Cocaine Use Reduction and Health

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

  • Cocaine Use Disorder

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Primary Purpose
Basic Science
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

More Details

NCT ID
NCT03224546
Status
Suspended
Sponsor
William Stoops