NCT03665298

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

9 months

First QC Date

August 14, 2018

Last Update Submit

December 30, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 Months

Study Arms (1)

Needle X

EXPERIMENTAL

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

Behavioral: Smartphone Application

Interventions

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.

Needle X

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Babak Tofighi, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2018

First Posted

September 11, 2018

Study Start

February 1, 2019

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

January 2, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

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

Locations