Cocaine Use Reduction and Health (RCT (04))

July 31, 2024 updated by: William Stoops

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
127

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Endothelin-1 Levels
Time Frame: At baseline.
Endothelin-1 levels will be measured. They will be recorded in pg/ml.
At baseline.
Endothelin-1 Levels
Time Frame: Week 6 of study participation
Endothelin-1 levels will be measured. They will be recorded in pg/ml.
Week 6 of study participation
Endothelin-1 Levels
Time Frame: Week 12 of study participation
Endothelin-1 levels will be measured. They will be recorded in pg/ml.
Week 12 of study participation
Mean Arterial Pressure
Time Frame: At baseline
Mean Arterial Pressure is recorded during participant visits and is recorded in mm Hg
At baseline
Mean Arterial Pressure
Time Frame: Week 1 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Week 1 of participation
Mean Arterial Pressure
Time Frame: Week 2 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Week 2 of participation
Mean Arterial Pressure
Time Frame: Week 3 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Week 3 of participation
Mean Arterial Pressure
Time Frame: Week 4 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Week 4 of participation
Mean Arterial Pressure
Time Frame: Week 5 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Week 5 of participation
Mean Arterial Pressure
Time Frame: Week 6 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Week 6 of participation
Mean Arterial Pressure
Time Frame: Week 7 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Week 7 of participation
Mean Arterial Pressure
Time Frame: Week 8 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Week 8 of participation
Mean Arterial Pressure
Time Frame: Week 9 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Week 9 of participation
Mean Arterial Pressure
Time Frame: Week 10 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Week 10 of participation
Mean Arterial Pressure
Time Frame: Week 11 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Week 11 of participation
Mean Arterial Pressure
Time Frame: Week 12 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Week 12 of participation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Interleukin-10
Time Frame: At baseline.
Interleukin-10 levels will be measured throughout subject participation. They will be recorded in pg/ml.
At baseline.
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.
Week 6 of study participation
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.
Week 12 of study participation
Total Sleep Time
Time Frame: At baseline
Sleep time the night before in minutes
At baseline
Total Sleep Time
Time Frame: Week 1 of participation
Sleep time the night before in minutes
Week 1 of participation
Total Sleep Time
Time Frame: Week 2 of participation
Sleep time the night before in minutes
Week 2 of participation
Total Sleep Time
Time Frame: Week 3 of participation
Sleep time the night before in minutes
Week 3 of participation
Total Sleep Time
Time Frame: Week 4 of participation
Sleep time the night before in minutes
Week 4 of participation
Total Sleep Time
Time Frame: Week 5 of participation
Sleep time the night before in minutes
Week 5 of participation
Total Sleep Time
Time Frame: Week 6 of participation
Sleep time the night before in minutes
Week 6 of participation
Total Sleep Time
Time Frame: Week 7 of participation
Sleep time the night before in minutes
Week 7 of participation
Total Sleep Time
Time Frame: Week 8 of participation
Sleep time the night before in minutes
Week 8 of participation
Total Sleep Time
Time Frame: Week 9 of participation
Sleep time the night before in minutes
Week 9 of participation
Total Sleep Time
Time Frame: Week 10 of participation
Sleep time the night before in minutes
Week 10 of participation
Total Sleep Time
Time Frame: Week 11 of participation
Sleep time the night before in minutes
Week 11 of participation
Total Sleep Time
Time Frame: Week 12 of participation
Sleep time the night before in minutes
Week 12 of participation
Hamilton Depression Scale Score
Time Frame: At baseline
Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
At baseline
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.
Week 1 of Participation
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.
Week 2 of Participation
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.
Week 3 of Participation
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.
Week 4 of Participation
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.
Week 5 of Participation
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.
Week 6 of Participation
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.
Week 7 of Participation
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.
Week 8 of Participation
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.
Week 9 of Participation
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.
Week 10 of Participation
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.
Week 11 of Participation
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.
Week 12 of Participation
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).
At Baseline
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).
Week 12 of Participation
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.
At Baseline
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.
Week 12 of participation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
William Stoops

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: William W Stoops, Ph.D., University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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