Cocaine Use Reduction and Health

NCT ID: NCT03224546

Last Updated: 2024-08-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-15

Study Completion Date

2024-01-15

Brief Summary

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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.

Detailed Description

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Conditions

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Cocaine Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Control Group

This group will receive payment for providing urine samples throughout the trial.

Group Type NO_INTERVENTION

No interventions assigned to this group

Low Value Alternative Reinforcer Group

This group will receive payment for providing cocaine negative urine samples throughout the trial.

Group Type EXPERIMENTAL

Contingency Management

Intervention Type BEHAVIORAL

Subjects will receive payments for providing cocaine negative urine samples.

High Value Alternative Reinforcer Group

This group will receive payment for providing cocaine negative urine samples throughout the trial.

Group Type EXPERIMENTAL

Contingency Management

Intervention Type BEHAVIORAL

Subjects will receive payments for providing cocaine negative urine samples.

Interventions

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Contingency Management

Subjects will receive payments for providing cocaine negative urine samples.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

William Stoops

OTHER

Sponsor Role lead

Responsible Party

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William Stoops

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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William W Stoops, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status

Countries

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United States

References

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Stoops WW, Shellenberg TP, Regnier SD, Cox DH, Adatorwovor R, Hays LR, Anderson DM, Lile JA, Schmitz JM, Havens JR, Segerstrom SC. Influence of cocaine use reduction on markers of immune function. J Neuroimmunol. 2024 Dec 15;397:578470. doi: 10.1016/j.jneuroim.2024.578470. Epub 2024 Oct 28.

Reference Type DERIVED
PMID: 39504756 (View on PubMed)

Regnier SD, Shellenberg TP, Koffarnus MN, Cox DH, Lile JA, Rush CR, Stoops WW. Cocaine abstinence during the "critical period" of a contingency management trial predicts future abstinence in people with cocaine use disorder. Drug Alcohol Depend. 2023 Dec 1;253:111030. doi: 10.1016/j.drugalcdep.2023.111030. Epub 2023 Nov 18.

Reference Type DERIVED
PMID: 38006674 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R01DA043938

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Randomized Clinical Trial (04)

Identifier Type: -

Identifier Source: org_study_id

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