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

Opioid-use Disorder Clinical Trial

— ConNECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04797962
• Other study ID #: 20-2236
• Secondary ID: R01CE00300
• Status: Completed
• Phase: N/A
• Start date: March 30, 2021
• Est. completion date: September 29, 2023

Study information

• Verified date: March 2024
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: September 29, 2023
• Est. primary completion date: August 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders

Intervention

Behavioral:
• Case management
dedicated case management to address social support needs

Locations

Country	Name	City	State
United States	Denver Health	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention in treatment at 90 days	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