Methamphetamine Use DisorderBEATMethNCT06033365
Beginning Early and Assertive Treatment for Methamphetamine Use Disorder
A study testing care navigation in people with Methamphetamine Use Disorder, run by Denver Health and Hospital Authority at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Methamphetamine Use Disorder
- What is being tested?
- care navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2023to 29 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- identified in the Denver Health healthcare system who have had a methamphetamine-related encounter at Denver Health
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Methamphetamine Use Disorder
- Being tested
- care navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
care navigationBehavioural
Dedicated care navigation throughout study enrollment and follow-up period. Care navigation consists of addressing social support needs (e.g. transportation, communication, housing).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Dedicated care navigator to address social support needs Receives: Behavioral: care navigation |
| Usual care | No intervention | Standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 30 of study enrollment
Secondary outcomes (3)
Number of participants retained in treatment at 30 days
Retention in treatment at 30 days
Measured: 30 days
Number of participants who overdosed
non-fatal overdose as self-reported and fatal overdose from medical examiner
Measured: through study completion, an average of 1 year
Number of participants retained in treatment at 90 days
Retention in treatment at 90 days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start11 Apr 2023
- Primary completion31 Dec 2024
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Methamphetamine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Alia A Al-Tayyib, PhD, Principal investigator, Denver Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033365
- Sponsor's protocol ID
- 22-0968
- Other IDs
- R01CE003363
- Acronym
- BEATMeth
- Status last verified
- Nov 2025
- First submitted
- 25 Apr 2023
- Last updated
- 13 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Tayyib A, Rinehart DJ, Duarte KG, Gilbert A, Newton C, Loh R, Bacon E, Simpson SA. Care Navigation for Methamphetamine Use Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2026 Sep 1;9(9):e2631628. doi: 10.1001/jamanetworkopen.2026.31628.
PubMed 42684700
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beginning Early and Assertive Treatment for Methamphetamine Use Disorder (BEATMeth): A Comprehensive Systems-level Secondary Prevention Strategy to Prevent Stimulant Related Overdoses
- ClinicalTrials.gov ID
- NCT06033365
- Acronym / sponsor ID
- BEATMeth / 22-0968
- Conditions
- Methamphetamine Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: care navigationDedicated care navigator to address social support needs |
| Usual care | No intervention | –Standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age and older
- identified in the Denver Health healthcare system who have had a methamphetamine-related encounter at Denver Health
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| care navigationDedicated care navigation throughout study enrollment and follow-up period. Care navigation consists of addressing social support needs (e.g. transportation, communication, housing). | Behavioural | Intervention |
Primary outcome
Number of participants who entered treatment for methamphetamine use disorder
Time frame: within 30 of study enrollment
Treatment entry as defined as attendance at an outpatient addiction treatment appointment within 30 days of BEAT Meth discharge
3 secondary outcomes
Number of participants retained in treatment at 30 days
Time frame: 30 days
Number of participants who overdosed
Time frame: through study completion, an average of 1 year
Number of participants retained in treatment at 90 days
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Derived from this study: PubMed 42684700Al-Tayyib A, Rinehart DJ, Duarte KG, Gilbert A, Newton C, Loh R, Bacon E, Simpson SA. Care Navigation for Methamphetamine Use Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2026 Sep 1;9(9):e2631628. doi: 10.1001/jamanetworkopen.2026.31628.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alia A Al-Tayyib, PhD principal investigator
Denver Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing care navigation in people with Methamphetamine Use Disorder, run by Denver Health and Hospital Authority at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who entered treatment for methamphetamine use disorder (time frame: within 30 of study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06033365, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.