NCT06311838

Building Social and Structural Connections for the Prevention of Opioid Use Disorder Among Youth Experiencing Homelessness

Recruiting now NA Last updated 22 September 2025

What this trial tests

NA trial testing Motivational Interviewing/Community Reinforcement Approach (MI/CRA) in Opioid Use Disorder in 300 participants. Currently enrolling.

Timeline

6 May 2024

Primary endpoint
1 December 2028

1 December 2029

Quick facts

Lead sponsor	Ohio State University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	300
Start date	6 May 2024
Primary completion	1 December 2028
Estimated completion	1 December 2029
Sites	2 locations across United States

Drugs / interventions tested

• Motivational Interviewing/Community Reinforcement Approach (MI/CRA)
• Strengths-Based Outreach and Advocacy (SBOA )
• Services as Usual (SAU)

Conditions studied

• Opioid Use Disorder — all drugs for Opioid Use Disorder →
• Dual Diagnosis — all drugs for Dual Diagnosis →
• Housing Problems — all drugs for Housing Problems →
• Mental Disorder in Adolescence — all drugs for Mental Disorder in Adolescence →

Sponsor

Ohio State University

Who can join

Adults 14 to 24, any sex, with Opioid Use Disorder or Dual Diagnosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Homelessness severely affects health and well-being and is particularly negative for youth. Between 70-95% of youth experiencing homelessness (YEH) report problem substance use and 66-89% have a mental health disorder. Youth appear to be at greater risk for living on the streets or being homeless than adults and are more vulnerable to long term consequences of homelessness. Multiple social determinants of health (SDOH) are uniquely associated with homelessness, driving substance use and adverse mental health consequences. However, limited research has identified pragmatic interventions that have a long-term ameliorating impact on the complex, multi-symptomatic issues among these youth. This study overcomes prior gaps in research through testing a multi-component comprehensive prevention intervention targeting SDOH that may affect biopsychosocial health indicators and longer-term health outcomes. In partnership with a drop-in center for YEH, youth between the ages of 14 to 24 years, will be engaged and randomly assigned to conditions using a dismantling design so that essential intervention components can be efficiently identified. In particular, youth (N = 300) will be randomly assigned to a) Motivational Interviewing/Community Reinforcement Approach + Services as Usual (MI/CRA + SAU, n = 80), b) Strengths-Based Outreach and Advocacy + Services As Usual (SBOA + SAU, n = 80), c) MI/CRA + SBOA + SAU (n = 80) or d) SAU (n=60) through the drop-in center. In order to assess the longer-term prevention effects on substance use, mental health and other outcomes, all youth will be assessed at baseline and at 3, 6, 12, 18 and 24-months post-baseline. The primary goal of this study is to establish the impact of a comprehensive intervention embedded within a system that serves YEH, a community drop-in center, on youth's opioid misuse and disorder, other substance misuse and disorders, mental health diagnoses, and other targeted outcomes. This study will offer unique information on the physiological and psychological stress pathways underlying change for specific subgroups of youth along with cost estimates to inform future implementation efforts in drop-in centers around the country.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.