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

March 21, 2024 updated by: Alia Al-Tayyib, Denver Health and Hospital Authority

Linkage Navigation to Enhance Initiation and Engagement in Treatment for Opioid Use Disorder to Prevent Overdose

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80203
        • Denver Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
dedicated case management
Behavioral: Case management
dedicated case management to address social support needs
No Intervention: Usual care
usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention in treatment at 90 days
Time Frame: 90 days from treatment initiation
Defined by proportion of participants retained in care at 90 days, as measured by the total number of intakes where patient has continued to be engaged in medication assisted treatment at 90 days from start of treatment divided by the total number of intakes where patients linked to follow up dosing or prescription, for each arm.
90 days from treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Denver Health and Hospital Authority

Collaborators

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Alia Al-Tayyib, PhD, Denver Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2021

Primary Completion (Actual)

August 8, 2022

Study Completion (Actual)

September 29, 2023

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

March 10, 2021

First Posted (Actual)

March 15, 2021

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-2236
  • R01CE00300 (Other Grant/Funding Number: Centers for Disease Control and Prevention)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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