NCT03937986

Brief Summary

The research proposed here will translate findings from preclinical research and provide the initial clinical evidence that orexin antagonism reduces motivation for cocaine, as well as other cocaine-associated maladaptive behaviors in active cocaine users. This study will also provide basic science information about the orexinergic mechanisms underlying the pharmacodynamic effects of cocaine in humans. As such the outcomes will contribute to our understanding of the clinical neurobiology of cocaine use disorder. Overall, the proposed work seeks to expand the scope of current clinical neuroscience research on cocaine addiction by focusing on orexin, which has strong preclinical evidence supporting its critical role in addiction but remains unstudied in humans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jul 2019

Typical duration for early_phase_1

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

May 2, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

July 11, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
9 months until next milestone

Results Posted

Study results publicly available

February 8, 2023

Completed
Last Updated

February 9, 2023

Status Verified

February 1, 2023

Enrollment Period

2.8 years

First QC Date

May 2, 2019

Results QC Date

January 11, 2023

Last Update Submit

February 7, 2023

Conditions

Cocaine Use Disorder

Outcome Measures

Primary Outcomes (1)

  • Reinforcing Effects of Cocaine

    Number of Times Subjects Choose Cocaine (Maximum of 10 Choices) Over Money

    12 times over approximately 1 month inpatient admission.

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Subjects will be maintained on oral placebo. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.

Drug: CocaineDrug: Placebo oral capsule

Suvorexant Dose 1

EXPERIMENTAL

Subjects will be maintained on oral suvorexant dose 1. Cocaine will be administered acutely during suvorexant dose 1 maintenance. Placebo will be administered acutely during suvorexant dose 1 maintenance.

Drug: SuvorexantDrug: Cocaine

Suvorexant Dose 2

EXPERIMENTAL

Subjects will be maintained on oral suvorexant dose 2. Cocaine will be administered acutely during suvorexant dose 2 maintenance. Placebo will be administered acutely during suvorexant dose 2 maintenance.

Drug: SuvorexantDrug: Cocaine

Suvorexant Dose 3

EXPERIMENTAL

Subjects will be maintained on oral suvorexant dose 3. Cocaine will be administered acutely during suvorexant dose 3 maintenance. Placebo will be administered acutely during suvorexant dose 3 maintenance.

Drug: SuvorexantDrug: Cocaine

Interventions

SuvorexantDRUG

The pharmacodynamic effects of suvorexant maintenance will be determined.

Suvorexant Dose 1Suvorexant Dose 2Suvorexant Dose 3
CocaineDRUG

The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and suvorexant.

PlaceboSuvorexant Dose 1Suvorexant Dose 2Suvorexant Dose 3
Placebo oral capsuleDRUG

The pharmacodynamic effects of placebo will be determined.

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Recent cocaine use

You may not qualify if:

  • Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
  • Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
  • History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
  • Females not currently using effective birth control
  • Contraindications to cocaine, methylphenidate or duloxetine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40507, United States

Location

MeSH Terms

Interventions

suvorexantCocaine

Intervention Hierarchy (Ancestors)

TropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Results Point of Contact

Title
William W. Stoops
Organization
University of Kentucky
william.stoops@uky.edu
859-257-5388

Study Officials

  • William W Stoops, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 2, 2019

First Posted

May 6, 2019

Study Start

July 11, 2019

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

February 9, 2023

Results First Posted

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)