NCT06033365

Brief Summary

The overall goal of the study is to evaluate the effectiveness of a secondary prevention strategy implemented at a systems-level to prevent stimulant related overdoses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration 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

Study Start

First participant enrolled

April 11, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2025

Completed
Last Updated

November 13, 2025

Status Verified

November 1, 2025

Enrollment Period

1.7 years

First QC Date

April 25, 2023

Last Update Submit

November 11, 2025

Conditions

Methamphetamine Use Disorder

Outcome Measures

Primary Outcomes (1)

  • Number of participants who entered treatment for methamphetamine use disorder

    Treatment entry as defined as attendance at an outpatient addiction treatment appointment within 30 days of BEAT Meth discharge

    within 30 of study enrollment

Secondary Outcomes (3)

  • Number of participants retained in treatment at 30 days

    30 days

  • Number of participants who overdosed

    through study completion, an average of 1 year

  • Number of participants retained in treatment at 90 days

    90 days

Study Arms (2)

Intervention

EXPERIMENTAL

Dedicated care navigator to address social support needs

Behavioral: care navigation

Usual care

NO INTERVENTION

Standard of care.

Interventions

care navigationBEHAVIORAL

Dedicated care navigation throughout study enrollment and follow-up period. Care navigation consists of addressing social support needs (e.g. transportation, communication, housing).

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age and older
  • identified in the Denver Health healthcare system who have had a methamphetamine-related encounter at Denver Health

You may not qualify if:

  • unable to complete the interview in English
  • intoxicated or impaired and unable to consent to participate in the project and/or respond to the interview
  • currently under residential involuntary psychiatric or substance treatment order (i.e., mental health hold, emergency commitment, or short-term certification)
  • received any type of substance use treatment at DHHA in the last 90 days
  • planning to enter substance treatment
  • unable to complete the research visits in the next 90 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denver Health

Denver, Colorado, 80204, United States

Location

Study Officials

  • Alia A Al-Tayyib, PhD

    Denver Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2023

First Posted

September 13, 2023

Study Start

April 11, 2023

Primary Completion

December 31, 2024

Study Completion

September 29, 2025

Last Updated

November 13, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)