Connection, Navigation, Engagement in Care and Treatment for Opioid Use Disorder

NCT ID: NCT04797962

Last Updated: 2024-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-30

Study Completion Date

2023-09-29

Brief Summary

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The overarching goal of the study is to develop, pilot, and evaluate an intervention that aims to retain patients who initiate buprenorphine at Denver Health in ongoing treatment for opioid use disorder.

Detailed Description

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Initiating patients identified with opioid use disorder in hospital settings onto buprenorphine is a relatively new strategy to prevent overdose. While the literature is beginning to amass showing the effectiveness of this strategy for initiating people into treatment, a dearth of data to describe how well people are maintained in treatment remains. The current research project aims to 1) develop an intervention to enhance engagement and retention in treatment for individuals with opioid use disorder who initiate buprenorphine at Denver Health and 2) assess acceptability, feasibility, and initial efficacy of an intervention to enhance engagement and retention in treatment for individuals with opioid disorder compared to usual care.

Conditions

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Opioid-use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

dedicated case management

Group Type EXPERIMENTAL

Case management

Intervention Type BEHAVIORAL

dedicated case management to address social support needs

Usual care

usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Case management

dedicated case management to address social support needs

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18 years and older
* inducted onto buprenorphine at Denver Health
* successfully completed an intake visit at Denver Health's Outpatient Behavioral Health Services clinic.

Exclusion Criteria

* unable to provide informed consent
* unable to provide detailed contact information
* previously enrolled in the current study
* pregnant women will be excluded given that they are a priority treatment population and receive special services
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Denver Health and Hospital Authority

OTHER

Sponsor Role lead

Responsible Party

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Alia Al-Tayyib

Associate Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alia Al-Tayyib, PhD

Role: PRINCIPAL_INVESTIGATOR

Denver Health

Locations

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Denver Health

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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R01CE00300

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20-2236

Identifier Type: -

Identifier Source: org_study_id

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