NCT05757453

Brief Summary

The purpose of this research is to examine the potential for a new software-based behavioral support approach, for individuals with opioid use disorder, as an addition to usual care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 18, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

December 18, 2024

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

12 months

First QC Date

January 31, 2023

Results QC Date

May 9, 2024

Last Update Submit

December 15, 2024

Conditions

Addiction

Outcome Measures

Primary Outcomes (1)

  • Interaction Engagement, as Assessed by Interactions Completed

    Interactions Completed (interactions completed, range 0 to unbound)

    At 8 weeks

Secondary Outcomes (2)

  • Intervention Usability Rating, as Assessed by Likert User Experience Scale

    At 8 weeks

  • Treatment Progress Measure, as Assessed by TEA Score

    At 8 weeks

Study Arms (1)

Experimental

EXPERIMENTAL

mHealth group

Device: mHealth

Interventions

mHealthDEVICE

Mobile platform

Experimental

Eligibility Criteria

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

You may qualify if:

  • Age 18-65 years
  • Diagnosis of opioid use disorder
  • Experiencing symptoms multiple times per week
  • Familiar with smartphone usage

You may not qualify if:

  • \- None specified

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PHNY

Astoria, New York, 11106, United States

Location

MeSH Terms

Conditions

Behavior, Addictive

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehavior

Results Point of Contact

Title
Principal Investigator for Study 31380
Organization
NXTech
external+studyinvestigator@nxtech.co
7814721140

Study Officials

  • Alexis Vien, MD

    PHNY

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2023

First Posted

March 7, 2023

Study Start

April 18, 2022

Primary Completion

March 30, 2023

Study Completion

March 30, 2023

Last Updated

December 18, 2024

Results First Posted

December 18, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

Locations

US(1)