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Boost Study 31380 (mHealth)

Primary Purpose

Addiction

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

MHealth

About this trial

This is an interventional treatment trial for Addiction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

PHNY

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

MHealth group

Outcomes

Primary Outcome Measures

Interaction Engagement, as Assessed by Measured Usage Time

Usage Time (units in minutes, range 0 to unbound)

Interaction Engagement, as Assessed by Interactions Completed

Interactions Completed (units in counts of interactions, range 0 to unbound)

Secondary Outcome Measures

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)

Treatment Progress Measure, as Assessed by TEA Score

Patient-centered instrument for evaluating progress in recovery from addiction, TEA Score (scale range 4 to 40, higher better)

Full Information

NCT ID

NCT05757453

First Posted

January 31, 2023

Last Updated

July 31, 2023

Sponsor

NXTech

1. Study Identification

Unique Protocol Identification Number

NCT05757453

Brief Title

Boost Study 31380 (mHealth)

Official Title

BoostOne Study (MHealth)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

April 18, 2022 (Actual)

Primary Completion Date

March 1, 2023 (Actual)

Study Completion Date

March 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NXTech

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 application 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Addiction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

MHealth group

Intervention Type

Device

Intervention Name(s)

MHealth

Intervention Description

Mobile application

Primary Outcome Measure Information:

Title

Interaction Engagement, as Assessed by Measured Usage Time

Description

Usage Time (units in minutes, range 0 to unbound)

Time Frame

Total at 8 weeks

Title

Interaction Engagement, as Assessed by Interactions Completed

Description

Interactions Completed (units in counts of interactions, range 0 to unbound)

Time Frame

Total at 8 weeks

Secondary Outcome Measure Information:

Title

Intervention Usability Rating, as Assessed by Likert User Experience Scale

Description

Subjective scoring of design and function usability, Likert User Experience Scale (score range 1-5, higher better)

Time Frame

Score at 8 weeks

Title

Treatment Progress Measure, as Assessed by TEA Score

Description

Patient-centered instrument for evaluating progress in recovery from addiction, TEA Score (scale range 4 to 40, higher better)

Time Frame

Change over 8 weeks, assessed weekly (week 1 to week 8 change)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexis Vien, MD

Organizational Affiliation

PHNY

Official's Role

Principal Investigator

Facility Information:

Facility Name

PHNY

City

Astoria

State/Province

New York

ZIP/Postal Code

11106

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Boost Study 31380 (mHealth)

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