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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06033365
Other study ID # 22-0968
Secondary ID R01CE003363
Status Recruiting
Phase N/A
First received
Last updated
Start date April 11, 2023
Est. completion date September 2025

Study information

Verified date March 2023
Source Denver Health and Hospital Authority
Contact Alia A Al-Tayyib, PhD
Phone 3036023601
Email alia.al-tayyib@dhha.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 182
Est. completion date September 2025
Est. primary completion date September 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
United States Denver Health Denver Colorado

Sponsors (2)

Lead Sponsor Collaborator
Denver Health and Hospital Authority Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Number of participants retained in treatment at 30 days Retention in treatment at 30 days 30 days
Secondary 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
Secondary Number of participants retained in treatment at 90 days Retention in treatment at 90 days 90 days
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