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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA043938 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| High Value Alternative Reinforcer Group | Experimental | This group will receive payment for providing cocaine negative urine samples throughout the trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contingency Management | Behavioral | Subjects will receive payments for providing cocaine negative urine samples. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endothelin-1 Levels | Endothelin-1 levels will be measured. They will be recorded in pg/ml. | At baseline. |
| Endothelin-1 Levels | Endothelin-1 levels will be measured. They will be recorded in pg/ml. | Week 6 of study participation |
| Endothelin-1 Levels | Endothelin-1 levels will be measured. They will be recorded in pg/ml. | Week 12 of study participation |
| Mean Arterial Pressure | Mean Arterial Pressure is recorded during participant visits and is recorded in mm Hg | At baseline |
| Mean Arterial Pressure | Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg | Week 1 of participation |
| Mean Arterial Pressure | Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg | Week 2 of participation |
| Mean Arterial Pressure | Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg | Week 3 of participation |
| Mean Arterial Pressure | Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg |
| Measure | Description | Time Frame |
|---|---|---|
| Interleukin-10 | Interleukin-10 levels will be measured throughout subject participation. They will be recorded in pg/ml. | At baseline. |
| Interleukin-10 | Interleukin-10 levels will be measured throughout subject participation. They will be recorded in pg/ml. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William W Stoops, Ph.D. | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41343351 | Derived | 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. | |
| 39504756 | Derived | Stoops 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. |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | This group will receive payment for providing urine samples throughout the trial. |
| FG001 | Low Value Alternative Reinforcer Group | This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples. |
| FG002 | High Value Alternative Reinforcer Group | This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | This group will receive payment for providing urine samples throughout the trial. |
| BG001 | Low Value Alternative Reinforcer Group | This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Endothelin-1 Levels | Endothelin-1 levels will be measured. They will be recorded in pg/ml. | Posted | Mean | Standard Deviation | pg/ml | At baseline. |
|
12 week clinical trial participation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | This group will receive payment for providing urine samples throughout the trial. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal ECG | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William W. Stoops | University of Kentucky | 859-257-5383 | william.stoops@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 9, 2024 | Jun 4, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 9, 2024 | Jan 19, 2024 | ICF_000.pdf |
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| Week 4 of participation |
| Mean Arterial Pressure | Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg | Week 5 of participation |
| Mean Arterial Pressure | Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg | Week 6 of participation |
| Mean Arterial Pressure | Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg | Week 7 of participation |
| Mean Arterial Pressure | Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg | Week 8 of participation |
| Mean Arterial Pressure | Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg | Week 9 of participation |
| Mean Arterial Pressure | Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg | Week 10 of participation |
| Mean Arterial Pressure | Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg | Week 11 of participation |
| Mean Arterial Pressure | Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg | Week 12 of participation |
| Week 6 of study participation |
| Interleukin-10 | Interleukin-10 levels will be measured throughout subject participation. They will be recorded in pg/ml. | Week 12 of study participation |
| Total Sleep Time | Sleep time the night before in minutes | At baseline |
| Total Sleep Time | Sleep time the night before in minutes | Week 1 of participation |
| Total Sleep Time | Sleep time the night before in minutes | Week 2 of participation |
| Total Sleep Time | Sleep time the night before in minutes | Week 3 of participation |
| Total Sleep Time | Sleep time the night before in minutes | Week 4 of participation |
| Total Sleep Time | Sleep time the night before in minutes | Week 5 of participation |
| Total Sleep Time | Sleep time the night before in minutes | Week 6 of participation |
| Total Sleep Time | Sleep time the night before in minutes | Week 7 of participation |
| Total Sleep Time | Sleep time the night before in minutes | Week 8 of participation |
| Total Sleep Time | Sleep time the night before in minutes | Week 9 of participation |
| Total Sleep Time | Sleep time the night before in minutes | Week 10 of participation |
| Total Sleep Time | Sleep time the night before in minutes | Week 11 of participation |
| Total Sleep Time | Sleep time the night before in minutes | Week 12 of participation |
| Hamilton Depression Scale Score | Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56. | At baseline |
| Hamilton Depression Scale Score | Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56. | Week 1 of Participation |
| Hamilton Depression Scale Score | Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56. | Week 2 of Participation |
| Hamilton Depression Scale Score | Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56. | Week 3 of Participation |
| Hamilton Depression Scale Score | Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56. | Week 4 of Participation |
| Hamilton Depression Scale Score | Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56. | Week 5 of Participation |
| Hamilton Depression Scale Score | Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56. | Week 6 of Participation |
| Hamilton Depression Scale Score | Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56. | Week 7 of Participation |
| Hamilton Depression Scale Score | Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56. | Week 8 of Participation |
| Hamilton Depression Scale Score | Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56. | Week 9 of Participation |
| Hamilton Depression Scale Score | Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56. | Week 10 of Participation |
| Hamilton Depression Scale Score | Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56. | Week 11 of Participation |
| Hamilton Depression Scale Score | Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56. | 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). | 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). | 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. | 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. | Week 12 of participation |
| 38006674 | Derived | Regnier 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. |
| BG002 | High Value Alternative Reinforcer Group | This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples. |
|
|
| Primary | Endothelin-1 Levels | Endothelin-1 levels will be measured. They will be recorded in pg/ml. | Available participants to be measured. | Posted | Mean | Standard Deviation | pg/ml | Week 6 of study participation |
|
|
|
| Primary | Endothelin-1 Levels | Endothelin-1 levels will be measured. They will be recorded in pg/ml. | Available participants to be measured. | Posted | Mean | Standard Deviation | pg/ml | Week 12 of study participation |
|
|
|
| Primary | Mean Arterial Pressure | Mean Arterial Pressure is recorded during participant visits and is recorded in mm Hg | Posted | Mean | Standard Deviation | mm Hg | At baseline |
|
|
|
| Primary | Mean Arterial Pressure | Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg | Available participants to be measured. | Posted | Mean | Standard Deviation | mm Hg | Week 1 of participation |
|
|
|
| Primary | Mean Arterial Pressure | Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg | Available participants to be measured. | Posted | Mean | Standard Deviation | mm Hg | Week 2 of participation |
|
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|
| Primary | Mean Arterial Pressure | Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg | Available participants to be measured. | Posted | Mean | Standard Deviation | mm Hg | Week 3 of participation |
|
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| Primary | Mean Arterial Pressure | Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg | Available participants to be measured. | Posted | Mean | Standard Deviation | mm Hg | Week 4 of participation |
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| Primary | Mean Arterial Pressure | Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg | Available participants to be measured. | Posted | Mean | Standard Deviation | mm Hg | Week 5 of participation |
|
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| Primary | Mean Arterial Pressure | Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg | Available participants to be measured. | Posted | Mean | Standard Deviation | mm Hg | Week 6 of participation |
|
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| Primary | Mean Arterial Pressure | Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg | Available participants to be measured. | Posted | Mean | Standard Deviation | mm Hg | Week 7 of participation |
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| Primary | Mean Arterial Pressure | Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg | Available participants to be measured. | Posted | Mean | Standard Deviation | mm Hg | Week 8 of participation |
|
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| Primary | Mean Arterial Pressure | Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg | Available participants to be measured. | Posted | Mean | Standard Deviation | mm Hg | Week 9 of participation |
|
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| Primary | Mean Arterial Pressure | Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg | Available participants to be measured. | Posted | Mean | Standard Deviation | mm Hg | Week 10 of participation |
|
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| Primary | Mean Arterial Pressure | Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg | Available participants to be measured. | Posted | Mean | Standard Deviation | mm Hg | Week 11 of participation |
|
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| Primary | Mean Arterial Pressure | Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg | Available participants to be measured. | Posted | Mean | Standard Deviation | mm Hg | Week 12 of participation |
|
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| Secondary | Interleukin-10 | Interleukin-10 levels will be measured throughout subject participation. They will be recorded in pg/ml. | Posted | Mean | Standard Deviation | pg/ml | At baseline. |
|
|
|
| Secondary | Interleukin-10 | Interleukin-10 levels will be measured throughout subject participation. They will be recorded in pg/ml. | Available participants to be measured. | Posted | Mean | Standard Deviation | pg/ml | Week 6 of study participation |
|
|
|
| Secondary | Interleukin-10 | Interleukin-10 levels will be measured throughout subject participation. They will be recorded in pg/ml. | Available participants to be measured. | Posted | Mean | Standard Deviation | pg/ml | Week 12 of study participation |
|
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| Secondary | Total Sleep Time | Sleep time the night before in minutes | Posted | Mean | Standard Deviation | minutes | At baseline |
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| Secondary | Total Sleep Time | Sleep time the night before in minutes | Available participants to be measured. | Posted | Mean | Standard Deviation | minutes | Week 1 of participation |
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| Secondary | Total Sleep Time | Sleep time the night before in minutes | Available participants to be measured. | Posted | Mean | Standard Deviation | minutes | Week 2 of participation |
|
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| Secondary | Total Sleep Time | Sleep time the night before in minutes | Available participants to be measured. | Posted | Mean | Standard Deviation | minutes | Week 3 of participation |
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| Secondary | Total Sleep Time | Sleep time the night before in minutes | Available participants to be measured. | Posted | Mean | Standard Deviation | minutes | Week 4 of participation |
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| Secondary | Total Sleep Time | Sleep time the night before in minutes | Available participants to be measured. | Posted | Mean | Standard Deviation | minutes | Week 5 of participation |
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| Secondary | Total Sleep Time | Sleep time the night before in minutes | Available participants to be measured. | Posted | Mean | Standard Deviation | minutes | Week 6 of participation |
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| Secondary | Total Sleep Time | Sleep time the night before in minutes | Available participants to be measured. | Posted | Mean | Standard Deviation | minutes | Week 7 of participation |
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| Secondary | Total Sleep Time | Sleep time the night before in minutes | Available participants to be measured. | Posted | Mean | Standard Deviation | minutes | Week 8 of participation |
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| Secondary | Total Sleep Time | Sleep time the night before in minutes | Available participants to be measured. | Posted | Mean | Standard Deviation | minutes | Week 9 of participation |
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| Secondary | Total Sleep Time | Sleep time the night before in minutes | Available participants to be measured. | Posted | Mean | Standard Deviation | minutes | Week 10 of participation |
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| Secondary | Total Sleep Time | Sleep time the night before in minutes | Available participants to be measured. | Posted | Mean | Standard Deviation | minutes | Week 11 of participation |
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| Secondary | Total Sleep Time | Sleep time the night before in minutes | Available participants to be measured. | Posted | Mean | Standard Deviation | minutes | Week 12 of participation |
|
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| Secondary | Hamilton Depression Scale Score | Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56. | Available participants to be measured. | Posted | Median | Inter-Quartile Range | score on a scale | At baseline |
|
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| Secondary | Hamilton Depression Scale Score | Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56. | Available participants to be measured. | Posted | Median | Inter-Quartile Range | score on a scale | Week 1 of Participation |
|
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|
| Secondary | Hamilton Depression Scale Score | Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56. | Available participants to be measured. | Posted | Median | Inter-Quartile Range | score on a scale | Week 2 of Participation |
|
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| Secondary | Hamilton Depression Scale Score | Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56. | Available participants to be measured. | Posted | Median | Inter-Quartile Range | score on a scale | Week 3 of Participation |
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| Secondary | Hamilton Depression Scale Score | Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56. | Available participants to be measured. | Posted | Median | Inter-Quartile Range | score on a scale | Week 4 of Participation |
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| Secondary | Hamilton Depression Scale Score | Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56. | Available participants to be measured. | Posted | Median | Inter-Quartile Range | score on a scale | Week 5 of Participation |
|
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| Secondary | Hamilton Depression Scale Score | Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56. | Available participants to be measured. | Posted | Median | Inter-Quartile Range | score on a scale | Week 6 of Participation |
|
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| Secondary | Hamilton Depression Scale Score | Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56. | Available participants to be measured. | Posted | Median | Inter-Quartile Range | score on a scale | Week 7 of Participation |
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| Secondary | Hamilton Depression Scale Score | Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56. | Available participants to be measured. | Posted | Median | Inter-Quartile Range | score on a scale | Week 8 of Participation |
|
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| Secondary | Hamilton Depression Scale Score | Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56. | Available participants to be measured. | Posted | Median | Inter-Quartile Range | score on a scale | Week 9 of Participation |
|
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| Secondary | Hamilton Depression Scale Score | Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56. | Available participants to be measured. | Posted | Median | Inter-Quartile Range | score on a scale | Week 10 of Participation |
|
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|
| Secondary | Hamilton Depression Scale Score | Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56. | Available participants to be measured. | Posted | Median | Inter-Quartile Range | score on a scale | Week 11 of Participation |
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| Secondary | Hamilton Depression Scale Score | Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56. | Available participants to be measured. | Posted | Median | Inter-Quartile Range | score on a scale | Week 12 of Participation |
|
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| Secondary | 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). | Available participants to be measured. | Posted | Mean | Standard Deviation | number of criteria met | At Baseline |
|
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| Secondary | 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). | Available participants to be measured. | Posted | Mean | Standard Deviation | number of criteria met | Week 12 of Participation |
|
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| Secondary | 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. | Available participants to be measured. | Posted | Mean | Standard Deviation | ln(ratio) | At Baseline |
|
|
|
| Secondary | 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. | Available participants to be measured. | Posted | Mean | Standard Deviation | ln(ratio) | Week 12 of participation |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 17 |
| 42 |
| EG001 | Low Value Alternative Reinforcer Group | This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples. | 0 | 41 | 0 | 41 | 15 | 41 |
| EG002 | High Value Alternative Reinforcer Group | This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples. | 0 | 44 | 0 | 44 | 20 | 44 |
| Chest Pain | Cardiac disorders | Systematic Assessment |
|
| Elevated Creatine Kinase | Renal and urinary disorders | Systematic Assessment |
|
| Skin Irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Difficult Blood Draw | Vascular disorders | Systematic Assessment |
|
| Unusual/Unpleasant Skin Sensation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Suicidal Ideation | Psychiatric disorders | Systematic Assessment |
|
Not provided
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