Cocaine Use Reduction and Health (RCT (04))

• ClinicalTrials.gov Identifier: NCT03224546
• Recruitment Status: Recruiting
• First Posted: July 21, 2017
• Last Update Posted: December 5, 2022
• Sponsor: William Stoops
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): William Stoops, University of Kentucky

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cocaine Use Disorder	Behavioral: Contingency Management	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Cardiovascular, Immune and Psychosocial Benefits of Reduced Cocaine Use
• Actual Study Start Date: September 15, 2017
• Estimated Primary Completion Date: October 14, 2023
• Estimated Study Completion Date: October 14, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Endothelin-1 levels [ Time Frame: At baseline ]
   Endothelin-1 levels will be measured throughout subject participation. They will be recorded in pg/ml.
2. Systolic blood pressure [ Time Frame: At baseline ]
   Systolic blood pressure will be recorded during subject visits. Systolic blood pressure will be recorded in mmHg
3. Diastolic blood pressure [ Time Frame: At baseline ]
   Diastolic blood pressure will be recorded during subject visits. Systolic blood pressure will be recorded in mmHg
4. Heart rate [ Time Frame: At baseline ]
   Heart rate will be recorded during subject visits. Systolic blood pressure will be recorded in beats per minute
5. Cocaine use [ Time Frame: At baseline ]
   Cocaine use will be assessed with qualitative urine screens during subject visits. Results will be coded as positive or negative.
6. Peripheral arterial tonometry (PAT) [ Time Frame: At baseline ]
   PAT will be asssessed using the Endo-PAT2000 system. The outcome will be recorded as the reactive hyperemia index.
7. Electrocardiogram [ Time Frame: At baseline, 12 weeks after study entry, 4, 12 and 24 weeks after study completion. ]
   Electrocardiograms will be completed throughout study participation.
8. Endothelin-1 levels [ Time Frame: 6 weeks after study entry. ]
   Endothelin-1 levels will be measured. They will be recorded in pg/ml.
9. Endothelin-1 levels [ Time Frame: 12 weeks after study entry. ]
   Endothelin-1 levels will be measured. They will be recorded in pg/ml.
10. Endothelin-1 levels [ Time Frame: 4 weeks after study completion ]
    Endothelin-1 levels will be measured. They will be recorded in pg/ml.
11. Endothelin-1 levels [ Time Frame: 12 weeks after study completion ]
    Endothelin-1 levels will be measured. They will be recorded in pg/ml.
12. Endothelin-1 levels [ Time Frame: 24 weeks after study completion ]
    Endothelin-1 levels will be measured. They will be recorded in pg/ml.
13. Systolic blood pressure [ Time Frame: Change from baseline across the 12 week intervention ]
    Systolic blood pressure will be recorded during subject visits. Systolic blood pressure will be recorded in mmHg
14. Systolic blood pressure [ Time Frame: 4 weeks after study completion ]
    Systolic blood pressure will be recorded during subject visits. Systolic blood pressure will be recorded in mmHg
15. Systolic blood pressure [ Time Frame: 8 weeks after study completion ]
    Systolic blood pressure will be recorded during subject visits. Systolic blood pressure will be recorded in mmHg
16. Systolic blood pressure [ Time Frame: 12 weeks after study completion ]
    Systolic blood pressure will be recorded during subject visits. Systolic blood pressure will be recorded in mmHg
17. Systolic blood pressure [ Time Frame: 24 weeks after study completion ]
    Systolic blood pressure will be recorded during subject visits. Systolic blood pressure will be recorded in mmHg
18. Diastolic blood pressure [ Time Frame: Change from baseline across the 12 week intervention ]
    Diastolic blood pressure will be recorded during subject visits. Diastolic blood pressure will be recorded in mmHg
19. Diastolic blood pressure [ Time Frame: 4 weeks after study completion ]
    Diastolic blood pressure will be recorded during subject visits. Diastolic blood pressure will be recorded in mmHg
20. Diastolic blood pressure [ Time Frame: 8 weeks after study completion ]
    Diastolic blood pressure will be recorded during subject visits. Diastolic blood pressure will be recorded in mmHg
21. Diastolic blood pressure [ Time Frame: 12 weeks after study completion ]
    Diastolic blood pressure will be recorded during subject visits. Diastolic blood pressure will be recorded in mmHg
22. Diastolic blood pressure [ Time Frame: 24 weeks after study completion ]
    Diastolic blood pressure will be recorded during subject visits. Diastolic blood pressure will be recorded in mmHg
23. Heart rate [ Time Frame: Change from baseline across the 12 week intervention ]
    Heart rate will be recorded during subject visits. Heart rate will be recorded in beats per minute
24. Heart rate [ Time Frame: 4 weeks after study completion ]
    Heart rate will be recorded during subject visits. Heart rate will be recorded in beats per minute
25. Heart rate [ Time Frame: 8 weeks after study completion ]
    Heart rate will be recorded during subject visits. Heart rate will be recorded in beats per minute
26. Heart rate [ Time Frame: 12 weeks after study completion ]
    Heart rate will be recorded during subject visits. Heart rate will be recorded in beats per minute
27. Heart rate [ Time Frame: 24 weeks after study completion ]
    Heart rate will be recorded during subject visits. Heart rate will be recorded in beats per minute
28. Cocaine use [ Time Frame: Change from baseline across the 12 week intervention ]
    Cocaine use will be assessed with qualitative urine screens during subject visits. Results will be coded as positive or negative.
29. Cocaine use [ Time Frame: 4 weeks after study completion ]
    Cocaine use will be assessed with qualitative urine screens during subject visits. Results will be coded as positive or negative.
30. Cocaine use [ Time Frame: 8 weeks after study completion ]
    Cocaine use will be assessed with qualitative urine screens during subject visits. Results will be coded as positive or negative.
31. Cocaine use [ Time Frame: 12 weeks after study completion ]
    Cocaine use will be assessed with qualitative urine screens during subject visits. Results will be coded as positive or negative.
32. Cocaine use [ Time Frame: 24 weeks after study completion ]
    Cocaine use will be assessed with qualitative urine screens during subject visits. Results will be coded as positive or negative.
33. Peripheral arterial tonometry (PAT) [ Time Frame: 12 weeks after study entry ]
    PAT will be asssessed using the Endo-PAT2000 system. The outcome will be recorded as the reactive hyperemia index.
34. Peripheral arterial tonometry (PAT) [ Time Frame: 4 weeks after study completion ]
    PAT will be asssessed using the Endo-PAT2000 system. The outcome will be recorded as the reactive hyperemia index.
35. Peripheral arterial tonometry (PAT) [ Time Frame: 8 weeks after study completion ]
    PAT will be asssessed using the Endo-PAT2000 system. The outcome will be recorded as the reactive hyperemia index.
36. Peripheral arterial tonometry (PAT) [ Time Frame: 12 weeks after study completion ]
    PAT will be asssessed using the Endo-PAT2000 system. The outcome will be recorded as the reactive hyperemia index.
37. Peripheral arterial tonometry (PAT) [ Time Frame: 24 weeks after study completion ]
    PAT will be asssessed using the Endo-PAT2000 system. The outcome will be recorded as the reactive hyperemia index.
38. Electrocardiogram [ Time Frame: 12 weeks after study entry ]
    Electrocardiograms will be completed.
39. Electrocardiogram [ Time Frame: 4 weeks after study completion ]
    Electrocardiograms will be completed.
40. Electrocardiogram [ Time Frame: 12 weeks after study completion ]
    Electrocardiograms will be completed.
41. Electrocardiogram [ Time Frame: 24 weeks after study completion ]
    Electrocardiograms will be completed.

Secondary Outcome Measures :

1. Delayed type hypersensitivity to candida yeast [ Time Frame: At baseline, 6 and 12 weeks after study entry, 4, 12 and 24 weeks after study completion. ]
   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
2. Interleukin-10 [ Time Frame: At baseline, 6 and 12 weeks after study entry, 4, 12 and 24 weeks after study completion. ]
   Interleukin-10 levels will be measured throughout subject participation. They will be recorded in pg/ml.
3. Weight [ Time Frame: At baseline, 3 days/week during the 12 week intervention, 4, 8, 12 and 24 weeks after study completion ]
   Weight will be recorded in kilograms throughout subject participation.
4. Sleep [ Time Frame: At baseline, 1 time weekly during the 12 week intervention, 4, 8, 12 and 24 weeks after study completion ]
   Sleep will be assessed with the Saint Mary's Hospital Sleep questionnaire throughout subject participation.
5. Depression [ Time Frame: At baseline, 1 time weekly during the 12 week intervention, 4, 8, 12 and 24 weeks after study completion ]
   Depressive symptoms will be assessed with the Hamilton Depression Scale throughout subject participation.
6. HIV Risk Behavior [ Time Frame: At baseline, 1 time weekly during the 12 week intervention, 4, 8, 12 and 24 weeks after study completion ]
   HIV Risk Behavior will be assessed with the HIV Risk Behavior Scale throughout subject participation.
7. Addiction Severity [ Time Frame: At baseline, weeks 4, 8 and 12 during the 12 week intervention, 4, 8, 12 and 24 weeks after study completion ]
   Addiction severity will be assessed with the Addiction Severity Index-lite throughout subject participation.
8. Drug use [ Time Frame: At baseline, weeks 4, 8 and 12 during the 12 week intervention, 4, 8, 12 and 24 weeks after study completion ]
   Drug use will be assessed with the Timeline Followback Scale throughout subject participation.
9. Drug use [ Time Frame: At baseline, 3 times weekly during the 12 week intervention, 4, 8, 12 and 24 weeks after study completion ]
   Drug use will be assessed with qualitative urine screens throughout subject participation. Results will be coded as positive or negative.
10. Cocaine use disorder [ Time Frame: At baseline, week 12 of study participation, 4, 12 and 24 weeks after study completion ]
    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.
11. Adverse events [ Time Frame: At baseline, 1 time weekly during the 12 week intervention, 4, 8, 12 and 24 weeks after study completion ]
    Adverse events will be queried throughout study participation.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: William W Stoops, Ph.D.; 8592575388; william.stoops@uky.edu

Locations

United States, Kentucky

University of Kentucky; Recruiting

Lexington, Kentucky, United States, 40536

Contact: William W Stoops, Ph.D. 859-257-5388 william.stoops@uky.edu

Sponsors and Collaborators

William Stoops

National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: William W Stoops, Ph.D.; University of Kentucky

More Information

• Responsible Party: William Stoops, Professor, University of Kentucky
• ClinicalTrials.gov Identifier: NCT03224546
• Other Study ID Numbers: Randomized Clinical Trial (04); R01DA043938 ( U.S. NIH Grant/Contract )
• First Posted: July 21, 2017
• Last Update Posted: December 5, 2022
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No