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Needle-X: Usability Testing of a Smartphone Application

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03665298
Recruitment Status : Withdrawn (The study was never started by the responsible party (medical student who is no longer at the institution).)
First Posted : September 11, 2018
Last Update Posted : January 2, 2020
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Opioid Dependence Behavioral: Smartphone Application Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Needle-X: Usability Testing of a Smartphone Application
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03665298

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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
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Principal Investigator: Babak Tofighi, MD NYU Langone Health
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Responsible Party: NYU Langone Health Identifier: NCT03665298    
Other Study ID Numbers: 18-00652
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Violates the ethical conduct of technology based intervention research for an early-stage intervention development project.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders