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Cocaine Use Reduction and Health (RCT (04))

W

William Stoops

Status

Completed

Conditions

Cocaine Use Disorder

Treatments

Behavioral: Contingency Management

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03224546
Randomized Clinical Trial (04)
R01DA043938 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

159 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Triple Blind

159 participants in 3 patient groups

Control Group
No Intervention group
Description:
This group will receive payment for providing urine samples throughout the trial.
Low Value Alternative Reinforcer Group
Experimental group
Description:
This group will receive payment for providing cocaine negative urine samples throughout the trial.
Treatment:
Behavioral: Contingency Management
High Value Alternative Reinforcer Group
Experimental group
Description:
This group will receive payment for providing cocaine negative urine samples throughout the trial.
Treatment:
Behavioral: Contingency Management

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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