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Enrolling by invitation NCT05336188

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

No phase Interventional Opioid-Related Disorders Mobile Applications Opiate Substitution Treatment Magnetic Resonance Imaging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Smartphone.
Who it may be relevant to
Registry conditions: Opioid-Related Disorders, Mobile Applications, Opiate Substitution Treatment, Magnetic Resonance Imaging. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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.

Interventions

  • Device Smartphone
    Adjunctive Smartphone app for improving MAT outcomes

Primary outcome measures

  • Urinalysis - Week 0 (Intake) [Time frame: 1 day]
  • Urinalysis - Week 1 [Time frame: 1 week]
  • Urinalysis - Week 2 [Time frame: 2 weeks]
  • Urinalysis - Week 3 [Time frame: 3 weeks]
  • Urinalysis - Week 4 [Time frame: 4 weeks]
  • Urinalysis - Week 5 [Time frame: 5 weeks]
  • Urinalysis - Week 6 [Time frame: 6 weeks]
  • Urinalysis - Week 7 [Time frame: 7 weeks]
  • Urinalysis - Week 8 [Time frame: 8 weeks]
  • Urinalysis - Week 9 [Time frame: 9 weeks]
Secondary outcome measures (12)
  • TLFB - Month 0 (Intake) [Time frame: 1 day]
  • TLFB - Month 1 [Time frame: 1 month]
  • TLFB - Month 2 [Time frame: 2 months]
  • TLFB - Month 3 [Time frame: 3 months]
  • TLFB - Month 4 [Time frame: 4 months]
  • TLFB - Month 5 [Time frame: 5 months]
  • TLFB - Month 6 [Time frame: 6 months]
  • Treatment Continuation - Week 1 [Time frame: 1 week]
  • Treatment Continuation - Week 2 [Time frame: 2 weeks]
  • Treatment Continuation - Week 3 [Time frame: 3 weeks]
  • Treatment Continuation - Week 4 [Time frame: 4 weeks]
  • Treatment Continuation - Week 5 [Time frame: 5 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Brain Imaging Research Center — Little Rock

Publications

  • 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 Jul;186:209946. doi: 10.1016/j.josat.2026.209946. Epub 2026 Mar 19. PMID 41862055
  • 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
  • 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

Identifiers

NCT: NCT05336188 · 274084

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗