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

  21 weeks

• Urinalysis - Week 22

  Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

  22 weeks

• Urinalysis - Week 23

  Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

  23 weeks

• Urinalysis - Week 24

  Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

  24 weeks

• Urinalysis - Week 25

  Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

  25 weeks

• Urinalysis - Week 26

  Percent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

  26 weeks

Secondary Outcomes (33)

• TLFB - Month 0 (Intake)

  1 day

• TLFB - Month 1

  1 month

• TLFB - Month 2

  2 months

• TLFB - Month 3

  3 months

• TLFB - Month 4

  4 months

Study Arms (2)

Smartphone

EXPERIMENTAL

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

Monitoring Only

NO INTERVENTION

Participants randomized into the Monitoring Only arm would undergo treatment as usual (TAU) but without the smartphone app.

Interventions

Smartphone DEVICE

Adjunctive Smartphone app for improving MAT outcomes

Also known as: OptiMAT, "Optimizing MAT"

Smartphone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• (MRI) Pregnancy: A positive test for pregnancy prior to fMRI would exclude participation, due to unknown effect of high-field MRI on developing fetus.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

Brain Imaging Research Center

Little Rock, Arkansas, 72227, United States

RECRUITING

Related Publications (3)

• Bollinger M, Thompson RG Jr, Mancino MJ, Hasin DS, James GA. Geospatial ecological momentary assessment (GEMA) for opioid use disorder: Protocol for a just-in-time adaptive intervention. J Subst Use Addict Treat. 2026 Mar 19;186:209946. doi: 10.1016/j.josat.2026.209946. Online ahead of print.

  PMID: 41862055 BACKGROUND

• Thompson RG Jr, Bollinger M, Mancino MJ, Hasin D, Han X, Bush KA, Kilts CD, James GA. Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. Trials. 2023 Apr 4;24(1):255. doi: 10.1186/s13063-023-07213-3.

  PMID: 37016394 RESULT

• Thompson RG Jr, Bollinger M, Mancino M, Hasin D, Han X, Bush KA, Kilts CD, James GA. Smartphone intervention to optimize medication assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. Res Sq [Preprint]. 2023 Feb 15:rs.3.rs-2511936. doi: 10.21203/rs.3.rs-2511936/v1.

  PMID: 36824884 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Andrew James, Ph.D.

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew James, Ph.D.

CONTACT

501-526-8345; GAJames@uams.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Primary outcome will be evaluated by co-I Dr. Thompson and staff biostatistician, who will remain blind to participant group membership. Since intervention involves daily use of a smartphone, participants will not be blind to group membership. Care providers all will be blind to participants' group membership. PI Dr. James and/or study staff will enroll, provide training in smartphone use, and troubleshoot technical issues, thus will not be blind to group membership.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to one of two arms: a Monitor Only arm (aka treatment-as-usual, MAT only) and a Smartphone arm (aka OptiMAT plus MAT).

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 20, 2022
• Study Start: May 16, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: For each publication, relevant data and code will be shared at time of publication. Data and code will be available indefinitely.
• 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.

Locations

US (1)