We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 6 for:    Stoops | Recruiting, Not yet recruiting Studies | Cocaine Use Disorder | United States, Kentucky
Previous Study | Return to List | Next Study

Cocaine Use Reduction and Health (RCT (04))

This study is currently recruiting participants.
Verified October 2017 by William Stoops, University of Kentucky
Sponsor:
ClinicalTrials.gov Identifier:
NCT03224546
First Posted: July 21, 2017
Last Update Posted: October 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
William Stoops, University of Kentucky
  Purpose
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 Intervention
Cocaine Use Disorder Behavioral: Contingency Management

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by William Stoops, University of Kentucky:

Primary Outcome Measures:
  • Endothelin-1 levels [ Time Frame: At baseline ]
    Endothelin-1 levels will be measured throughout subject participation. They will be recorded in pg/ml.

  • Systolic blood pressure [ Time Frame: At baseline ]
    Systolic blood pressure will be recorded during subject visits. Systolic blood pressure will be recorded in mmHg

  • Diastolic blood pressure [ Time Frame: At baseline ]
    Diastolic blood pressure will be recorded during subject visits. Systolic blood pressure will be recorded in mmHg

  • Heart rate [ Time Frame: At baseline ]
    Heart rate will be recorded during subject visits. Systolic blood pressure will be recorded in beats per minute

  • 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.

  • 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.

  • 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.

  • Endothelin-1 levels [ Time Frame: 6 weeks after study entry. ]
    Endothelin-1 levels will be measured. They will be recorded in pg/ml.

  • Endothelin-1 levels [ Time Frame: 12 weeks after study entry. ]
    Endothelin-1 levels will be measured. They will be recorded in pg/ml.

  • Endothelin-1 levels [ Time Frame: 4 weeks after study completion ]
    Endothelin-1 levels will be measured. They will be recorded in pg/ml.

  • Endothelin-1 levels [ Time Frame: 12 weeks after study completion ]
    Endothelin-1 levels will be measured. They will be recorded in pg/ml.

  • Endothelin-1 levels [ Time Frame: 24 weeks after study completion ]
    Endothelin-1 levels will be measured. They will be recorded in pg/ml.

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Electrocardiogram [ Time Frame: 12 weeks after study entry ]
    Electrocardiograms will be completed.

  • Electrocardiogram [ Time Frame: 4 weeks after study completion ]
    Electrocardiograms will be completed.

  • Electrocardiogram [ Time Frame: 12 weeks after study completion ]
    Electrocardiograms will be completed.

  • Electrocardiogram [ Time Frame: 24 weeks after study completion ]
    Electrocardiograms will be completed.


Secondary Outcome Measures:
  • 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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Estimated Enrollment: 250
Actual Study Start Date: September 15, 2017
Estimated Study Completion Date: October 14, 2022
Estimated Primary Completion Date: October 14, 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03224546


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     History of Changes
Other Study ID Numbers: Randomized Clinical Trial (04)
R01DA043938 ( U.S. NIH Grant/Contract )
First Submitted: July 18, 2017
First Posted: July 21, 2017
Last Update Posted: October 4, 2017
Last Verified: October 2017
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

Additional relevant MeSH terms:
Cocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents