Recruiting

INSPIRE

Sponsor:

Michael Incze

Code:

NCT07915882

Conditions

Methamphetamine-Associated Heart Failure

Methamphetamine-Associated Pulmonary Arterial Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Increasing control over stimulant use and physical health through incentivized rehabilitation

Usual Care

Study Details

Brief summary:

The purpose of this study is to evaluate the feasibility and preliminary effectiveness of increasing control over stimulant use and physical health through incentivized rehabilitation (INSPIRE). INSPIRE is a 12-week remotely-delivered collaborative care intervention for rural patients with Methamphetamine-Associated Heart Failure (Me-HF) or Methamphetamine-Associated Pulmonary Arterial Hypertension (Me-PAH) featuring smartphone-based contingency management incentivizing participation in remote synchronous rehabilitation.

Conditions

Methamphetamine-Associated Heart Failure

Methamphetamine-Associated Pulmonary Arterial Hypertension

Study ID

NCT07915882

Start date

Oct 13, 2026

Status verified date

Oct, 2026

Completion date

Oct 31, 2028

Anticipated

Primary completion date

Oct 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Active methamphetamine use determined by positive urine drug testing within the past 3 months and/or self-reported current use
  • Current diagnosis of chronic heart failure or pulmonary hypertension documented in the electronic health record
  • Possession of a smartphone
  • Able to participate in virtual exercise rehabilitation

Exclusion Criteria:

  • Currently incarcerated
  • Unable to interact with smartphone app and/or virtual health coaching sessions in English
  • Unstable arrhythmia, defined as any known arrhythmia that is associated with hemodynamic effects like syncope, hypotension, or decompensated heart failure
  • Decompensated chronic heart failure or pulmonary hypertension
  • NYHA class IV symptoms
  • Myocardial infarction within the past 3 months, percutaneous coronary intervention within the past 2 weeks, coronary artery bypass graft within the past 3 months, or implantable cardiac defibrillator/cardiac resynchronization therapy/pacemaker implantation within the last 6 weeks
  • Unstable angina, uncontrolled hypertension, acute myocarditis/pericarditis, intracardiac thrombus
  • Severe symptomatic aortic stenosis

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: INSPIRE

Participants randomized to INSPIRE will receive usual medical care plus a 12-week program featuring collaborative care and app-based contingency management incentivizing participation in remotely-delivered synchronous exercise rehabilitation sessions

active comparator: Usual Care

Participants randomized to Usual Care will receive standard of care services routinely available at the University of Utah, including specialty cardiology, pulmonology and addiction care and in-person cardiac and pulmonary rehabilitation services

Interventions

Increasing control over stimulant use and physical health through incentivized rehabilitation

Standard medical care plus a 12-week program featuring collaborative care and app-based contingency management incentivizing participation in remotely-delivered synchronous exercise rehabilitation sessions

Usual Care

Standard care services routinely available at the University of Utah Health, including specialty cardiology, pulmonology and addiction care and in-person cardiac and pulmonary rehabilitation services

Primary outcome measure

  • Change in metabolic equivalents (METs) [ Time Frame: Baseline, 1, 3, and 6 months ]
  • Change in self-reported substance use [ Time Frame: Baseline, 1, 3, and 6 months ]

Central Contacts and Locations

Central contacts

Michael A Incze, MD

801-581-2000Michael.Incze@hsc.utah.edu

Locations

University of Utah Health

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Michael A Incze, MD

801-581-2000Michael.Incze@hsc.utah.edu

Dominique Ingram

801-581-2000dominique.ingram@utah.edu

More Information

Sponsor

Michael Incze

Last update posted

Nov 4, 2026

Last verified

Oct, 2026

Keywords

  • Methamphetamine
  • Stimulant Use Disorder
  • Collaborative Care
  • Contingency Management
  • Substance Use Disorders
  • Cardiac Rehabilitation
  • Telehealth
  • Mobile App

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-05. This information was provided to ClinicalTrials.gov by Michael Incze on 2026-11-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.