- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05757453
Boost Study 31380 (mHealth)
July 31, 2023 updated by: NXTech
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
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 Type
Interventional
Enrollment (Actual)
43
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Astoria, New York, United States, 11106
- PHNY
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
MHealth group
|
Mobile application
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interaction Engagement, as Assessed by Measured Usage Time
Time Frame: Total at 8 weeks
|
Usage Time (units in minutes, range 0 to unbound)
|
Total at 8 weeks
|
Interaction Engagement, as Assessed by Interactions Completed
Time Frame: Total at 8 weeks
|
Interactions Completed (units in counts of interactions, range 0 to unbound)
|
Total at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention Usability Rating, as Assessed by Likert User Experience Scale
Time Frame: Score at 8 weeks
|
Subjective scoring of design and function usability, Likert User Experience Scale (score range 1-5, higher better)
|
Score at 8 weeks
|
Treatment Progress Measure, as Assessed by TEA Score
Time Frame: 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)
|
Change over 8 weeks, assessed weekly (week 1 to week 8 change)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alexis Vien, MD, PHNY
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 18, 2022
Primary Completion (Actual)
March 1, 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)
August 1, 2023
Last Update Submitted That Met QC Criteria
July 31, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NX-31380
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
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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