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Clinical Trials/NCT04797962
NCT04797962CompletedNot Applicable

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

Denver Health and Hospital Authority1 site in 1 country102 target enrollmentStarted: March 30, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
102
Locations
1
Primary Endpoint
Retention in treatment at 90 days

Study Overview

Brief 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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Intervention

Experimental

dedicated case management

Intervention: Case management (Behavioral)

Usual care

No Intervention

usual care

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alia Al-Tayyib

Associate Research Scientist

Denver Health and Hospital Authority

Study Sites (1)

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