Needle-X: Usability Testing of a Smartphone Application

December 30, 2019 updated by: NYU Langone Health
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

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

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Needle X
Smartphone application application to enhance access to sterile needles, naloxone overdose kits, and addiction treatment programs in New York City.
Behavioral: Smartphone Application
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Needle-X application
Time Frame: 12 Months
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.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Babak Tofighi, MD, NYU Langone Health

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 (Anticipated)

February 1, 2019

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

August 14, 2018

First Submitted That Met QC Criteria

September 7, 2018

First Posted (Actual)

September 11, 2018

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 30, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-00652

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Violates the ethical conduct of technology based intervention research for an early-stage intervention development project.

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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