Boost Study 31380 (mHealth)

BoostOne Study (MHealth)

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.

Study Overview

• Status: Completed
• Conditions: Addiction
• Intervention / Treatment: Device: mHealth

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 Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Astoria, New York, United States, 11106
      • PHNY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; mHealth group	Device: mHealth; Mobile platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interaction Engagement, as Assessed by Interactions Completed	Interactions Completed (interactions completed, range 0 to unbound)	At 8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NXTech
• Collaborators: National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Alexis Vien, MD, PHNY

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2022
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Compulsive Behavior; Impulsive Behavior; Behavior, Addictive
• Other Study ID Numbers: NX-31380; 1R43DA051270 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes