Rehabilitation Program for People With Methamphetamine-Associated Cardiopulmonary Conditions (INSPIRE)

October 28, 2026 updated by: Michael Incze

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Behavioral: 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
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
Other: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Baseline, 1, 3, and 6 months
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)
Baseline, 1, 3, and 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of Life - Short Form 20
Time Frame: Baseline, 1, 3, and 6 months

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.
Baseline, 1, 3, and 6 months
Quality of Life - Kansas City Cardiomyopathy Questionnaire-12
Time Frame: Baseline, 1, 3, and 6 months

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.
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

Measure of self-efficacy to avoid substance use with the Drug Avoidance Self-Efficacy Scale (DASES).
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

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.
Baseline, 1, 3, and 6 months
Contingency Management App Engagement
Time Frame: 3 months and 6 months

Number of weekly App Log-Ins, Contingency Management Draws and Earnings
3 months and 6 months
Hospital Readmissions in the Past 30 Days
Time Frame: Baseline, 1, 3, and 6 months

Self-Reported Hospital admissions in the past 30 days using Timeline Follow Back
Baseline, 1, 3, and 6 months
Emergency Department Visits in the Past 30 days
Time Frame: Baseline, 1, 3, and 6 months

Self-Reported number of ED visits in the past 30 days using Timeline Follow Back
Baseline, 1, 3, and 6 months
Urgent Care Visits in the Past 30 Days
Time Frame: Baseline, 1, 3, and 6 months

Self-Reported number of urgent care visits in the past 30 days using Timeline Follow Back
Baseline, 1, 3, and 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
INSPIRE Acceptability assessed via 4-item Intervention Acceptability Measure (IAM)
Time Frame: immediately after the intervention (12 weeks from randomization)

Measure of INSPIRE acceptability through the IAM survey collected one time from all patient participants one time at the end of the intervention
immediately after the intervention (12 weeks from randomization)
INSPIRE Appropriateness assessed via 4-item Appropriateness of Intervention Measure (AIM)
Time Frame: immediately after the intervention (12 weeks from randomization)

Measure of INSPIRE appropriateness through Appropriateness of Intervention Measure (AIM) collected one time from all patient participants one time at the end of the intervention
immediately after the intervention (12 weeks from randomization)
Reach of the Intervention Over the Entire Study Period
Time Frame: Measured starting from the first randomization and ending after the final participant is randomized (up to 100 weeks after first randomization)

Number of different counties and states represented by enrolled participants measured from the first randomization to the final randomization.
Measured starting from the first randomization and ending after the final participant is randomized (up to 100 weeks after first randomization)
Sustainment of intervention
Time Frame: Measured between 12 weeks (end of intervention) and 24 weeks after randomization

Number of intervention participants who continue to log into the contingency management/peer support app in the three months after the intervention ends as assessed through app utilization data
Measured between 12 weeks (end of intervention) and 24 weeks after randomization
Feasibility
Time Frame: Measured starting from the first randomization and ending after the final participant has completed the intervention, discontinued the study, or was lost to follow-up (up to 112 weeks after first randomization)

Average number of enrollments per month and percentage of enrolled participants who complete the intervention
Measured starting from the first randomization and ending after the final participant has completed the intervention, discontinued the study, or was lost to follow-up (up to 112 weeks after first randomization)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Michael Incze

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
University of Utah

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael A Incze, MD, University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 13, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB_00204022
  • 1R21DA066520-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be available within 12 months of study conclusion

IPD Sharing Access Criteria

Data will be archived in The Hive. The Hive is a publicly-accessible repository for research data generated by UHealth researchers, students, and staff. It is maintained by the Marriott Library IT and Digital Collections. The Hive has policies and procedures in place that will provide data access to qualified researchers, fully consistent with NIH data-sharing policies and applicable laws and regulations. Deidentified data within The Hive will be shared with other investigators who propose specific aims/hypotheses in order to identify the data elements required and who receive agreement from the appropriate project leaders.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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