Skip to content

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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05336188
Enrollment
336
Registered
2022-04-20
Start date
2023-05-16
Completion date
2028-09-30
Last updated
2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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

DEVICESmartphone

Adjunctive Smartphone app for improving MAT outcomes

Sponsors

University of Arkansas
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Masking description

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.

Intervention model description

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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:

Design outcomes

Primary

MeasureTime frameDescription
Urinalysis - Week 0 (Intake)1 dayPercent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 11 weekPercent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 22 weeksPercent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 33 weeksPercent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 44 weeksPercent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 55 weeksPercent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 66 weeksPercent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 77 weeksPercent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 88 weeksPercent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 99 weeksPercent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 1010 weeksPercent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 1111 weeksPercent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 1212 weeksPercent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 1313 weeksPercent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 1414 weeksPercent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 1515 weeksPercent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 1616 weeksPercent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 1717 weeksPercent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 1818 weeksPercent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 1919 weeksPercent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 2020 weeksPercent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 2121 weeksPercent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 2222 weeksPercent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 2323 weeksPercent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 2424 weeksPercent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 2525 weeksPercent of weekly urinalysis tests positive for opioid metabolite other than Suboxone
Urinalysis - Week 2626 weeksPercent of weekly urinalysis tests positive for opioid metabolite other than Suboxone

Secondary

MeasureTime frameDescription
TLFB - Month 0 (Intake)1 dayDays per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
TLFB - Month 11 monthDays per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
TLFB - Month 22 monthsDays per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
TLFB - Month 33 monthsDays per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
TLFB - Month 44 monthsDays per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
TLFB - Month 55 monthsDays per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
TLFB - Month 66 monthsDays per Month of self-reported opioid misuse from monthly TimeLine FollowBack calendar over past 30 days
Treatment Continuation - Week 11 weekBinary 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
Treatment Continuation - Week 22 weeksBinary 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
Treatment Continuation - Week 33 weeksBinary 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
Treatment Continuation - Week 44 weeksBinary 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
Treatment Continuation - Week 55 weeksBinary 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
Treatment Continuation - Week 66 weeksBinary 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
Treatment Continuation - Week 77 weeksBinary 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
Treatment Continuation - Week 88 weeksBinary 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
Treatment Continuation - Week 99 weeksBinary 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
Treatment Continuation - Week 1010 weeksBinary 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
Treatment Continuation - Week 1111 weeksBinary 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
Treatment Continuation - Week 1212 weeksBinary 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
Treatment Continuation - Week 1313 weeksBinary 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
Treatment Continuation - Week 1414 weeksBinary 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
Treatment Continuation - Week 1515 weeksBinary 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
Treatment Continuation - Week 1616 weeksBinary 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
Treatment Continuation - Week 1717 weeksBinary 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
Treatment Continuation - Week 1818 weeksBinary 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
Treatment Continuation - Week 1919 weeksBinary 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
Treatment Continuation - Week 2020 weeksBinary 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
Treatment Continuation - Week 2121 weeksBinary 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
Treatment Continuation - Week 2222 weeksBinary 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
Treatment Continuation - Week 2323 weeksBinary 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
Treatment Continuation - Week 2424 weeksBinary 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
Treatment Continuation - Week 2525 weeksBinary 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
Treatment Continuation - Week 2626 weeksBinary 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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAndrew James, Ph.D.

University of Arkansas

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026