Methamphetamine-Associated Heart FailureINSPIRENCT07915882
Rehabilitation Program for People With Methamphetamine-Associated Cardiopulmonary Conditions
A study of Methamphetamine-Associated Heart Failure and Methamphetamine-Associated Pulmonary Arterial Hypertension, run by Michael Incze at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Methamphetamine-Associated Heart Failure, Methamphetamine-Associated Pulmonary Arterial Hypertension
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2026to 31 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Utah Health
Salt Lake City, Utah, 84108
Michael A Incze, MD, 801-581-2000, Michael.Incze@hsc.utah.edu
Dominique Ingram, 801-581-2000, dominique.ingram@utah.edu
About this study
Official title: Feasibility of a Remote Collaborative Care-Facilitated Contingency Management-Exercise Rehabilitation Program for People With Methamphetamine-Associated Cardiopulmonary Conditions
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
- Being tested
- Increasing control over stimulant use and physical health through incentivized rehabilitation, Usual Care
- Keywords
- Methamphetamine, Stimulant Use Disorder, Collaborative Care, Contingency Management, Substance Use Disorders, Cardiac Rehabilitation, Telehealth, Mobile App
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increasing control over stimulant use and physical health through incentivized rehabilitationBehavioural
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 CareOther
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
| Study group | Role | What they receive |
|---|---|---|
| INSPIRE | Experimental | 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 Receives: Behavioral: Increasing control over stimulant use and physical health through incentivized rehabilitation |
| Usual Care | Active comparator | 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 Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in metabolic equivalents (METs)
Change in METs before and after the intervention measured via Duke Activity Status Indicator (DASI)
Measured: Baseline, 1, 3, and 6 months
Change in self-reported substance use
Change in self-reported substance use amount and frequency via Timeline Follow Back (TLFB)
Measured: Baseline, 1, 3, and 6 months
Secondary outcomes (8)
Quality of Life - Short Form 20
Measure of participants' quality of life using the Short Form 20 (SF-20) questionnaire. The score range of this survey is 0-100, with higher scores indicating better overall quality of life.
Measured: Baseline, 1, 3, and 6 months
Quality of Life - Kansas City Cardiomyopathy Questionnaire-12
Measure of participant's quality of life using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12). The score range of this survey is 0-100, with higher scores indicating better functioning and less limitation from heart failure symptoms.
Measured: Baseline, 1, 3, and 6 months
Self-Efficacy Related to Avoiding Substance Use with the Drug Avoidance Self-Efficacy Scale (DASES). The score range of this survey is 0-96, with higher scores indicating better self-efficacy to avoid substance use.
Measure of self-efficacy to avoid substance use with the Drug Avoidance Self-Efficacy Scale (DASES).
Measured: Baseline, 1, 3, and 6 months
Recovery Capital using the Brief Assessment of Recovery Capital (BARC-10) questionnaire
Measure of the internal and external resources (recovery capital) that help initiate and sustain recovery from substance use disorder, using the Brief Assessment of Recovery Capital (BARC-10) questionnaire. The score range of this survey is 10-60, with higher scores indicating a greater amount of recovery capital.
Measured: Baseline, 1, 3, and 6 months
Contingency Management App Engagement
Number of weekly App Log-Ins, Contingency Management Draws and Earnings
Measured: 3 months and 6 months
Hospital Readmissions in the Past 30 Days
Self-Reported Hospital admissions in the past 30 days using Timeline Follow Back
Measured: Baseline, 1, 3, and 6 months
Emergency Department Visits in the Past 30 days
Self-Reported number of ED visits in the past 30 days using Timeline Follow Back
Measured: Baseline, 1, 3, and 6 months
Urgent Care Visits in the Past 30 Days
Self-Reported number of urgent care visits in the past 30 days using Timeline Follow Back
Measured: Baseline, 1, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start13 Oct 2026
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine-Associated Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Incze
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Utah
- Responsible party
- Sponsor-investigator, Michael Incze, University of Utah
- Investigators
- Michael A Incze, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915882
- Sponsor's protocol ID
- IRB_00204022
- Other IDs
- 1R21DA066520-01
- Acronym
- INSPIRE
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual de-identified responses to the following surveys will be preserved and shared: 1) SF-20, 2) Kansas City Cardiomyopathy Questionnaire-12, 3) DASI, 4) TLFB data, 5) Drug Avoidance Self-Efficacy Scale, 6) BARC-10, 7) Appropriateness of Intervention Measure, 8) Intervention Acceptability Measure, and 9) App engagement and CM earnings data, 10) Self-reported data on substance use and acute care utilization, 11) demographic and substance use history enrollment surveys. De-identified biometric data and qualitative interview transcripts will also be preserved and shared. All data will be stored within a secure computing environment. All participant identifiers (e.g., names and addresses) will be removed and maintained in a secure file for future contact purposes. Participant identifiers will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Remote Collaborative Care-Facilitated Contingency Management-Exercise Rehabilitation Program for People With Methamphetamine-Associated Cardiopulmonary Conditions
- ClinicalTrials.gov ID
- NCT07915882
- Acronym / sponsor ID
- INSPIRE / IRB_00204022
- Conditions
- Methamphetamine-Associated Heart Failure, Methamphetamine-Associated Pulmonary Arterial Hypertension
- Keywords
- Methamphetamine, Stimulant Use Disorder, Collaborative Care, Contingency Management, Substance Use Disorders, Cardiac Rehabilitation, Telehealth, Mobile App
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Michael InczeUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Utah
- Study start
- 13 Oct 2026 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INSPIRE | Experimental | Behavioral: Increasing control over stimulant use and physical health through incentivized rehabilitationParticipants 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 |
| Usual Care | Active comparator | Other: Usual CareParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Increasing control over stimulant use and physical health through incentivized rehabilitationStandard medical care plus a 12-week program featuring collaborative care and app-based contingency management incentivizing participation in remotely-delivered synchronous exercise rehabilitation sessions | Behavioural | INSPIRE |
| Usual CareStandard 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 | Other | Usual Care |
Primary outcome
Change in metabolic equivalents (METs)
Time frame: Baseline, 1, 3, and 6 months
Change in METs before and after the intervention measured via Duke Activity Status Indicator (DASI)
Change in self-reported substance use
Time frame: Baseline, 1, 3, and 6 months
Change in self-reported substance use amount and frequency via Timeline Follow Back (TLFB)
8 secondary outcomes
Quality of Life - Short Form 20
Time frame: Baseline, 1, 3, and 6 months
Quality of Life - Kansas City Cardiomyopathy Questionnaire-12
Time frame: Baseline, 1, 3, and 6 months
Self-Efficacy Related to Avoiding Substance Use with the Drug Avoidance Self-Efficacy Scale (DASES). The score range of this survey is 0-96, with higher scores indicating better self-efficacy to avoid substance use.
Time frame: Baseline, 1, 3, and 6 months
Recovery Capital using the Brief Assessment of Recovery Capital (BARC-10) questionnaire
Time frame: Baseline, 1, 3, and 6 months
Contingency Management App Engagement
Time frame: 3 months and 6 months
Hospital Readmissions in the Past 30 Days
Time frame: Baseline, 1, 3, and 6 months
Emergency Department Visits in the Past 30 days
Time frame: Baseline, 1, 3, and 6 months
Urgent Care Visits in the Past 30 Days
Time frame: Baseline, 1, 3, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes. Individual de-identified responses to the following surveys will be preserved and shared: 1) SF-20, 2) Kansas City Cardiomyopathy Questionnaire-12, 3) DASI, 4) TLFB data, 5) Drug Avoidance Self-Efficacy Scale, 6) BARC-10, 7) Appropriateness of Intervention Measure, 8) Intervention Acceptability Measure, and 9) App engagement and CM earnings data, 10) Self-reported data on substance use and acute care utilization, 11) demographic and substance use history enrollment surveys. De-identified biometric data and qualitative interview transcripts will also be preserved and shared. All data will be stored within a secure computing environment. All participant identifiers (e.g., names and addresses) will be removed and maintained in a secure file for future contact purposes. Participant identifiers will not be shared.
Related trials for Methamphetamine-Associated Heart Failure
Recruiting
Rural Community Peer Partnerships for Improving Methamphetamine-Associated Heart Failure Screening and Engagement
Methamphetamine Use, Heart Failure
Not yet recruiting
Methamphetamine Use Disorder Support in Heart Failure Pilot Study
Heart Failure, Methamphetamine Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael A Incze, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Methamphetamine-Associated Heart Failure and Methamphetamine-Associated Pulmonary Arterial Hypertension, run by Michael Incze at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael A Incze, MD (801-581-2000, Michael.Incze@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in metabolic equivalents (METs) (time frame: Baseline, 1, 3, and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.