NCT07211724Toborzás még nem indult
Methamphetamine Use Disorder Support in Heart Failure Pilot Study
Methamphetamine Use Disorder Support in Heart Failure (Meth HF) Pilot Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 4.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 50 (tervezett)
- Első benyújtás
- 2025. szept. 23.
- Kezdés
- 2026. máj. 31.
- Elsődleges befejezés
- 2027. máj. 31.
- Fő szponzor
- University of Southern California
- Betegségek
- Szívelégtelenség
- NCT-szám
- NCT07211724
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 50
- 2026. máj. 31. és az elsődleges befejezés (2027. máj. 31.) között
- 2 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Más betegség
- 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.
- Acute coronary syndrome, acute pulmonary embolism, or hemodynamically significant arrhythmia on admission
- Acute psychiatric condition requiring immediate treatment or significantly impairing their ability to provide informed consent or participate in study procedures
Egyéb
- Polysubstance use (excluding tobacco and marijuana)
- Cardiogenic shock requiring mechanical circulatory support at time of presentation
- Pregnancy
Kiket keres a vizsgálat
- 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)
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (2)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Los Angeles General Medical Center | Los Angeles | Egyesült Államok | Ismeretlen állapot |
| University of Southern California, Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences | Los Angeles | Egyesült Államok | Ismeretlen állapot |
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