Methamphetamine Use Disorder Support in Heart Failure Pilot Study

NCT ID: NCT07211724

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2026-07-31

Brief Summary

Heart failure (HF) affects over 6 million people in the US and is a major cause of both hospital admissions and death. HF has many causes and contributing factors. One of the most aggressive forms of HF is associated with methamphetamine abuse, which has become its own epidemic in the US over the past twenty years. People who use methamphetamine tend to develop HF at a much younger age, with more severe disease and more serious consequences. A recent analysis using nationwide data, methamphetamine use doubled the risk of death or hospitalizations compared to non-users in patients with HF. Thus, methamphetamine users with HF represent a very high-risk group of patients from a healthcare perspective.

HF may be reversible in some patients who use methamphetamine if patients can achieve 1) abstain from further methamphetamine use and 2) consistently take all the medications that can improve HF. These two goals are very difficult to achieve in practice, as the care of both methamphetamine addiction and HF requires specialized medical expertise and intensive regular follow up of patients. In general, achievement of one goal is not possible without the other. Patients who use methamphetamine have poor adherence to medical follow-up and therapies, and abstinence from methamphetamine is difficult to maintain. This is further complicated because the current model of HF care does not incorporate treatment for methamphetamine use.

The current study proposes to launch a multidisciplinary clinic that treats both HF and methamphetamine use disorder at the same time. The HF care will be led by a cardiologist while the methamphetamine use treatment will be led by a psychiatric clinical pharmacist trained in addiction medicine. State-of-the-art HF care will include optimization of four pillar HF medications. Methamphetamine use treatment will include counseling and incentivized abstinence known as contingency management (CM). The investigators will manage the patients in the clinic for 6 months total.

The investigators are interested in demonstrating that this integrated clinic model will result in improved delivery of care for these patients by reporting the rates of successful abstinence from methamphetamine, improved optimization of the four HF medications, and enhanced patient reported quality of life over the 6 months of follow up. The investigators will also collect data on the costs associated with providing this level of care and estimate a range of potential cost-savings.

Detailed Description

Prospective, open-label, single-arm study to evaluate the feasibility and preliminary efficacy of a multidisciplinary HF clinic which integrates MUD management along with standard-of-care guideline directed HF management. The MUD treatment plan will be pragmatic, consisting of behavioral counseling, CM with or without pharmacotherapy (see below). Patients with HF and concomitant active meth use will be enrolled consecutively and managed in the clinic for 6 months. The pragmatic approach to MUD treatment will allow for individualization of therapy plans reflecting current MUD guidelines. The overarching objective of the current proposal is to demonstrate the feasibility and preliminary value of a HF clinic for meth users that integrates MUD treatment. The central hypothesis is that incorporation of simultaneous meth use abstinence incentives and aid with HF management in a singular clinic visit model will improve care delivery metrics associated with improved HF outcomes. The hypothesis aligns with HF guidelines that emphasize the essential role of incorporating comorbidity management into routine care of patients with HF.

Specific Aim 1 will define the rate of successful abstinence from meth with implementation of a multidisciplinary meth HF clinic utilizing contingency +/- pharmacologic management strategies alongside standard HF care in a prospective, open-label pragmatic study. Patients with HF and documented meth use will be consecutively enrolled for follow-up in the study clinic. Along with standard-of-care management of HF, patients will work with the addiction medicine pharmacist to receive an individualized MUD treatment plan for 6 months. Implementation of an effective MUD treatment plan will result in both improved abstinence from meth, as well as adherence to clinic visits and HF therapies over the 6 months of follow-up, establishing the feasibility and model for this multidisciplinary integrated clinic.

Specific Aim 2 will assess the clinical value of the meth HF clinic to improve HF care quality metrics. As a pilot study, patient adherence to HF GDMT and follow-up appointments will be descriptively quantified, along with achievement of GDMT target doses at 1, 3, and 6 months. Changes in patient quality of life from baseline will be ascertained utilizing the Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Since MUD represents an established barrier to patient adherence with medical therapies, the integration of MUD with HF care will improve these HF care quality metrics associated with improved patient outcomes in HF. These data will demonstrate the preliminary value for this multidisciplinary integrated clinic.

Specific Aim 3 will enumerate the healthcare resources and costs required for implementation, and further attempt to estimate the range of cost savings associated with the meth HF clinic. To demonstrate feasibility and replicability, the costs associated with this care model will be estimated through prospective collection of care delivery data across all study patients, including personnel time and other direct costs of the MUD treatment. Cost savings will be estimated based on projected reductions in health resource use (e.g., reduced out- and inpatient encounters). The cost and savings components will be the foundation for designing both a payer-perspective budget impact analysis, and a societal-perspective full cost-effectiveness analysis for incorporation into a future randomized, controlled study of the clinical and economic impacts of the clinic.

The study will establish the feasibility and preliminary value of an innovative model of care delivery for very high-risk patients with HF and MUD that reduces barriers to optimizing the care and benefit. The broader impact will be established by demonstrating that increased meth abstinence improves adherence and GDMT optimization, underscoring the value of systems that provide a holistic patient-centric approach to HF management. Specifically, the achievement of many of the guideline-recommended HF clinical performance and quality measures can be enhanced by incorporating SUD treatment into the standard of care for HF.

Conditions

Heart Failure; Methamphetamine Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Multidisciplinary HF clinic integrating MUD management

This is a single-arm study to evaluate the feasibility and preliminary efficacy of a multidisciplinary HF clinic which integrates MUD management along with standard-of-care guideline directed HF management.

Group Type: OTHER

MUD Management (contingency management +/- adjunctive MUD pharmacotherapy)

Intervention Type: OTHER

Management of MUD will be individualized for each study patient. All patients will receive behavioral counseling utilizing motivational interviewing and education and offered a contingency management (CM) plan incentivizing abstinence from meth. Several pharmacotherapies are recommended for the treatment of MUD: mirtazapine, bupropion and naltrexone, or bupropion monotherapy. If required, adjunctive MUD pharmacotherapy will be added to the CM guided by comorbid conditions, patient characteristics, and characteristics of use.

HF GDMT management

Intervention Type: OTHER

As per standard clinical care, patients will be followed by a cardiologist for HF management including assessment for GDMT optimization.

Interventions

MUD Management (contingency management +/- adjunctive MUD pharmacotherapy)

Management of MUD will be individualized for each study patient. All patients will receive behavioral counseling utilizing motivational interviewing and education and offered a contingency management (CM) plan incentivizing abstinence from meth. Several pharmacotherapies are recommended for the treatment of MUD: mirtazapine, bupropion and naltrexone, or bupropion monotherapy. If required, adjunctive MUD pharmacotherapy will be added to the CM guided by comorbid conditions, patient characteristics, and characteristics of use.

Intervention Type: OTHER

HF GDMT management

As per standard clinical care, patients will be followed by a cardiologist for HF management including assessment for GDMT optimization.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Heart failure diagnosis meeting universal definition criteria with left ventricular ejection fraction ≤ 40%
• Active methamphetamine use and stated desire to cease (confirmed by patient self-reported history of active use and /or positive urine toxicology obtained as part of routine patient care); physician verifying patients meets criteria for MUD.
• Age 18 years or older
• Empaneled to LA General Medical Center/DHS
• Able to provide informed consent (translated consent forms will be used for non-English speakers)

Exclusion Criteria

• Polysubstance use (excluding tobacco and marijuana)
• Documented history of alcohol use disorder (DSM-5) or alcohol dependence (ICD-11). Intermittent alcohol use below these thresholds (e.g. social use) is not an exclusion.
• Cardiogenic shock requiring mechanical circulatory support at time of presentation
• Acute coronary syndrome, acute pulmonary embolism, or hemodynamically significant arrhythmia on admission
• Pregnancy
• Acute psychiatric condition requiring immediate treatment or significantly impairing their ability to provide informed consent or participate in study procedures

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Los Angeles General Medical Center

OTHER

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Tien Ng

Professor of Clinical Pharmacy and Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tien Ng, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California, Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences

Locations

Los Angeles General Medical Center

Los Angeles, California, United States

University of Southern California, Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences

Los Angeles, California, United States

Countries

United States

Central Contacts

Tien Ng, PharmD

Role: CONTACT

tienng@usc.edu

323-442-1840

David Dadiomov, PharmD

Role: CONTACT

dadiomov@usc.edu

323-442-1414

Facility Contacts

Maxine W Stachel, MD

Role: primary

Maxine.Stachel@med.usc.edu

213-240-8443

Tien Ng, PharmD

Role: primary

tienng@usc.edu

323-442-1840

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Related Links

https://www.samhsa.gov/data/sites/default/files/cbhsq-reports/NSDUHNationalFindingsReport2018/NSDUHNationalFindingsReport2018.pdf

Center for Behavioral Health Statistics and Quality SAaMHSA. Substance Abuse and Mental Health Services Administration. Key Substance Use and Mental Health Indicators in the United States: Results from the 2018 National Survey on Drug Use and Health.

Other Identifiers

HS-25-00064

Identifier Type: -

Identifier Source: org_study_id