BEATMeth: Beginning Early and Assertive Treatment for Methamphetamine Use Disorder

Sponsor
Denver Health and Hospital Authority (Other)
Overall Status
Recruiting
CT.gov ID
NCT06033365
Collaborator
Centers for Disease Control and Prevention (U.S. Fed)
182
1
2
28.7
6.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: care navigation
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
182 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Beginning Early and Assertive Treatment for Methamphetamine Use Disorder (BEATMeth): A Comprehensive Systems-level Secondary Prevention Strategy to Prevent Stimulant Related Overdoses
Actual Study Start Date :
Apr 11, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Number of participants who entered treatment for methamphetamine use disorder [within 30 of study enrollment]

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

Secondary Outcome Measures

  1. Number of participants retained in treatment at 30 days [30 days]

    Retention in treatment at 30 days

  2. Number of participants who overdosed [through study completion, an average of 1 year]

    non-fatal overdose as self-reported and fatal overdose from medical examiner

  3. Number of participants retained in treatment at 90 days [90 days]

    Retention in treatment at 90 days

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Denver Health Denver Colorado United States 80204

Sponsors and Collaborators

  • Denver Health and Hospital Authority
  • Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Alia A Al-Tayyib, PhD, Denver Health

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT06033365
Other Study ID Numbers:
  • 22-0968
  • R01CE003363
First Posted:
Sep 13, 2023
Last Update Posted:
Sep 13, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 13, 2023