NCT03224546

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2017

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
7 months until next milestone

Results Posted

Study results publicly available

August 1, 2024

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

6.3 years

First QC Date

July 18, 2017

Results QC Date

July 8, 2024

Last Update Submit

July 31, 2024

Conditions

Cocaine Use Disorder

Outcome Measures

Primary Outcomes (16)

  • Endothelin-1 Levels

    Endothelin-1 levels will be measured. They will be recorded in pg/ml.

    At baseline.

  • Endothelin-1 Levels

    Endothelin-1 levels will be measured. They will be recorded in pg/ml.

    Week 6 of study participation

  • Endothelin-1 Levels

    Endothelin-1 levels will be measured. They will be recorded in pg/ml.

    Week 12 of study participation

  • Mean Arterial Pressure

    Mean Arterial Pressure is recorded during participant visits and is recorded in mm Hg

    At baseline

  • Mean Arterial Pressure

    Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

    Week 1 of participation

  • Mean Arterial Pressure

    Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

    Week 2 of participation

  • Mean Arterial Pressure

    Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

    Week 3 of participation

  • Mean Arterial Pressure

    Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

    Week 4 of participation

  • Mean Arterial Pressure

    Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

    Week 5 of participation

  • Mean Arterial Pressure

    Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

    Week 6 of participation

  • Mean Arterial Pressure

    Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

    Week 7 of participation

  • Mean Arterial Pressure

    Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

    Week 8 of participation

  • Mean Arterial Pressure

    Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

    Week 9 of participation

  • Mean Arterial Pressure

    Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

    Week 10 of participation

  • Mean Arterial Pressure

    Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

    Week 11 of participation

  • Mean Arterial Pressure

    Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

    Week 12 of participation

Secondary Outcomes (33)

  • Interleukin-10

    At baseline.

  • Interleukin-10

    Week 6 of study participation

  • Interleukin-10

    Week 12 of study participation

  • Total Sleep Time

    At baseline

  • Total Sleep Time

    Week 1 of participation

  • +28 more secondary outcomes

Study Arms (3)

Control Group

NO INTERVENTION

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

Low Value Alternative Reinforcer Group

EXPERIMENTAL

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

Behavioral: Contingency Management

High Value Alternative Reinforcer Group

EXPERIMENTAL

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

Behavioral: Contingency Management

Interventions

Contingency ManagementBEHAVIORAL

Subjects will receive payments for providing cocaine negative urine samples.

High Value Alternative Reinforcer GroupLow Value Alternative Reinforcer Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Publications (3)

  • Ferretti ML, Regnier SD, Irons JG, Stoops WW. Polysubstance use patterns and risk behaviors among people with cocaine use disorder. Exp Clin Psychopharmacol. 2025 Dec;33(6):586-593. doi: 10.1037/pha0000813.

    PMID: 41343351DERIVED

  • 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.

    PMID: 39504756DERIVED

  • 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.

    PMID: 38006674DERIVED

Results Point of Contact

Title
William W. Stoops
Organization
University of Kentucky
william.stoops@uky.edu
859-257-5383

Study Officials

  • William W Stoops, Ph.D.

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 18, 2017

First Posted

July 21, 2017

Study Start

September 15, 2017

Primary Completion

January 15, 2024

Study Completion

January 15, 2024

Last Updated

August 1, 2024

Results First Posted

August 1, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(1)