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Boost Study 31380 (mHealth)

NCT ID: NCT05757453

Last Updated: 2024-12-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-18

Study Completion Date

2023-03-30

Brief Summary

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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.

Detailed Description

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The purpose of this study is to examine the potential for a novel computer-based approach to mitigate the symptoms of opioid use disorder as part of a comprehensive treatment program. The study is designed as a single-arm field-test of cognitive training for individuals under supervised medical treatment for opioid use disorder. A custom and proprietary smartphone package (mHealth platform) comprises the intervention available to enrolled subjects for interaction over the study period. Commercial mobile devices serve as information presentation and data recording instruments. Additional outcome measures incorporate subject-reported data.

Conditions

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Addiction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

mHealth group

Group Type EXPERIMENTAL

mHealth

Intervention Type DEVICE

Mobile platform

Interventions

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mHealth

Mobile platform

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- None specified
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

NXTech

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexis Vien, MD

Role: PRINCIPAL_INVESTIGATOR

PHNY

Locations

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PHNY

Astoria, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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1R43DA051270

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NX-31380

Identifier Type: -

Identifier Source: org_study_id