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Enrolling by Invitation

NCT Number: NCT05336188

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

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.

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Key information

Conditions

Opioid-related Disorders Attentional Bias Chemically-Induced Disorders Craving Ecological Momentary Assessment Magnetic Resonance Imaging Mental Disorders Mobile Applications Narcotic-Related Disorders Opiate Substitution Treatment Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brain Imaging Research Center

Little Rock, Arkansas, 72227, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

smartphone

Device

Adjunctive Smartphone app for improving MAT outcomes

Other names: OptiMAT, "Optimizing MAT"

Primary outcomes

  1. Urinalysis - Week 0 (Intake)

    Time frame: 1 day

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

  2. Urinalysis - Week 1

    Time frame: 1 week

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

  3. Urinalysis - Week 2

    Time frame: 2 weeks

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

  4. Urinalysis - Week 3

    Time frame: 3 weeks

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

  5. Urinalysis - Week 4

    Time frame: 4 weeks

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

  6. Urinalysis - Week 5

    Time frame: 5 weeks

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

  7. Urinalysis - Week 6

    Time frame: 6 weeks

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

  8. Urinalysis - Week 7

    Time frame: 7 weeks

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

  9. Urinalysis - Week 8

    Time frame: 8 weeks

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

  10. Urinalysis - Week 9

    Time frame: 9 weeks

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

  11. Urinalysis - Week 10

    Time frame: 10 weeks

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

  12. Urinalysis - Week 11

    Time frame: 11 weeks

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

  13. Urinalysis - Week 12

    Time frame: 12 weeks

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

  14. Urinalysis - Week 13

    Time frame: 13 weeks

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

  15. Urinalysis - Week 14

    Time frame: 14 weeks

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

  16. Urinalysis - Week 15

    Time frame: 15 weeks

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

  17. Urinalysis - Week 16

    Time frame: 16 weeks

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

  18. Urinalysis - Week 17

    Time frame: 17 weeks

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

  19. Urinalysis - Week 18

    Time frame: 18 weeks

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

  20. Urinalysis - Week 19

    Time frame: 19 weeks

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

  21. Urinalysis - Week 20

    Time frame: 20 weeks

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

  22. Urinalysis - Week 21

    Time frame: 21 weeks

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

  23. Urinalysis - Week 22

    Time frame: 22 weeks

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

  24. Urinalysis - Week 23

    Time frame: 23 weeks

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

  25. Urinalysis - Week 24

    Time frame: 24 weeks

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

  26. Urinalysis - Week 25

    Time frame: 25 weeks

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

  27. Urinalysis - Week 26

    Time frame: 26 weeks

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

Secondary outcomes

  1. 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

  2. TLFB - Month 1

    Time frame: 1 month

    Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days

  3. TLFB - Month 2

    Time frame: 2 months

    Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days

  4. TLFB - Month 3

    Time frame: 3 months

    Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days

  5. TLFB - Month 4

    Time frame: 4 months

    Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days

  6. TLFB - Month 5

    Time frame: 5 months

    Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days

  7. TLFB - Month 6

    Time frame: 6 months

    Days per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Apr 20, 2022
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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