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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
127
Subjects will receive payments for providing cocaine negative urine samples.
University of Kentucky
Lexington, Kentucky, United States
Endothelin-1 Levels
Endothelin-1 levels will be measured. They will be recorded in pg/ml.
Time frame: At baseline.
Endothelin-1 Levels
Endothelin-1 levels will be measured. They will be recorded in pg/ml.
Time frame: Week 6 of study participation
Endothelin-1 Levels
Endothelin-1 levels will be measured. They will be recorded in pg/ml.
Time frame: Week 12 of study participation
Mean Arterial Pressure
Mean Arterial Pressure is recorded during participant visits and is recorded in mm Hg
Time frame: At baseline
Mean Arterial Pressure
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Time frame: Week 1 of participation
Mean Arterial Pressure
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Time frame: Week 2 of participation
Mean Arterial Pressure
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Time frame: Week 3 of participation
Mean Arterial Pressure
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Time frame: Week 4 of participation
Mean Arterial Pressure
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Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Time frame: Week 5 of participation
Mean Arterial Pressure
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Time frame: Week 6 of participation
Mean Arterial Pressure
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Time frame: Week 7 of participation
Mean Arterial Pressure
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Time frame: Week 8 of participation
Mean Arterial Pressure
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Time frame: Week 9 of participation
Mean Arterial Pressure
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Time frame: Week 10 of participation
Mean Arterial Pressure
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Time frame: Week 11 of participation
Mean Arterial Pressure
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Time frame: Week 12 of participation
Interleukin-10
Interleukin-10 levels will be measured throughout subject participation. They will be recorded in pg/ml.
Time frame: At baseline.
Interleukin-10
Interleukin-10 levels will be measured throughout subject participation. They will be recorded in pg/ml.
Time frame: Week 6 of study participation
Interleukin-10
Interleukin-10 levels will be measured throughout subject participation. They will be recorded in pg/ml.
Time frame: Week 12 of study participation
Total Sleep Time
Sleep time the night before in minutes
Time frame: At baseline
Total Sleep Time
Sleep time the night before in minutes
Time frame: Week 1 of participation
Total Sleep Time
Sleep time the night before in minutes
Time frame: Week 2 of participation
Total Sleep Time
Sleep time the night before in minutes
Time frame: Week 3 of participation
Total Sleep Time
Sleep time the night before in minutes
Time frame: Week 4 of participation
Total Sleep Time
Sleep time the night before in minutes
Time frame: Week 5 of participation
Total Sleep Time
Sleep time the night before in minutes
Time frame: Week 6 of participation
Total Sleep Time
Sleep time the night before in minutes
Time frame: Week 7 of participation
Total Sleep Time
Sleep time the night before in minutes
Time frame: Week 8 of participation
Total Sleep Time
Sleep time the night before in minutes
Time frame: Week 9 of participation
Total Sleep Time
Sleep time the night before in minutes
Time frame: Week 10 of participation
Total Sleep Time
Sleep time the night before in minutes
Time frame: Week 11 of participation
Total Sleep Time
Sleep time the night before in minutes
Time frame: Week 12 of participation
Hamilton Depression Scale Score
Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Time frame: At baseline
Hamilton Depression Scale Score
Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Time frame: Week 1 of Participation
Hamilton Depression Scale Score
Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Time frame: Week 2 of Participation
Hamilton Depression Scale Score
Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Time frame: Week 3 of Participation
Hamilton Depression Scale Score
Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Time frame: Week 4 of Participation
Hamilton Depression Scale Score
Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Time frame: Week 5 of Participation
Hamilton Depression Scale Score
Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Time frame: Week 6 of Participation
Hamilton Depression Scale Score
Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Time frame: Week 7 of Participation
Hamilton Depression Scale Score
Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Time frame: Week 8 of Participation
Hamilton Depression Scale Score
Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Time frame: Week 9 of Participation
Hamilton Depression Scale Score
Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Time frame: Week 10 of Participation
Hamilton Depression Scale Score
Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Time frame: Week 11 of Participation
Hamilton Depression Scale Score
Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Week 12 of participation