Boost Study 31380 (mHealth)

Phase 1

Completed

• Conditions: Addiction
• Interventions: Device: MHealth

• Registration Number: NCT05757453
• Lead Sponsor: NXTech

Brief Summary

The purpose of this research is to examine the potential for a new software-based behavioral support approach, for individuals with opioid use disorder, as an addition to usual care.

Detailed Description

The purpose of this study is to examine the potential for a novel computer-based approach to mitigate the symptoms of opioid use disorder as part of a comprehensive treatment program. The study is designed as a single-arm field-test of cognitive training for individuals under supervised medical treatment for opioid use disorder. A custom and proprietary smartphone package (mHealth platform) comprises the intervention available to enrolled subjects for interaction over the study period. Commercial mobile devices serve as information presentation and data recording instruments. Additional outcome measures incorporate subject-reported data.

Study Timeline

• Study Start: 2022-04-18
• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-03-03
• Study First Posted: 2023-03-07
• Primary Completion: 2023-03-30
• Study Completion: 2023-03-30
• Results First Submitted: 2024-05-09
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-15
• Last Update Submitted: 2024-12-15
• Results First Posted: 2024-12-18
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Age 18-65 years
• Diagnosis of opioid use disorder
• Experiencing symptoms multiple times per week
• Familiar with smartphone usage

Exclusion Criteria

• None specified

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	MHealth	MHealth group

Primary Outcome Measures

Name	Time	Method
Interaction Engagement, as Assessed by Interactions Completed	At 8 weeks	Interactions Completed (interactions completed, range 0 to unbound)

Secondary Outcome Measures

Name	Time	Method
Intervention Usability Rating, as Assessed by Likert User Experience Scale	At 8 weeks	Subjective scoring of design and function usability, Likert User Experience Scale (score range 1-5, higher better)
Treatment Progress Measure, as Assessed by TEA Score	At 8 weeks	Patient-Centered instrument for evaluating progress, TEA Score (scale range 4 to 40, higher better), assessed weekly for 8 weeks with week 8 reported

Trial Locations

Locations (1)

PHNY; 🇺🇸 Astoria, New York, United States