Cocaine Use Reduction and Health

Not Applicable

Completed

Brief 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. 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Low Value Alternative Reinforcer Group	Contingency Management	This group will receive payment for providing cocaine negative urine samples throughout the trial.
High Value Alternative Reinforcer Group	Contingency Management	This group will receive payment for providing cocaine negative urine samples throughout the trial.

Primary Outcome Measures

Name	Time	Method
Endothelin-1 Levels	Week 12 of study participation	Endothelin-1 levels will be measured. They will be recorded in pg/ml.
Mean Arterial Pressure	Week 12 of participation	Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

Secondary Outcome Measures

Name	Time	Method
Interleukin-10	Week 12 of study participation	Interleukin-10 levels will be measured throughout subject participation. They will be recorded in pg/ml.
Hamilton Depression Scale Score	Week 12 of Participation	Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Criteria for Cocaine Use Disorder Diagnosis	Week 12 of Participation	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).
Total Sleep Time	Week 12 of participation	Sleep time the night before in minutes
Reactive Hyperemia Index	Week 12 of participation	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.