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Recruiting Phase 2 NCT05336188

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

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Trial Parameters

Condition Opioid-Related Disorders
Sponsor University of Arkansas
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 255
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-05-16
Completion 2027-09-30
Interventions
Smartphone

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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.

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

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