NCT04135703

Brief Summary

Homeless youth have a much higher rate of substance use than non-homeless peers with evidence suggesting that homeless youth have the highest rates of opioid use among youth subgroups in the country (Brands et al., 2005); heroin using homeless youth also appear to have the highest rates of IV drug use and HIV (Rhoades et al., 2014). Given the high rates of opioid use, exposure to violence, mental and physical health challenges, and high rates of mortality in homeless youth, it is surprising that no study to date utilizes a randomized controlled design to test prevention of opioid and other drug use among this vulnerable population. Resolution of youth homelessness through housing and prevention services, often referred to as "Housing First", as proposed in the current study, has great potential to reduce the likelihood for the development of an opioid use disorder as well as other problem behaviors associated with living on the streets. However, only 20-30% of homeless youth samples report ever having stayed at a crisis shelter, 9% report having ever accessed mental health services, and 15% report ever having received substance use treatment (Ray, 2006) indicating a need to reach and engage youth in services that are feasible and acceptable. This study will provide essential information for researchers and providers on the efficacy of housing + opioid and related risk prevention services in an RCT on opioid use, how moderators affect the response, and mechanisms underlying change.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 23, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

June 23, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2024

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 15, 2025

Completed
Last Updated

September 15, 2025

Status Verified

January 1, 2025

Enrollment Period

3.9 years

First QC Date

October 20, 2019

Results QC Date

September 11, 2025

Last Update Submit

September 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Frequency (% Days) of Opioid Use in Prior 3 Months

    frequency (% days in prior 90) of opioid use is measured at baseline, 3, 6, 9 and 12 months post-baseline

    12 months

Study Arms (2)

Risk Prevention Services +Housing

EXPERIMENTAL

Opioid and related prevention services including Strengths-Based Outreach and Advocacy (SBOA), MI, HIV risk and suicide prevention (CTSP) as well as rental and utility assistance for 6 months.

Behavioral: Risk Prevention Services + Housing

Risk Prevention Services Only

EXPERIMENTAL

Opioid and related prevention services including Strengths-Based Outreach and Advocacy (SBOA), MI, HIV risk and suicide prevention (CTSP).

Behavioral: Risk Prevention Services Only

Interventions

opioid and related prevention services in addition to 6 months of rental assistance

Risk Prevention Services +Housing

opioid and related prevention services for 6 months

Risk Prevention Services Only

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ages of 18 to 24 years
  • meets McKinney-Vento definition of homeless
  • fails to meet DSM 5 criteria for Opioid Use Disorder as assessed by the SCID

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (4)

  • Kuklinski MR, Gibbons BJ, Bowser DM, McCollister KE, Smart R, Dunlap LJ, Shenkar E, Bonar EE, Boomer T, Campbell M, Fiellin LE, Hutton DW, Rao V, Saldana L, Su K, Walton MA, Yilmazer T. Investing in Interventions to Prevent Opioid Use Disorder in Adolescents and Young Adults: Start-up Costs from NIDA's HEAL Prevention Initiative. Prev Sci. 2025 Nov;26(7):1045-1055. doi: 10.1007/s11121-025-01835-6. Epub 2025 Oct 14.

  • Ahrens K, Blackburn N, Aalsma M, Haggerty K, Kelleher K, Knight DK, Joseph E, Mulford C, Ryle T, Tolou-Shams M. Prevention of Opioid Use and Disorder Among Youth Involved in the Legal System: Innovation and Implementation of Four Studies Funded by the NIDA HEAL Initiative. Prev Sci. 2023 Oct;24(Suppl 1):99-110. doi: 10.1007/s11121-023-01566-6. Epub 2023 Jul 1.

  • Chavez L, Kelleher K, Bunger A, Brackenoff B, Famelia R, Ford J, Feng X, Mallory A, Martin J, Sheftall A, Walsh L, Yilmazer T, Slesnick N. Housing First Combined with Suicide Treatment Education and Prevention (HOME + STEP): study protocol for a randomized controlled trial. BMC Public Health. 2021 Jun 12;21(1):1128. doi: 10.1186/s12889-021-11133-9.

  • Slesnick N, Chavez L, Bunger A, Famelia R, Ford J, Feng X, Higgins S, Holowacz E, Jaderlund S, Luthy E, Mallory A, Martin J, Walsh L, Yilmazer T, Kelleher K. Housing, opportunities, motivation and engagement (HOME) for homeless youth at-risk for opioid use disorder: study protocol for a randomized controlled trial. Addict Sci Clin Pract. 2021 May 12;16(1):30. doi: 10.1186/s13722-021-00237-7.

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Housing

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private FacilitiesResidence CharacteristicsDemographyPopulation CharacteristicsEnvironment, ControlledEnvironmentEnvironment and Public HealthEpidemiologic MeasurementsPublic Health

Results Point of Contact

Title
Natasha Slesnick
Organization
The Oho State University

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2019

First Posted

October 23, 2019

Study Start

June 23, 2020

Primary Completion

May 14, 2024

Study Completion

May 14, 2024

Last Updated

September 15, 2025

Results First Posted

September 15, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations