Cocaine Use Reduction and Health (RCT (04))

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.

Study Overview

• Status: Completed
• Conditions: Cocaine Use Disorder
• Intervention / Treatment: Behavioral: Contingency Management

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University Of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: William Stoops
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: William W Stoops, Ph.D., University Of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2017
• Primary Completion (Actual): January 15, 2024
• Study Completion (Actual): January 15, 2024

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Randomized Clinical Trial (04); R01DA043938 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No