Beginning Early and Assertive Treatment for Methamphetamine Use Disorder (BEATMeth)

Beginning Early and Assertive Treatment for Methamphetamine Use Disorder (BEATMeth): A Comprehensive Systems-level Secondary Prevention Strategy to Prevent Stimulant Related Overdoses

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.

Study Overview

• Status: Completed
• Conditions: Methamphetamine Use Disorder
• Intervention / Treatment: Behavioral: care navigation

Detailed Description

To date, a public health systems approach to enhance linkage and engagement in care for stimulant use disorders is lacking. This shortcoming arises in part from the lack of effective treatments for stimulant use disorders (StUD), the specific pathology of methamphetamine use, and gaps in epidemiologic knowledge related to methamphetamine use disorder. Unlike opioid use disorders, for which medications relieve dysphoric symptoms of acute withdrawal and prevent relapse, patients with StUD present to care with methamphetamine-induced psychosis and may be combative, agitated, and poorly insightful to their need for treatment. In response to community demands, our team at Denver Health recently established a pilot program, Beginning Early and Assertive Treatment for Methamphetamine Use Disorder (BEAT Meth), to protocolize the assessment and treatment of patients with methamphetamine-induced psychosis.The current research project aims to develop and conduct process and outcomes evaluations of a linkage intervention aimed at increasing continuation and engagement in treatment for stimulant use disorder.

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80204
      • Denver Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Dedicated care navigator to address social support needs	Behavioral: care navigation; Dedicated care navigation throughout study enrollment and follow-up period. Care navigation consists of addressing social support needs (e.g. transportation, communication, housing).
No Intervention: Usual care; Standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants retained in treatment at 30 days	Retention in treatment at 30 days	30 days
Number of participants who overdosed	non-fatal overdose as self-reported and fatal overdose from medical examiner	through study completion, an average of 1 year
Number of participants retained in treatment at 90 days	Retention in treatment at 90 days	90 days

Collaborators and Investigators

• Sponsor: Denver Health and Hospital Authority
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Alia A Al-Tayyib, PhD, Denver Health

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2023
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): September 29, 2025

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: September 11, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Estimated): November 13, 2025
• Last Update Submitted That Met QC Criteria: November 11, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 22-0968; R01CE003363 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No