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Beginning Early and Assertive Treatment for Methamphetamine Use Disorder

NCT ID: NCT06033365

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-11

Study Completion Date

2025-09-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Methamphetamine Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention

Dedicated care navigator to address social support needs

Group Type EXPERIMENTAL

care navigation

Intervention Type BEHAVIORAL

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

Usual care

Standard of care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Denver Health and Hospital Authority

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alia A Al-Tayyib, PhD

Role: PRINCIPAL_INVESTIGATOR

Denver Health

Locations

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Denver Health

Denver, Colorado, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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R01CE003363

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-0968

Identifier Type: -

Identifier Source: org_study_id