Cocaine Use Reduction and Health

Study Overview
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Brief Summary
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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.

Official Title
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Cardiovascular, Immune and Psychosocial Benefits of Reduced Cocaine Use

Conditions
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Cocaine Use Disorder

Intervention / Treatment
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* Behavioral: Contingency Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>This group will receive payment for providing urine samples throughout the trial. | |
| Experimental: Low Value Alternative Reinforcer Group<br>This group will receive payment for providing cocaine negative urine samples throughout the trial. | Behavioral: Contingency Management<br>* Subjects will receive payments for providing cocaine negative urine samples.<br>|
| Experimental: High Value Alternative Reinforcer Group<br>This group will receive payment for providing cocaine negative urine samples throughout the trial. | Behavioral: Contingency Management<br>* Subjects will receive payments for providing cocaine negative urine samples.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelin-1 levels | Endothelin-1 levels will be measured throughout subject participation. They will be recorded in pg/ml. | At baseline | 
| Systolic blood pressure | Systolic blood pressure will be recorded during subject visits. Systolic blood pressure will be recorded in mmHg | At baseline | 
| Diastolic blood pressure | Diastolic blood pressure will be recorded during subject visits. Systolic blood pressure will be recorded in mmHg | At baseline | 
| Heart rate | Heart rate will be recorded during subject visits. Systolic blood pressure will be recorded in beats per minute | At baseline | 
| Cocaine use | Cocaine use will be assessed with qualitative urine screens during subject visits. Results will be coded as positive or negative. | At baseline | 
| Peripheral arterial tonometry (PAT) | PAT will be asssessed using the Endo-PAT2000 system. The outcome will be recorded as the reactive hyperemia index. | At baseline | 
| Electrocardiogram | Electrocardiograms will be completed throughout study participation. | At baseline, 12 weeks after study entry, 4, 12 and 24 weeks after study completion. | 
| Endothelin-1 levels | Endothelin-1 levels will be measured. They will be recorded in pg/ml. | 6 weeks after study entry. | 
| Endothelin-1 levels | Endothelin-1 levels will be measured. They will be recorded in pg/ml. | 12 weeks after study entry. | 
| Endothelin-1 levels | Endothelin-1 levels will be measured. They will be recorded in pg/ml. | 4 weeks after study completion | 
| Endothelin-1 levels | Endothelin-1 levels will be measured. They will be recorded in pg/ml. | 12 weeks after study completion | 
| Endothelin-1 levels | Endothelin-1 levels will be measured. They will be recorded in pg/ml. | 24 weeks after study completion | 
| Systolic blood pressure | Systolic blood pressure will be recorded during subject visits. Systolic blood pressure will be recorded in mmHg | Change from baseline across the 12 week intervention | 
| Systolic blood pressure | Systolic blood pressure will be recorded during subject visits. Systolic blood pressure will be recorded in mmHg | 4 weeks after study completion | 
| Systolic blood pressure | Systolic blood pressure will be recorded during subject visits. Systolic blood pressure will be recorded in mmHg | 8 weeks after study completion | 
| Systolic blood pressure | Systolic blood pressure will be recorded during subject visits. Systolic blood pressure will be recorded in mmHg | 12 weeks after study completion | 
| Systolic blood pressure | Systolic blood pressure will be recorded during subject visits. Systolic blood pressure will be recorded in mmHg | 24 weeks after study completion | 
| Diastolic blood pressure | Diastolic blood pressure will be recorded during subject visits. Diastolic blood pressure will be recorded in mmHg | Change from baseline across the 12 week intervention | 
| Diastolic blood pressure | Diastolic blood pressure will be recorded during subject visits. Diastolic blood pressure will be recorded in mmHg | 4 weeks after study completion | 
| Diastolic blood pressure | Diastolic blood pressure will be recorded during subject visits. Diastolic blood pressure will be recorded in mmHg | 8 weeks after study completion | 
| Diastolic blood pressure | Diastolic blood pressure will be recorded during subject visits. Diastolic blood pressure will be recorded in mmHg | 12 weeks after study completion | 
| Diastolic blood pressure | Diastolic blood pressure will be recorded during subject visits. Diastolic blood pressure will be recorded in mmHg | 24 weeks after study completion | 
| Heart rate | Heart rate will be recorded during subject visits. Heart rate will be recorded in beats per minute | Change from baseline across the 12 week intervention | 
| Heart rate | Heart rate will be recorded during subject visits. Heart rate will be recorded in beats per minute | 4 weeks after study completion | 
| Heart rate | Heart rate will be recorded during subject visits. Heart rate will be recorded in beats per minute | 8 weeks after study completion | 
| Heart rate | Heart rate will be recorded during subject visits. Heart rate will be recorded in beats per minute | 12 weeks after study completion | 
| Heart rate | Heart rate will be recorded during subject visits. Heart rate will be recorded in beats per minute | 24 weeks after study completion | 
| Cocaine use | Cocaine use will be assessed with qualitative urine screens during subject visits. Results will be coded as positive or negative. | Change from baseline across the 12 week intervention | 
| Cocaine use | Cocaine use will be assessed with qualitative urine screens during subject visits. Results will be coded as positive or negative. | 4 weeks after study completion | 
| Cocaine use | Cocaine use will be assessed with qualitative urine screens during subject visits. Results will be coded as positive or negative. | 8 weeks after study completion | 
| Cocaine use | Cocaine use will be assessed with qualitative urine screens during subject visits. Results will be coded as positive or negative. | 12 weeks after study completion | 
| Cocaine use | Cocaine use will be assessed with qualitative urine screens during subject visits. Results will be coded as positive or negative. | 24 weeks after study completion | 
| Peripheral arterial tonometry (PAT) | PAT will be asssessed using the Endo-PAT2000 system. The outcome will be recorded as the reactive hyperemia index. | 12 weeks after study entry | 
| Peripheral arterial tonometry (PAT) | PAT will be asssessed using the Endo-PAT2000 system. The outcome will be recorded as the reactive hyperemia index. | 4 weeks after study completion | 
| Peripheral arterial tonometry (PAT) | PAT will be asssessed using the Endo-PAT2000 system. The outcome will be recorded as the reactive hyperemia index. | 8 weeks after study completion | 
| Peripheral arterial tonometry (PAT) | PAT will be asssessed using the Endo-PAT2000 system. The outcome will be recorded as the reactive hyperemia index. | 12 weeks after study completion | 
| Peripheral arterial tonometry (PAT) | PAT will be asssessed using the Endo-PAT2000 system. The outcome will be recorded as the reactive hyperemia index. | 24 weeks after study completion | 
| Electrocardiogram | Electrocardiograms will be completed. | 12 weeks after study entry | 
| Electrocardiogram | Electrocardiograms will be completed. | 4 weeks after study completion | 
| Electrocardiogram | Electrocardiograms will be completed. | 12 weeks after study completion | 
| Electrocardiogram | Electrocardiograms will be completed. | 24 weeks after study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delayed type hypersensitivity to candida yeast | Delayed type hypersensitivity to candida yeast will be determined throughout the trial. The outcome will be measured as the mean of the longest and orthogonal diameters of each induration using the ballpoint pen method, in which a line is drawn with a ballpoint pen toward the margin of the reaction. When resistance due to induration is encountered, the pen is lifted. This method defines the margins of the induration | At baseline, 6 and 12 weeks after study entry, 4, 12 and 24 weeks after study completion. | 
| Interleukin-10 | Interleukin-10 levels will be measured throughout subject participation. They will be recorded in pg/ml. | At baseline, 6 and 12 weeks after study entry, 4, 12 and 24 weeks after study completion. | 
| Weight | Weight will be recorded in kilograms throughout subject participation. | At baseline, 3 days/week during the 12 week intervention, 4, 8, 12 and 24 weeks after study completion | 
| Sleep | Sleep will be assessed with the Saint Mary's Hospital Sleep questionnaire throughout subject participation. | At baseline, 1 time weekly during the 12 week intervention, 4, 8, 12 and 24 weeks after study completion | 
| Depression | Depressive symptoms will be assessed with the Hamilton Depression Scale throughout subject participation. | At baseline, 1 time weekly during the 12 week intervention, 4, 8, 12 and 24 weeks after study completion | 
| HIV Risk Behavior | HIV Risk Behavior will be assessed with the HIV Risk Behavior Scale throughout subject participation. | At baseline, 1 time weekly during the 12 week intervention, 4, 8, 12 and 24 weeks after study completion | 
| Addiction Severity | Addiction severity will be assessed with the Addiction Severity Index-lite throughout subject participation. | At baseline, weeks 4, 8 and 12 during the 12 week intervention, 4, 8, 12 and 24 weeks after study completion | 
| Drug use | Drug use will be assessed with the Timeline Followback Scale throughout subject participation. | At baseline, weeks 4, 8 and 12 during the 12 week intervention, 4, 8, 12 and 24 weeks after study completion | 
| Drug use | Drug use will be assessed with qualitative urine screens throughout subject participation. Results will be coded as positive or negative. | At baseline, 3 times weekly during the 12 week intervention, 4, 8, 12 and 24 weeks after study completion | 
| Cocaine use disorder | Cocaine use disorder severity will be assessed with the structured clinical interview for DSM-5 throughout study participation. Results will be coded as none, mild, moderate or sever. | At baseline, week 12 of study participation, 4, 12 and 24 weeks after study completion | 
| Adverse events | Adverse events will be queried throughout study participation. | At baseline, 1 time weekly during the 12 week intervention, 4, 8, 12 and 24 weeks after study completion |