Methamphetamine Use Disorder Support in Heart Failure Pilot Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Southern California

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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

    Other intervention

    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

    Other intervention

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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Multidisciplinary HF clinic integrating MUD managementOther 2 interventions

Trial outcomes

Primary outcomes

1

Abstinence from Methamphetamine

The rate of abstinence from meth will be defined as the percentage of negative urine toxicology results/number of visits. A total of 36 visits/person to the Heart Failure clinic over the 6 months of follow-up will be scheduled.

Time frame
From enrollment to the end of intervention at 6 months
2

GDMT optimization - drug class prescribing

Guideline-directed medical therapies (GDMT) optimization will be evaluated by percentage prescribed all 4 GDMT drug classes

Time frame
From enrollment to the end of intervention at 6 months
3

GDMT optimization - dosing

Guideline-directed medical therapies (GDMT) optimization will be evaluated by percentage of patients on GDMT target doses and half-target doses.

Time frame
From enrollment to the end of intervention at 6 months

Secondary outcomes

1

BSCS score changes over time

A Brief Substance Craving Scale (BSCS) is a 4-item Likert-scale patient-reported tool that measures frequency and intensity of cravings. Scores range from 0-12, with higher scores indicating greater craving. Survey will be conducted at last visit of each month in a total of 6 months.

Time frame
From enrollment to the end of intervention at 6 months
2

KCCQ-12 score changes over time

A 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated tool and performance measure for quality of care, assessing patient symptoms, functional limitations, and quality of life in patients with HF. Scores range from 0-100, with higher scores indicating better health status. Survey will be conducted at last visit of each month in a total of 6 months.

Time frame
From enrollment to the end of intervention at 6 months

Other outcomes

1

Health care costs

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.

Time frame
From enrollment to the end of intervention at 6 months

Sponsors and contacts

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University of Southern California

Lead sponsor

Los Angeles General Medical Center

Collaborator

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