Care Navigation for Methamphetamine Addiction

(BEATMeth Trial)

Overseen By Deborah Rinehart, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Denver Health and Hospital Authority

Disqualifiers: Non-English, Intoxicated, Psychiatric hold, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to support individuals with methamphetamine-related issues. The researchers aim to determine if a dedicated care navigator, who manages social support needs, can prevent overdoses more effectively than standard care. Participants will receive either standard care or additional support from a care navigator. Individuals who have had a methamphetamine-related visit at Denver Health and can speak English may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative care strategies that could significantly enhance support for those facing methamphetamine-related challenges.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that Care Navigation is safe for preventing stimulant related overdoses?

Research has shown that care navigation is generally safe for individuals dealing with methamphetamine addiction. This method organizes support to improve health outcomes. Studies have found that social support can enhance health management.

Care navigation does not involve medications or medical procedures, resulting in a low risk of physical side effects. It guides individuals to the right resources and support systems for recovery. Consequently, there are no reports of harmful physical effects, making it a well-tolerated option for those needing support.

Participants in care navigation often find it helpful in managing their addiction and related health issues. By focusing on social and community support, it is considered a safe and supportive approach for those struggling with methamphetamine use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Care Navigation approach for methamphetamine addiction because it introduces a dedicated care navigator to specifically address social support needs, which is not typically part of the standard treatment. Unlike traditional methods that often rely solely on counseling and medication, this approach provides personalized support to help individuals navigate the social and environmental challenges of addiction recovery. By focusing on the broader social context of recovery, the Care Navigation method has the potential to improve outcomes and offer a more holistic solution for those struggling with methamphetamine addiction.

What evidence suggests that Care Navigation is effective for methamphetamine addiction?

Studies have shown that assisting individuals with substance use problems, such as methamphetamine addiction, can improve health outcomes. In this trial, some participants will receive care navigation, where a dedicated person helps patients find resources and support. Research indicates that this method can reduce drug use and enhance overall well-being. Care navigation ensures patients receive necessary support, which is crucial for recovery. By simplifying access to services and providing personalized help, care navigation has shown promise in aiding those struggling with methamphetamine addiction. ^{1 3 6 7 8}

Who Is on the Research Team?

Alia A Al-Tayyib, PhD

Principal Investigator

Denver Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had a meth-related health issue at Denver Health and haven't received substance use treatment there in the last 90 days. It's not for those planning to enter substance treatment soon, unable to interview in English, impaired, or under involuntary psychiatric/substance treatment orders.

Inclusion Criteria

You have had a methamphetamine-related incident while being enrolled in the Denver Health healthcare system.

Exclusion Criteria

I cannot complete an interview in English.

I am able to understand and consent to participate in the study.

planning to enter substance treatment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a dedicated care navigator to address social support needs as part of the intervention

4 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for retention in treatment and overdose occurrences

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Care Navigation

Trial Overview The study tests how well a new system-level strategy works to prevent overdoses related to stimulant use by providing care navigation services as an early intervention method.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Dedicated care navigator to address social support needs

Group II: Usual care Active Control 1 Intervention

Standard of care.

Who Is Running the Clinical Trial?

Denver Health and Hospital Authority

Lead Sponsor

Trials

106

Recruited

403,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

Published Research Related to This Trial

Integrating behavioral health staff into primary care teams is crucial for effectively coordinating substance use disorder (SUD) services, as it helps facilitate important transitions in patient care.

The study identified operational practices from community health centers that successfully coordinate SUD services, but ongoing coordination remains a challenge, highlighting the need for further research to improve health and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing care for patients with substance abuse disorders at community health centers. Gurewich, D., Prottas, J., Sirkin, JT.[2013]

Among 572,582 patients in community health centers, only 3.0% had documented alcohol use disorders (AUDs) and 1.1% had opioid use disorders (OUDs), indicating a significant prevalence of substance use disorders in this population.

Medication-assisted treatments (MAT) for AUDs and OUDs were underprescribed, with only 3.2% of AUD patients and 29.0% of OUD patients receiving MAT, despite MAT being associated with increased screening for HIV and hepatitis C.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication-assisted treatment for substance use disorders within a national community health center research network. Rieckmann, T., Muench, J., McBurnie, MA., et al.[2018]

A study analyzing data from 846 counties across the US found significant disparities in buprenorphine provider availability, with a median of only 5.9 providers per 100,000 residents, despite a median opioid overdose death rate of 20.0 deaths per 100,000 residents.

Regions, particularly in the Southern and Midwestern US, show a concerning mismatch where high overdose death rates coincide with low access to buprenorphine treatment, highlighting a critical need for improved access to this effective medication for opioid addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between buprenorphine provider availability and opioid deaths among US counties. Jones, CW., Christman, Z., Smith, CM., et al.[2019]

A study of 255 regular methamphetamine users in Melbourne over 12 months found that those with riskier use patterns, such as injecting, were more likely to seek professional support for their drug use.

General practitioners were the most frequently accessed source of support, highlighting the importance of healthcare providers in encouraging treatment initiation and addressing associated harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with professional support access among a prospective cohort of methamphetamine users. Quinn, B., Stoové, M., Dietze, P.[2013]

In a study of 298 HIV-negative women who use methamphetamine in San Francisco, 69% reported needing care for chronic health conditions, with 31% having unmet needs for such care in the past six months.

A striking 92% of participants indicated a need for women's preventive healthcare, and 46% had unmet needs in the past year, highlighting significant gaps in healthcare access for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unmet healthcare need among women who use methamphetamine in San Francisco. Powelson, E., Lorvick, J., Lutnick, A., et al.[2021]

A study involving 801 hospitalized patients with HIV and substance use found that patient navigation, with or without financial incentives, did not improve HIV viral suppression rates compared to standard treatment after 12 months.

Despite the structured interventions aimed at enhancing care coordination and motivation, there were no significant differences in treatment success rates among the three groups, indicating that these approaches may not be effective in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Patient Navigation With or Without Financial Incentives on Viral Suppression Among Hospitalized Patients With HIV Infection and Substance Use: A Randomized Clinical Trial. Metsch, LR., Feaster, DJ., Gooden, L., et al.[2022]

Over a 5-year study involving regular methamphetamine users in Melbourne, 56% of participants achieved past-month abstinence, indicating that remission from dependence can be maintained long-term, although 14% relapsed.

Factors such as poor physical health and low social support were linked to ongoing methamphetamine use and dependence, suggesting that addressing these social determinants could be key in treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year Changes in Methamphetamine Use, Dependence, and Remission in a Community-recruited Cohort. Lanyon, C., Nambiar, D., Higgs, P., et al.[2020]

There is a growing need for research into the use of prescription psychostimulants as a treatment for methamphetamine use disorder, as current practices in Canada have not yet integrated these agonist medications, which have been effective for opioid addiction.

The review highlights the importance of understanding the neuropsychiatric complications of chronic methamphetamine use and emphasizes the need for nursing professionals to be equipped with knowledge on assessment, screening, and patient education to better support individuals with this disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescription psychostimulants as a harm reduction and treatment intervention for methamphetamine use disorder and the implications for nursing clinical practice: A scoping review of the literature. Leidl, D., Takhar, P., Li, H.[2023]

Over the study period from 2010 to 2015, there was a modest increase of 5.6 percentage points in counties with access to opioid use disorder (OUD) prescribers, but as of 2015, 60% of US counties still lacked access to buprenorphine prescribers and over 75% lacked access to oral naltrexone prescribers.

Access to OUD treatment was primarily concentrated in urban areas, highlighting significant geographic and potential racial disparities, suggesting a need for targeted educational and training initiatives to improve access in underserved regions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

County-level access to opioid use disorder medications in medicare Part D (2010-2015). Abraham, AJ., Adams, GB., Bradford, AC., et al.[2021]

The study aims to develop a care coordination intervention (CCI) that integrates HIV and substance use disorder (SUD) services using a tablet-based mobile platform, with the goal of improving communication and care for people living with HIV who also have SUD.

Preliminary evaluations will involve 60 treatment providers and assess the CCI's impact on patient retention in dual care, communication quality, and relational coordination over a 6-month period, potentially enhancing treatment efficiency in a fragmented healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile technology intervention to improve care coordination between HIV and substance use treatment providers: development, training, and evaluation protocol. Claborn, K., Becker, S., Ramsey, S., et al.[2018]

Separating addiction care from general medical care leads to poorer quality of medical treatment for patients with substance use issues, highlighting the need for better integration.

Strategies to improve care coordination include engaging patients in general medical settings, managing substance use disorders in primary care, incorporating family perspectives, and developing payment models that support integrated care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Research Agenda to Advance the Coordination of Care for General Medical and Substance Use Disorders. Quinn, AE., Rubinsky, AD., Fernandez, AC., et al.[2018]

Citations

1. withpower.com withpower.com/trial/phase-methamphetamine-use-disorder-3-2023-39db7

Care Navigation for Methamphetamine Addiction ... The available research shows that coordinating care for substance use disorders, like methamphetamine addiction, can lead to better health outcomes. For example ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9762214/

Caring for Patients Using Methamphetamines - PubMed Central This article provides an overview of a collaborative approach to caring for patients using or have used methamphetamine, from the perspective of the primary ...

3. researchgate.net researchgate.net/scientific-contributions/Sydney-Howard-2158442627

Sydney Howard's research works | Massachusetts General ... Sydney Howard's 14 research works with 195 citations, including: Linkage to Care Outcomes Following Treatment in A Low-Threshold Substance Use Disorder ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35841323/

Addressing Methamphetamine Use in Primary Care Primary care providers are using a wide range of tools to screen and treat methamphetamine use, but with little perceived effectiveness.

5. pew.org pew.org/-/media/assets/2020/04/carecoordinationbrief.pdf

Care Coordination Strategies for Patients Can Improve ... Care Coordination Strategies for Patients Can. Improve Substance Use Disorder Outcomes. Models that show promise focus on access to lifesaving medications.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36695412/

Social issues, crisis, and care coordination Overall, participants reported responding to people affected by methamphetamines was complex in nature. Complexity was affected by extensive social ...

7. researchgate.net researchgate.net/publication/361307675_Social_prescribing_A_narrative_review_of_how_community_engagement_can_improve_wellbeing_in_later_life

Social prescribing: A narrative review of how community ... We found that there were five main themes in the outcomes reported: social connection; improvement in the management of health and health status ...

8. bmjopen.bmj.com bmjopen.bmj.com/content/bmjopen/12/4/e054338.full.pdf

Screening and social prescribing in healthcare and ... 3 There is evidence to support screening and social prescribing for social determinants in healthcare, including housing issues, to address ...