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Needle-X: Usability Testing of a Smartphone Application

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ClinicalTrials.gov Identifier: NCT03665298
Recruitment Status : Not yet recruiting
First Posted : September 11, 2018
Last Update Posted : January 4, 2019
Sponsor:
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)
Estimated Enrollment : 65 participants
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

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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
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.

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 ClinicalTrials.gov identifier (NCT number): NCT03665298


Contacts
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Contact: Chemi Chemi 646 501 7743 Chemi.Chemi@nyumc.org

Locations
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United States, New York
New York University School of Medicine Not yet recruiting
New York, New York, United States, 10016
Contact: Chemi Chemi    646-501-7743    chemi.chemi@nyumc.org   
Principal Investigator: Babak Tofighi, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Babak Tofighi, MD NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03665298     History of Changes
Other Study ID Numbers: 18-00652
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 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