Supportive Management for Heart Failure and Methamphetamine Addiction

(Meth-HF Trial)

Not yet recruiting at 1 trial location

Overseen By David Dadiomov, PharmD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Polysubstance use, Alcohol use disorder, others

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

Compensation: Varies

Number of Visits: 36

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new clinical approach for individuals with heart failure (HF) who also struggle with methamphetamine use. It aims to improve health by combining heart care led by a heart specialist with addiction support (Methamphetamine Use Disorder Support) led by an addiction expert. The main goal is to help participants stop using methamphetamine, improve heart medication adherence, and enhance their quality of life over six months. Suitable candidates for this trial have heart failure, a history of methamphetamine use, and a desire to quit. As an unphased trial, this study offers a unique opportunity to explore a novel approach to improving both heart health and addiction recovery.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it focuses on optimizing heart failure medications, so you may need to adjust your treatment under the guidance of the trial's medical team.

What prior data suggests that this integrated clinic model is safe for patients with heart failure and methamphetamine use disorder?

Research has shown that treating heart failure (HF) in individuals who use methamphetamine is complicated because the drug exacerbates the condition. Methamphetamine use can double the risk of death or hospitalization for those with HF. However, addressing both HF treatment and methamphetamine addiction can lead to better health outcomes.

Specific safety data for this combined treatment approach is not yet available. The trial is in an early stage, so limited safety information exists. The plan includes standard HF care and counseling for methamphetamine use, both generally safe in other contexts. This approach could improve care without adding significant safety risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it integrates methamphetamine use disorder (MUD) management directly into a heart failure (HF) clinic setting. Unlike the standard approach, which treats heart failure and methamphetamine addiction separately, this method offers a combined care model. By addressing both conditions simultaneously, it hopes to improve patient outcomes more effectively than treating each condition in isolation. This multidisciplinary approach is promising because it can provide comprehensive care tailored to the patient's unique needs, potentially leading to better adherence and health improvements.

What evidence suggests that this integrated clinic model is effective for heart failure and methamphetamine use disorder?

Research has shown that heart problems caused by methamphetamine use are very serious and can lead to more hospital visits and higher death rates. Studies indicate that stopping meth use can help improve heart problems in some people if they also take their heart medications regularly. In this trial, participants will attend a multidisciplinary heart failure clinic where both heart issues and methamphetamine use are addressed together. Early findings suggest that combining heart care with support for meth addiction, such as counseling and rewards for staying drug-free, can improve patients' heart health and quality of life. This combined care aims to make it easier for patients to follow their treatments and avoid meth, potentially leading to better health outcomes. ^{2 3 6 7 8}

Who Is on the Research Team?

Tien Ng, PharmD

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for individuals with heart failure (HF) who also struggle with methamphetamine addiction. It aims to help patients abstain from drug use and manage their HF by taking all necessary medications regularly.

Inclusion Criteria

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

Empaneled to LA General Medical Center/DHS

Able to provide informed consent (translated consent forms will be used for non-English speakers)

Exclusion Criteria

Cardiogenic shock requiring mechanical circulatory support at time of presentation

Pregnancy

Polysubstance use (excluding tobacco and marijuana)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive integrated care for heart failure and methamphetamine use disorder, including counseling and incentivized abstinence, over 6 months

6 months

36 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Methamphetamine Use Disorder Support

Trial Overview

The study tests a new clinic model that treats both HF and methamphetamine use disorder simultaneously, using a combination of cardiology-led HF care and psychiatric pharmacist-led addiction treatment over six months.

How Is the Trial Designed?

Group I: Multidisciplinary HF clinic integrating MUD management Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Los Angeles General Medical Center

Collaborator

Trials

1

Recruited

70+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07211724

Methamphetamine Use Disorder Support in Heart Failure ...

... HF clinic for meth users that integrates MUD treatment. The central ... Methamphetamine Use Disorder Support in Heart Failure (Meth HF) Pilot Study.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11312028/

Facing a Tsunami: Methamphetamine Heart Failure ...

In regard to cardiovascular disease, hospitalizations for methamphetamine cardiomyopathy with associated HF (MethHF) in California increased by ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0147956324002309

Methamphetamine-associated heart failure: Clinical ...

Methamphetamine use is increasing and is associated with development of heart failure (HF). However, clinical characteristics and outcomes have not been well- ...

4.

ahajournals.org

ahajournals.org/doi/10.1161/JAHA.120.016704

Clinical Characteristics and Management of ...

Methamphetamine use and heart failure: prevalence, risk factors, and predictors. Am J Emerg Med. 2018;36:1423–1428. Go to Citation. Crossref.

5.

jacc.org

jacc.org/doi/10.1016/j.jacadv.2024.100840

Cardiomyopathy-Associated Hospital Admissions Among ...

Characteristics and outcomes of methamphetamine abuse among veterans with heart failure. Am J Cardiol. 2019;124:6: 907-911. Go to Citation.

6.

ahajournals.org

ahajournals.org/doi/10.1161/JAHA.120.018370

Methamphetamine‐Associated Heart Failure ...

Total nationwide MethHF hospitalizations increased from 547 in 2002 to 6625 in 2014 with a predominance on the West Coast. Methamphetamine abuse ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9513700/

Methamphetamine causes cardiovascular dysfunction via ...

Recent studies have revealed increased prevalence of cardiovascular disease (CVD) due to METH use, making cardiovascular complications the second leading cause ...

8.

medrxiv.org

medrxiv.org/content/10.1101/2024.04.22.24306200v1.full-text

Methamphetamine-associated Heart Failure: Clinical ...

This study aimed to compare clinical characteristics and outcomes among individuals with HF who do and do not use methamphetamines in a safety-net hospital.