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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-16

Study Completion Date

2028-09-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Smartphone

Intervention Type DEVICE

Adjunctive Smartphone app for improving MAT outcomes

Monitoring Only

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Smartphone

Adjunctive Smartphone app for improving MAT outcomes

Intervention Type DEVICE

Other Intervention Names

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OptiMAT, "Optimizing MAT"

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No