Clinical trial NCT03224546: Cocaine Use Reduction and Health
Official title: Cardiovascular, Immune and Psychosocial Benefits of Reduced Cocaine Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cocaine Use Disorder
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-07-21
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Endothelin-1 Levels
timeFrame: At baseline.
measure: Endothelin-1 Levels
timeFrame: Week 6 of study participation
measure: Endothelin-1 Levels
timeFrame: Week 12 of study participation
measure: Mean Arterial Pressure
timeFrame: At baseline
measure: Mean Arterial Pressure
timeFrame: Week 1 of participation
measure: Mean Arterial Pressure
timeFrame: Week 2 of participation
measure: Mean Arterial Pressure
timeFrame: Week 3 of participation
measure: Mean Arterial Pressure
timeFrame: Week 4 of participation
measure: Mean Arterial Pressure
timeFrame: Week 5 of participation
measure: Mean Arterial Pressure
timeFrame: Week 6 of participation
measure: Mean Arterial Pressure
timeFrame: Week 7 of participation
measure: Mean Arterial Pressure
timeFrame: Week 8 of participation
measure: Mean Arterial Pressure
timeFrame: Week 9 of participation
measure: Mean Arterial Pressure
timeFrame: Week 10 of participation
measure: Mean Arterial Pressure
timeFrame: Week 11 of participation
measure: Mean Arterial Pressure
timeFrame: Week 12 of participation
Secondary outcomes:
measure: Interleukin-10
timeFrame: At baseline.
measure: Interleukin-10
timeFrame: Week 6 of study participation
measure: Interleukin-10
timeFrame: Week 12 of study participation
measure: Total Sleep Time
timeFrame: At baseline
measure: Total Sleep Time
timeFrame: Week 1 of participation
measure: Total Sleep Time
timeFrame: Week 2 of participation
measure: Total Sleep Time
timeFrame: Week 3 of participation
measure: Total Sleep Time
timeFrame: Week 4 of participation
measure: Total Sleep Time
timeFrame: Week 5 of participation
measure: Total Sleep Time
timeFrame: Week 6 of participation
measure: Total Sleep Time
timeFrame: Week 7 of participation
measure: Total Sleep Time
timeFrame: Week 8 of participation
measure: Total Sleep Time
timeFrame: Week 9 of participation
measure: Total Sleep Time
timeFrame: Week 10 of participation
measure: Total Sleep Time
timeFrame: Week 11 of participation
measure: Total Sleep Time
timeFrame: Week 12 of participation
measure: Hamilton Depression Scale Score
timeFrame: At baseline
measure: Hamilton Depression Scale Score
timeFrame: Week 1 of Participation
measure: Hamilton Depression Scale Score
timeFrame: Week 2 of Participation
measure: Hamilton Depression Scale Score
timeFrame: Week 3 of Participation
measure: Hamilton Depression Scale Score
timeFrame: Week 4 of Participation
measure: Hamilton Depression Scale Score
timeFrame: Week 5 of Participation
measure: Hamilton Depression Scale Score
timeFrame: Week 6 of Participation
measure: Hamilton Depression Scale Score
timeFrame: Week 7 of Participation
measure: Hamilton Depression Scale Score
timeFrame: Week 8 of Participation
measure: Hamilton Depression Scale Score
timeFrame: Week 9 of Participation
measure: Hamilton Depression Scale Score
timeFrame: Week 10 of Participation
measure: Hamilton Depression Scale Score
timeFrame: Week 11 of Participation
measure: Hamilton Depression Scale Score
timeFrame: Week 12 of Participation
measure: Criteria for Cocaine Use Disorder Diagnosis
timeFrame: At Baseline
measure: Criteria for Cocaine Use Disorder Diagnosis
timeFrame: Week 12 of Participation
measure: Reactive Hyperemia Index
timeFrame: At Baseline
measure: Reactive Hyperemia Index
timeFrame: Week 12 of participation
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: William W Stoops, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: