An interventional study of Increasing control over stimulant use and physical health through incentivized rehabilitation and Usual Care in Methamphetamine-Associated Heart Failure and Methamphetamine-Associated Pulmonary Arterial Hypertension, sponsored by Michael Incze. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Michael Incze · Not applicable, Interventional, and Treatment
Among 1,589 studies in Substance-Related Disorders with a site in United States — 250 open to participants now, 314 under way, 4 of them phase 3. Substance-Related Disorders · United States.
Among the 1,589 studies in Substance-Related Disorders with a site in United States, this one is the 1,043rd largest by planned enrollment of the 1,447 interventional ones that give a count, is one of 94 that started in 2026, is one of 958 with no phase, reaches primary completion later than 225 of the 313 other live ones, and was the 1,583rd registered.
2,241 studies on the registry are indexed under Substance-Related Disorders; 410 are open to participants now.
Browse Substance-Related Disorders studies →250 of the 1,589 studies in Substance-Related Disorders with a site in United States are open now. Recruiting first, the newest first:
Emory University · Sites in United States
Ages 18+ · Healthy volunteers
National Institute on Drug Abuse (NIDA) · Sites in United States
Ages 18–120
National Institute on Drug Abuse (NIDA) · Sites in United States
Ages 18–65 · Healthy volunteers
University of Massachusetts, Worcester · Sites in United States
Ages 18+
University of Texas Southwestern Medical Center · Sites in United States
Ages 18–65
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 265 Substance-Related Disorders studies recruiting now, 130 (49%) set no upper age limit and 117 (44%) stop at 75 or younger; 55 take children under 18; 89 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,589 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 172 · Phase 2 242 · Phase 3 79 · Phase 4 67
First in 1990; this study’s year is marked. 94 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 45 is below the median of 108 across 1,843 interventional studies indexed under Substance-Related Disorders.
Median enrollment 104 across the 1,447 interventional studies, 234 across the 137 observational. Of the 1,173 that completed or were terminated, 376 (32%) have results posted.
This tab as a report to print or save as PDF → With an account.
83 of 1,589 have an industry lead sponsor. The 10 most frequent:
Michael Incze is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Michael Incze has 2 studies filed under Substance-Related Disorders — fewer than ten, so there is no comparison to draw.
100 of the studies in Substance-Related Disorders with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07566273Cornell UniversityMicropractices for Unhoused LGBTQ Youth | 2026-11 |
| NCT05835921Indiana UniversityEnhancing Prospective Thinking in Early Recovery | 2026-11-15 |
| NCT05897164Evidence-Based Practice Institute, Seattle, WAMobile Technology to Reduce Teen Substance Misuse | 2026-11-30 |
| NCT04317482University of ArkansasThe Human Stress Response in a Simulated ED Setting | 2026-12 |
| NCT05713695University of Massachusetts, WorcesterSupporting Treatment Access and Recovery Through Linkage and Support | 2026-12 |
Add all 100 to your calendar (.ics) → With an account.
Among the 1,589 studies in Substance-Related Disorders with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 medical care plus a 12-week program featuring collaborative care and app-based contingency management incentivizing participation in remotely-delivered synchronous exercise rehabilitation sessions
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
Change in metabolic equivalents (METs)
Change in METs before and after the intervention measured via Duke Activity Status Indicator (DASI)
Time frame: 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)
Time frame: Baseline, 1, 3, and 6 months
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.
Time frame: 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.
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.
Measure of self-efficacy to avoid substance use with the Drug Avoidance Self-Efficacy Scale (DASES).
Time frame: 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.
Time frame: Baseline, 1, 3, and 6 months
Contingency Management App Engagement
Number of weekly App Log-Ins, Contingency Management Draws and Earnings
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 1, 3, and 6 months
INSPIRE Acceptability assessed via 4-item Intervention Acceptability Measure (IAM)
Measure of INSPIRE acceptability through the IAM survey collected one time from all patient participants one time at the end of the intervention
Time frame: immediately after the intervention (12 weeks from randomization)
INSPIRE Appropriateness assessed via 4-item Appropriateness of Intervention Measure (AIM)
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
Time frame: immediately after the intervention (12 weeks from randomization)
Reach of the Intervention Over the Entire Study Period
Number of different counties and states represented by enrolled participants measured from the first randomization to the final randomization.
Time frame: Measured starting from the first randomization and ending after the final participant is randomized (up to 100 weeks after first randomization)
Sustainment of intervention
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
Time frame: Measured between 12 weeks (end of intervention) and 24 weeks after randomization
Feasibility
Average number of enrollments per month and percentage of enrolled participants who complete the intervention
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)
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will be available within 12 months of study conclusion
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.
Data sharing details ↗ · hive.utah.edu
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Oct 2028, 24 months after the start.
Of 814 non-industry interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's planned 24 months is below that.
Counting every sponsor, half of 854 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Michael Incze