Back to resultsNeedle-X: Usability Testing of a Smartphone Application
Primary Purpose
Opioid Dependence
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smartphone Application
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Dependence
Eligibility Criteria
Inclusion Criteria:
- Fluent in spoken and written English;
- Meets or has previously met DSM-5 criteria for current opioid use disorder, of at least moderate severity;
- Owns or has owned a smartphone
Exclusion Criteria:
- Any patient who does not meet the inclusion criteria as above, is clinically unstable per the unit admitting physicians, refuses to participate in the study, or is cognitively impaired.
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Needle X
Arm Description
Smartphone application application to enhance access to sterile needles, naloxone overdose kits, and addiction treatment programs in New York City.
Outcomes
Primary Outcome Measures
Feasibility of Needle-X application
number of patients enrolled, as this study will include a single interaction, at which point the patient will no longer be part of the study.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03665298
Brief Title
Needle-X: Usability Testing of a Smartphone Application
Official Title
Needle-X: Usability Testing of a Smartphone Application
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Withdrawn
Why Stopped
The study was never started by the responsible party (medical student who is no longer at the institution).
Study Start Date
February 2019 (Anticipated)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Mobile health interventions offer a longitudinal approach to reducing the burden of substance use disorders and may stem the rise of the opioid overdose epidemic. Smartphone applications are one of the most popular mobile phone features nationally, among patients in addiction treatment, and among criminal justice involved (CJI) patients enrolled in addiction treatment. This research conducted at Bellevue Hospital's inpatient detoxification program established attitudes and self-reported behaviors favorable to theoretical smartphone applications addressing opioid use, HIV, and HCV prevention and management strategies. This study aims to assess the feasibility and usability of a smartphone application to enhance access to sterile needles, naloxone overdose kits, and addiction treatment programs in New York City.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Needle X
Arm Type
Experimental
Arm Description
Smartphone application application to enhance access to sterile needles, naloxone overdose kits, and addiction treatment programs in New York City.
Intervention Type
Behavioral
Intervention Name(s)
Smartphone Application
Intervention Description
App that helps patients find syringe exchange programs, safe way to dispose of needles, access to naloxone kits and access to free medical care and addiction treatment programs.
Primary Outcome Measure Information:
Title
Feasibility of Needle-X application
Description
number of patients enrolled, as this study will include a single interaction, at which point the patient will no longer be part of the study.
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Fluent in spoken and written English;
Meets or has previously met DSM-5 criteria for current opioid use disorder, of at least moderate severity;
Owns or has owned a smartphone
Exclusion Criteria:
Any patient who does not meet the inclusion criteria as above, is clinically unstable per the unit admitting physicians, refuses to participate in the study, or is cognitively impaired.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Babak Tofighi, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Violates the ethical conduct of technology based intervention research for an early-stage intervention development project.
Learn more about this trial
Needle-X: Usability Testing of a Smartphone Application
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