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Completed

NCT Number: NCT03224546

Cocaine Use Reduction and Health

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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Key information

Conditions

Cocaine Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contingency Management

Behavioral

Subjects will receive payments for providing cocaine negative urine samples.

Primary outcomes

  1. Endothelin-1 Levels

    Time frame: At baseline.

    Endothelin-1 levels will be measured. They will be recorded in pg/ml.

  2. Endothelin-1 Levels

    Time frame: Week 6 of study participation

    Endothelin-1 levels will be measured. They will be recorded in pg/ml.

  3. Endothelin-1 Levels

    Time frame: Week 12 of study participation

    Endothelin-1 levels will be measured. They will be recorded in pg/ml.

  4. Mean Arterial Pressure

    Time frame: At baseline

    Mean Arterial Pressure is recorded during participant visits and is recorded in mm Hg

  5. Mean Arterial Pressure

    Time frame: Week 1 of participation

    Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

  6. Mean Arterial Pressure

    Time frame: Week 2 of participation

    Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

  7. Mean Arterial Pressure

    Time frame: Week 3 of participation

    Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

  8. Mean Arterial Pressure

    Time frame: Week 4 of participation

    Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

  9. Mean Arterial Pressure

    Time frame: Week 5 of participation

    Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

  10. Mean Arterial Pressure

    Time frame: Week 6 of participation

    Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

  11. Mean Arterial Pressure

    Time frame: Week 7 of participation

    Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

  12. Mean Arterial Pressure

    Time frame: Week 8 of participation

    Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

  13. Mean Arterial Pressure

    Time frame: Week 9 of participation

    Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

  14. Mean Arterial Pressure

    Time frame: Week 10 of participation

    Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

  15. Mean Arterial Pressure

    Time frame: Week 11 of participation

    Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

  16. Mean Arterial Pressure

    Time frame: Week 12 of participation

    Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

Secondary outcomes

  1. Interleukin-10

    Time frame: At baseline.

    Interleukin-10 levels will be measured throughout subject participation. They will be recorded in pg/ml.

  2. Interleukin-10

    Time frame: Week 6 of study participation

    Interleukin-10 levels will be measured throughout subject participation. They will be recorded in pg/ml.

  3. Interleukin-10

    Time frame: Week 12 of study participation

    Interleukin-10 levels will be measured throughout subject participation. They will be recorded in pg/ml.

  4. Total Sleep Time

    Time frame: At baseline

    Sleep time the night before in minutes

  5. Total Sleep Time

    Time frame: Week 1 of participation

    Sleep time the night before in minutes

  6. Total Sleep Time

    Time frame: Week 2 of participation

    Sleep time the night before in minutes

  7. Total Sleep Time

    Time frame: Week 3 of participation

    Sleep time the night before in minutes

  8. Total Sleep Time

    Time frame: Week 4 of participation

    Sleep time the night before in minutes

  9. Total Sleep Time

    Time frame: Week 5 of participation

    Sleep time the night before in minutes

  10. Total Sleep Time

    Time frame: Week 6 of participation

    Sleep time the night before in minutes

  11. Total Sleep Time

    Time frame: Week 7 of participation

    Sleep time the night before in minutes

  12. Total Sleep Time

    Time frame: Week 8 of participation

    Sleep time the night before in minutes

  13. Total Sleep Time

    Time frame: Week 9 of participation

    Sleep time the night before in minutes

  14. Total Sleep Time

    Time frame: Week 10 of participation

    Sleep time the night before in minutes

  15. Total Sleep Time

    Time frame: Week 11 of participation

    Sleep time the night before in minutes

  16. Total Sleep Time

    Time frame: Week 12 of participation

    Sleep time the night before in minutes

  17. Hamilton Depression Scale Score

    Time frame: At baseline

    Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.

  18. Hamilton Depression Scale Score

    Time frame: Week 1 of Participation

    Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.

  19. Hamilton Depression Scale Score

    Time frame: Week 2 of Participation

    Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.

  20. Hamilton Depression Scale Score

    Time frame: Week 3 of Participation

    Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.

  21. Hamilton Depression Scale Score

    Time frame: Week 4 of Participation

    Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.

  22. Hamilton Depression Scale Score

    Time frame: Week 5 of Participation

    Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.

  23. Hamilton Depression Scale Score

    Time frame: Week 6 of Participation

    Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.

  24. Hamilton Depression Scale Score

    Time frame: Week 7 of Participation

    Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.

  25. Hamilton Depression Scale Score

    Time frame: Week 8 of Participation

    Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.

  26. Hamilton Depression Scale Score

    Time frame: Week 9 of Participation

    Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.

  27. Hamilton Depression Scale Score

    Time frame: Week 10 of Participation

    Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.

  28. Hamilton Depression Scale Score

    Time frame: Week 11 of Participation

    Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.

  29. Hamilton Depression Scale Score

    Time frame: Week 12 of Participation

    Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.

  30. Criteria for Cocaine Use Disorder Diagnosis

    Time frame: At Baseline

    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).

  31. Criteria for Cocaine Use Disorder Diagnosis

    Time frame: 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).

  32. Reactive Hyperemia Index

    Time frame: At Baseline

    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.

  33. Reactive Hyperemia Index

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

William Stoops

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Cardiovascular, Immune and Psychosocial Benefits of Reduced Cocaine Use

Acronym: RCT (04)

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Jul 21, 2017
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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