Boost Study 31380 (mHealth)

• Sponsor: NXTech (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05757453
• Collaborator: (none)
• Enrollment: 43
• Location: 1
• Arm: 1
• Actual Duration (Months): 3.9
• Patients Per Site Per Month: 11

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Addiction	Device: MHealth	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: BoostOne Study (MHealth)
• Actual Study Start Date: Apr 18, 2022
• Actual Primary Completion Date: Jul 30, 2022
• Actual Study Completion Date: Aug 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental MHealth group	Device: MHealth; Mobile application

Outcome Measures

Primary Outcome Measures

1. Interaction Engagement, as Assessed by Measured Usage Time [Total at 8 weeks]

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

2. Interaction Engagement, as Assessed by Interactions Completed [Total at 8 weeks]

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

Secondary Outcome Measures

1. Intervention Usability Rating, as Assessed by Likert User Experience Scale [Score at 8 weeks]

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

2. Treatment Progress Measure, as Assessed by TEA Score [Change over 8 weeks, assessed weekly (week 1 to week 8 change)]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PHNY	Astoria	New York	United States	11106

Sponsors and Collaborators

• NXTech

Investigators

• Principal Investigator: Alexis Vien, MD, PHNY

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NXTech
• ClinicalTrials.gov Identifier: NCT05757453
• Other Study ID Numbers: NX-31380
• First Posted: Mar 7, 2023
• Last Update Posted: Mar 7, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Behavior, Addictive

Study Results

No Results Posted as of Mar 7, 2023