Cocaine Use DisorderRCT (04)NCT03224546
Cocaine Use Reduction and Health
A study testing Contingency Management in people with Cocaine Use Disorder, run by William Stoops at 1 site in United States.
Trial summary
Reduced drug use is a clinically meaningful target for treatment development, but few studies have evaluated the positive impacts produced by this behavioral change, preventing adoption of this endpoint in clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cocaine Use Disorder
- What is being tested?
- Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2017to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Self-report of recent cocaine use verified by a cocaine-positive urine sample
- Meet moderate-severe Cocaine Use Disorder Criteria
- Seeking treatment for their cocaine use
- Able to commit to 12-week intervention, plus 24-week follow up
Who cannot join
- History of serious physical or psychiatric disease (e.g., physical dependence on any drug requiring medically managed detoxification, unstable angina, uncontrolled cardiac arrhythmia, aortic stenosis, self-reported compromised immune function, extreme hypersensitivity/allergy to candida yeast or similar products, severe diagnosis for other substance use disorder) that would interfere with study participation
- Current physical or psychiatric disease that would interfere with study participation
- Poor veinous access, precluding blood draws
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular, Immune and Psychosocial Benefits of Reduced Cocaine Use
Reduced drug use is a clinically meaningful target for treatment development, but few studies have evaluated the positive impacts produced by this behavioral change, preventing adoption of this endpoint in clinical trials. The proposed research will fill that critical knowledge gap by demonstrating the biopsychosocial benefits of reduced cocaine use. These data will be used to change current accepted cocaine treatment endpoints and accelerate identification of therapies for cocaine use disorder.
- Conditions
- Cocaine Use Disorder
- Being tested
- Contingency Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency ManagementBehavioural
Subjects will receive payments for providing cocaine negative urine samples.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | This group will receive payment for providing urine samples throughout the trial. |
| Low Value Alternative Reinforcer Group | Experimental | This group will receive payment for providing cocaine negative urine samples throughout the trial. Receives: Behavioral: Contingency Management |
| High Value Alternative Reinforcer Group | Experimental | This group will receive payment for providing cocaine negative urine samples throughout the trial. Receives: Behavioral: Contingency Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelin-1 Levels
Endothelin-1 levels will be measured. They will be recorded in pg/ml.
Measured: At baseline.
Endothelin-1 Levels
Endothelin-1 levels will be measured. They will be recorded in pg/ml.
Measured: Week 6 of study participation
Endothelin-1 Levels
Endothelin-1 levels will be measured. They will be recorded in pg/ml.
Measured: Week 12 of study participation
Mean Arterial Pressure
Mean Arterial Pressure is recorded during participant visits and is recorded in mm Hg
Measured: At baseline
Mean Arterial Pressure
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Measured: Week 1 of participation
Mean Arterial Pressure
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Measured: Week 2 of participation
Mean Arterial Pressure
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Measured: Week 3 of participation
Mean Arterial Pressure
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Measured: Week 4 of participation
Mean Arterial Pressure
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Measured: Week 5 of participation
Mean Arterial Pressure
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Measured: Week 6 of participation
Mean Arterial Pressure
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Measured: Week 7 of participation
Mean Arterial Pressure
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Measured: Week 8 of participation
Mean Arterial Pressure
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Measured: Week 9 of participation
Mean Arterial Pressure
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Measured: Week 10 of participation
Mean Arterial Pressure
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Measured: Week 11 of participation
Mean Arterial Pressure
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Measured: Week 12 of participation
Secondary outcomes (33)
Interleukin-10
Interleukin-10 levels will be measured throughout subject participation. They will be recorded in pg/ml.
Measured: At baseline.
Interleukin-10
Interleukin-10 levels will be measured throughout subject participation. They will be recorded in pg/ml.
Measured: Week 6 of study participation
Interleukin-10
Interleukin-10 levels will be measured throughout subject participation. They will be recorded in pg/ml.
Measured: Week 12 of study participation
Total Sleep Time
Sleep time the night before in minutes
Measured: At baseline
Total Sleep Time
Sleep time the night before in minutes
Measured: Week 1 of participation
Total Sleep Time
Sleep time the night before in minutes
Measured: Week 2 of participation
Total Sleep Time
Sleep time the night before in minutes
Measured: Week 3 of participation
Total Sleep Time
Sleep time the night before in minutes
Measured: Week 4 of participation
Total Sleep Time
Sleep time the night before in minutes
Measured: Week 5 of participation
Total Sleep Time
Sleep time the night before in minutes
Measured: Week 6 of participation
Total Sleep Time
Sleep time the night before in minutes
Measured: Week 7 of participation
Total Sleep Time
Sleep time the night before in minutes
Measured: Week 8 of participation
Total Sleep Time
Sleep time the night before in minutes
Measured: Week 9 of participation
Total Sleep Time
Sleep time the night before in minutes
Measured: Week 10 of participation
Total Sleep Time
Sleep time the night before in minutes
Measured: Week 11 of participation
Total Sleep Time
Sleep time the night before in minutes
Measured: Week 12 of participation
Hamilton Depression Scale Score
Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Measured: At baseline
Hamilton Depression Scale Score
Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Measured: Week 1 of Participation
Hamilton Depression Scale Score
Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Measured: Week 2 of Participation
Hamilton Depression Scale Score
Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Measured: Week 3 of Participation
Hamilton Depression Scale Score
Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Measured: Week 4 of Participation
Hamilton Depression Scale Score
Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Measured: Week 5 of Participation
Hamilton Depression Scale Score
Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Measured: Week 6 of Participation
Hamilton Depression Scale Score
Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Measured: Week 7 of Participation
Hamilton Depression Scale Score
Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Measured: Week 8 of Participation
Hamilton Depression Scale Score
Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Measured: Week 9 of Participation
Hamilton Depression Scale Score
Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Measured: Week 10 of Participation
Hamilton Depression Scale Score
Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Measured: Week 11 of Participation
Hamilton Depression Scale Score
Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Measured: Week 12 of Participation
Criteria for Cocaine Use Disorder Diagnosis
Number of criteria met on a Structured Clinical Interview as endorsed yes/no on a series of 11 questions on a scale. Range = 0-11. Higher scores indicate greater severity of Cocaine Use Disorder (e.g., more life problems due to cocaine use).
Measured: At Baseline
Criteria for Cocaine Use Disorder Diagnosis
Number of criteria met on a Structured Clinical Interview as endorsed yes/no on a series of 11 questions on a scale. Range = 0-11. Higher scores indicate greater severity of Cocaine Use Disorder (e.g., more life problems due to cocaine use).
Measured: Week 12 of Participation
Reactive Hyperemia Index
Measure of peripheral arterial tonomotry which assesses peripheral microvascular function through changes in amplitude of pulses in fingertips. Reactive hyperemia index (RHI) is "determined by calculating the ratio of hyperemic pressure (RHm) to baseline pressure (BLm) in the measurement and control arms (RHc and BLc respectively)" (Rosenberry and Nelson, 2020). This yields a natural log RHI ratio with higher scores indicating worse microvascular function. Being calculated as a natural log, there range is infinite.
Measured: At Baseline
Reactive Hyperemia Index
Measure of peripheral arterial tonomotry which assesses peripheral microvascular function through changes in amplitude of pulses in fingertips. Reactive hyperemia index (RHI) is "determined by calculating the ratio of hyperemic pressure (RHm) to baseline pressure (BLm) in the measurement and control arms (RHc and BLc respectively)" (Rosenberry and Nelson, 2020). This yields a natural log RHI ratio with higher scores indicating worse microvascular function. This yields a natural log RHI ratio with higher scores indicating worse microvascular function. Being calculated as a natural log, there range is infinite.
Measured: Week 12 of participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start15 Sep 2017
- Primary completion15 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cocaine Use DisorderStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Stoops
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, William Stoops, University of Kentucky
- Investigators
- William W Stoops, Ph.D., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224546
- Sponsor's protocol ID
- Randomized Clinical Trial (04)
- Other IDs
- R01DA043938
- Acronym
- RCT (04)
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2017
- Last updated
- 1 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A formal plan for sharing final research data is not required for investigator-initiated applications with direct costs of less than $500,000. However, we felt it important to verify that the results (i.e., summary statistics and graphical/tabular representation of the data) from this study will be presented at local, regional, national and/or international conferences. In addition, a manuscript or manuscripts describing the results will be prepared for submission to a peer-reviewed journal or journals, and the final, accepted version(s) of the manuscript(s) will be submitted to PubMed Central. As requested, the final research data will be made available to oversight or regulatory committees. The rights and privacy of individuals who participated will be protected at all times, and at no time will identifiers be included that would permit linkages to the individual subjects and variables that could lead to deductive disclosure of the identity of subjects.
Publications
Ferretti ML, Regnier SD, Irons JG, Stoops WW. Polysubstance use patterns and risk behaviors among people with cocaine use disorder. Exp Clin Psychopharmacol. 2025 Dec;33(6):586-593. doi: 10.1037/pha0000813.
PubMed 41343351Stoops WW, Shellenberg TP, Regnier SD, Cox DH, Adatorwovor R, Hays LR, Anderson DM, Lile JA, Schmitz JM, Havens JR, Segerstrom SC. Influence of cocaine use reduction on markers of immune function. J Neuroimmunol. 2024 Dec 15;397:578470. doi: 10.1016/j.jneuroim.2024.578470. Epub 2024 Oct 28.
PubMed 39504756Regnier SD, Shellenberg TP, Koffarnus MN, Cox DH, Lile JA, Rush CR, Stoops WW. Cocaine abstinence during the "critical period" of a contingency management trial predicts future abstinence in people with cocaine use disorder. Drug Alcohol Depend. 2023 Dec 1;253:111030. doi: 10.1016/j.drugalcdep.2023.111030. Epub 2023 Nov 18.
PubMed 38006674
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular, Immune and Psychosocial Benefits of Reduced Cocaine Use
- ClinicalTrials.gov ID
- NCT03224546
- Acronym / sponsor ID
- RCT (04) / Randomized Clinical Trial (04)
- Conditions
- Cocaine Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- William StoopsUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Posted 1 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Reduced drug use is a clinically meaningful target for treatment development, but few studies have evaluated the positive impacts produced by this behavioral change, preventing adoption of this endpoint in clinical trials. The proposed research will fill that critical knowledge gap by demonstrating the biopsychosocial benefits of reduced cocaine use. These data will be used to change current accepted cocaine treatment endpoints and accelerate identification of therapies for cocaine use disorder.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –This group will receive payment for providing urine samples throughout the trial. |
| Low Value Alternative Reinforcer Group | Experimental | Behavioral: Contingency ManagementThis group will receive payment for providing cocaine negative urine samples throughout the trial. |
| High Value Alternative Reinforcer Group | Experimental | Behavioral: Contingency ManagementThis group will receive payment for providing cocaine negative urine samples throughout the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or older
- Self-report of recent cocaine use verified by a cocaine-positive urine sample
- Meet moderate-severe Cocaine Use Disorder Criteria
- Seeking treatment for their cocaine use
- Able to commit to 12-week intervention, plus 24-week follow up
Key exclusion criteria (3 listed)
- History of serious physical or psychiatric disease (e.g., physical dependence on any drug requiring medically managed detoxification, unstable angina, uncontrolled cardiac arrhythmia, aortic stenosis, self-reported compromised immune function, extreme hypersensitivity/allergy to candida yeast or similar products, severe diagnosis for other substance use disorder) that would interfere with study participation
- Current physical or psychiatric disease that would interfere with study participation
- Poor veinous access, precluding blood draws
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 |
|---|---|---|
| Contingency ManagementSubjects will receive payments for providing cocaine negative urine samples. | Behavioural | High Value Alternative Reinforcer Group, Low Value Alternative Reinforcer Group |
Primary outcome
Endothelin-1 Levels
Time frame: At baseline.
Endothelin-1 levels will be measured. They will be recorded in pg/ml.
Endothelin-1 Levels
Time frame: Week 6 of study participation
Endothelin-1 levels will be measured. They will be recorded in pg/ml.
Endothelin-1 Levels
Time frame: Week 12 of study participation
Endothelin-1 levels will be measured. They will be recorded in pg/ml.
Mean Arterial Pressure
Time frame: At baseline
Mean Arterial Pressure is recorded during participant visits and is recorded in mm Hg
Mean Arterial Pressure
Time frame: Week 1 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
Time frame: Week 2 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
Time frame: Week 3 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
Time frame: Week 4 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
Time frame: Week 5 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
Time frame: Week 6 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
Time frame: Week 7 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
Time frame: Week 8 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
Time frame: Week 9 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
Time frame: Week 10 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
Time frame: Week 11 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
Time frame: Week 12 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
33 secondary outcomes
Interleukin-10
Time frame: At baseline.
Interleukin-10
Time frame: Week 6 of study participation
Interleukin-10
Time frame: Week 12 of study participation
Total Sleep Time
Time frame: At baseline
Total Sleep Time
Time frame: Week 1 of participation
Total Sleep Time
Time frame: Week 2 of participation
Total Sleep Time
Time frame: Week 3 of participation
Total Sleep Time
Time frame: Week 4 of participation
Total Sleep Time
Time frame: Week 5 of participation
Total Sleep Time
Time frame: Week 6 of participation
Total Sleep Time
Time frame: Week 7 of participation
Total Sleep Time
Time frame: Week 8 of participation
Total Sleep Time
Time frame: Week 9 of participation
Total Sleep Time
Time frame: Week 10 of participation
Total Sleep Time
Time frame: Week 11 of participation
Total Sleep Time
Time frame: Week 12 of participation
Hamilton Depression Scale Score
Time frame: At baseline
Hamilton Depression Scale Score
Time frame: Week 1 of Participation
Hamilton Depression Scale Score
Time frame: Week 2 of Participation
Hamilton Depression Scale Score
Time frame: Week 3 of Participation
Hamilton Depression Scale Score
Time frame: Week 4 of Participation
Hamilton Depression Scale Score
Time frame: Week 5 of Participation
Hamilton Depression Scale Score
Time frame: Week 6 of Participation
Hamilton Depression Scale Score
Time frame: Week 7 of Participation
Hamilton Depression Scale Score
Time frame: Week 8 of Participation
Hamilton Depression Scale Score
Time frame: Week 9 of Participation
Hamilton Depression Scale Score
Time frame: Week 10 of Participation
Hamilton Depression Scale Score
Time frame: Week 11 of Participation
Hamilton Depression Scale Score
Time frame: Week 12 of Participation
Criteria for Cocaine Use Disorder Diagnosis
Time frame: At Baseline
Criteria for Cocaine Use Disorder Diagnosis
Time frame: Week 12 of Participation
Reactive Hyperemia Index
Time frame: At Baseline
Reactive Hyperemia Index
Time frame: Week 12 of participation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41343351Ferretti ML, Regnier SD, Irons JG, Stoops WW. Polysubstance use patterns and risk behaviors among people with cocaine use disorder. Exp Clin Psychopharmacol. 2025 Dec;33(6):586-593. doi: 10.1037/pha0000813.
- Derived from this study: PubMed 39504756Stoops WW, Shellenberg TP, Regnier SD, Cox DH, Adatorwovor R, Hays LR, Anderson DM, Lile JA, Schmitz JM, Havens JR, Segerstrom SC. Influence of cocaine use reduction on markers of immune function. J Neuroimmunol. 2024 Dec 15;397:578470. doi: 10.1016/j.jneuroim.2024.578470. Epub 2024 Oct 28.
- Derived from this study: PubMed 38006674Regnier SD, Shellenberg TP, Koffarnus MN, Cox DH, Lile JA, Rush CR, Stoops WW. Cocaine abstinence during the "critical period" of a contingency management trial predicts future abstinence in people with cocaine use disorder. Drug Alcohol Depend. 2023 Dec 1;253:111030. doi: 10.1016/j.drugalcdep.2023.111030. Epub 2023 Nov 18.
- Individual participant dataSharing planned: No. A formal plan for sharing final research data is not required for investigator-initiated applications with direct costs of less than $500,000. However, we felt it important to verify that the results (i.e., summary statistics and graphical/tabular representation of the data) from this study will be presented at local, regional, national and/or international conferences. In addition, a manuscript or manuscripts describing the results will be prepared for submission to a peer-reviewed journal or journals, and the final, accepted version(s) of the manuscript(s) will be submitted to PubMed Central. As requested, the final research data will be made available to oversight or regulatory committees. The rights and privacy of individuals who participated will be protected at all times, and at no time will identifiers be included that would permit linkages to the individual subjects and variables that could lead to deductive disclosure of the identity of subjects.
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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. This study is not recruiting at the moment.
William W Stoops, Ph.D. principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management in people with Cocaine Use Disorder, run by William Stoops 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 1 Aug 2024. 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?
Yes. Results are posted in the registry (first posted 1 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelin-1 Levels (time frame: At baseline.). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03224546, which also lists 3 linked publications.
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 1 Aug 2024.