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Completed

NCT Number: NCT05757453

Boost Study 31380 (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.

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Key information

Conditions

Addiction Behavior Behavior, Addictive Compulsive Behavior Impulsive Behavior

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PHNY

Astoria, New York, 11106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mHealth

Device

Mobile platform

Primary outcomes

  1. Interaction Engagement, as Assessed by Interactions Completed

    Time frame: At 8 weeks

    Interactions Completed (interactions completed, range 0 to unbound)

Secondary outcomes

  1. Intervention Usability Rating, as Assessed by Likert User Experience Scale

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

NXTech

Industry

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Official study title

BoostOne Study (MHealth)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 7, 2023
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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