Methamphetamine Use Disorder Support in Heart Failure Pilot Study

NCT07211724 | Not Yet Recruiting

• 1 other identifier: HS-25-00064
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure; Methamphetamine Use Disorder

Keywords

Heart Failure; Methamphetamine use disorder; Meth-associated cardiomyopathy; Multidisciplinary

Outcome Measures

Primary Outcomes (3)

• 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.

  From enrollment to the end of intervention at 6 months

• GDMT optimization - drug class prescribing

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

  From enrollment to the end of intervention at 6 months

• GDMT optimization - dosing

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

  From enrollment to the end of intervention at 6 months

Secondary Outcomes (2)

• BSCS score changes over time

  From enrollment to the end of intervention at 6 months

• KCCQ-12 score changes over time

  From enrollment to the end of intervention at 6 months

Other Outcomes (1)

• Health care costs

  From enrollment to the end of intervention at 6 months

Study Arms (1)

Multidisciplinary HF clinic integrating MUD management

OTHER

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.

Other: MUD Management (contingency management +/- adjunctive MUD pharmacotherapy); Other: HF GDMT management

Interventions

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

Multidisciplinary HF clinic integrating MUD management

HF GDMT management OTHER

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

Multidisciplinary HF clinic integrating MUD management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Polysubstance use (excluding tobacco and marijuana)
• 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

Sponsors & Collaborators

• University of Southern California: lead
• Los Angeles General Medical Center: collaborator

Study Sites (2)

Los Angeles General Medical Center

Los Angeles, California, 90089, United States

Location

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

Los Angeles, California, 90089, United States

Location

Related Publications (10)

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  PMID: 33605000 BACKGROUND

• Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.

  PMID: 35363499 BACKGROUND

• Wu JR, Moser DK. Medication Adherence Mediates the Relationship Between Heart Failure Symptoms and Cardiac Event-Free Survival in Patients With Heart Failure. J Cardiovasc Nurs. 2018 Jan/Feb;33(1):40-46. doi: 10.1097/JCN.0000000000000427.

  PMID: 28591004 BACKGROUND

• Gandhi S, Mosleh W, Sharma UC, Demers C, Farkouh ME, Schwalm JD. Multidisciplinary Heart Failure Clinics Are Associated With Lower Heart Failure Hospitalization and Mortality: Systematic Review and Meta-analysis. Can J Cardiol. 2017 Oct;33(10):1237-1244. doi: 10.1016/j.cjca.2017.05.011. Epub 2017 May 24.

  PMID: 28807523 BACKGROUND

• Douglass AR, Maister A, Moeller KE, Salwan A, Vallabh A, Waters K, Payne GH. Exploring the harm reduction paradigm: the role of Board-Certified Psychiatric Pharmacists. Ment Health Clin. 2024 Aug 2;14(4):253-266. doi: 10.9740/mhc.2024.08.253. eCollection 2024 Aug.

  PMID: 39104432 BACKGROUND

• Clinical Guideline Committee (CGC) Members; ASAM Team; AAAP Team; IRETA Team. The ASAM/AAAP Clinical Practice Guideline on the Management of Stimulant Use Disorder. J Addict Med. 2024 May-Jun 01;18(1S Suppl 1):1-56. doi: 10.1097/ADM.0000000000001299.

  PMID: 38669101 BACKGROUND

• Prendergast M, Podus D, Finney J, Greenwell L, Roll J. Contingency management for treatment of substance use disorders: a meta-analysis. Addiction. 2006 Nov;101(11):1546-60. doi: 10.1111/j.1360-0443.2006.01581.x.

  PMID: 17034434 BACKGROUND

• Reddy PKV, Ng TMH, Oh EE, Moady G, Elkayam U. Clinical Characteristics and Management of Methamphetamine-Associated Cardiomyopathy: State-of-the-Art Review. J Am Heart Assoc. 2020 Jun 2;9(11):e016704. doi: 10.1161/JAHA.120.016704. Epub 2020 May 29.

  PMID: 32468897 BACKGROUND

• Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Shay CM, Spartano NL, Stokes A, Tirschwell DL, VanWagner LB, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2020 Update: A Report From the American Heart Association. Circulation. 2020 Mar 3;141(9):e139-e596. doi: 10.1161/CIR.0000000000000757. Epub 2020 Jan 29.

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• Zhao SX, Deluna A, Kelsey K, Wang C, Swaminathan A, Staniec A, Crawford MH. Socioeconomic Burden of Rising Methamphetamine-Associated Heart Failure Hospitalizations in California From 2008 to 2018. Circ Cardiovasc Qual Outcomes. 2021 Jul;14(7):e007638. doi: 10.1161/CIRCOUTCOMES.120.007638. Epub 2021 Jul 13.

  PMID: 34256572 BACKGROUND

Related Links

• 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.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Tien Ng, PharmD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tien Ng, PharmD

CONTACT

323-442-1840; tienng@usc.edu

David Dadiomov, PharmD

CONTACT

323-442-1414; dadiomov@usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Pharmacy and Medicine

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 8, 2025
• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)