Boost Study 31380 (mHealth)

Addiction Clinical Trial

Official title:

BoostOne Study (MHealth)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05757453
• Other study ID #: NX-31380
• Status: Completed
• Phase: Phase 1
• Start date: April 18, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: July 2023
• Source: NXTech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 30, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Addiction
• Behavior, Addictive

Intervention

Device:
• MHealth
Mobile application

Locations

Country	Name	City	State
United States	PHNY	Astoria	New York

Sponsors (1)

Lead Sponsor	Collaborator
NXTech

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interaction Engagement, as Assessed by Measured Usage Time	Usage Time (units in minutes, range 0 to unbound)	Total at 8 weeks
Primary	Interaction Engagement, as Assessed by Interactions Completed	Interactions Completed (units in counts of interactions, range 0 to unbound)	Total at 8 weeks
Secondary	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)	Score at 8 weeks
Secondary	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)	Change over 8 weeks, assessed weekly (week 1 to week 8 change)