Suvorexant and Cocaine

February 7, 2023 updated by: William Stoops

Influence of Orexin Antagonism on Motivation for Cocaine

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kentucky
      • Lexington, Kentucky, United States, 40507
        • University Of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Recent cocaine use

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Subjects will be maintained on oral placebo. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and suvorexant.
The pharmacodynamic effects of placebo will be determined.
EXPERIMENTAL: Suvorexant Dose 1
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.
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and suvorexant.
The pharmacodynamic effects of suvorexant maintenance will be determined.
EXPERIMENTAL: Suvorexant Dose 2
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.
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and suvorexant.
The pharmacodynamic effects of suvorexant maintenance will be determined.
EXPERIMENTAL: Suvorexant Dose 3
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.
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and suvorexant.
The pharmacodynamic effects of suvorexant maintenance will be determined.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reinforcing Effects of Cocaine
Time Frame: 12 times over approximately 1 month inpatient admission.
Number of Times Subjects Choose Cocaine (Maximum of 10 Choices) Over Money
12 times over approximately 1 month inpatient admission.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjective Rating Scale-Sedative
Time Frame: 12 times over approximately 1 month inpatient admission
Subjects will complete the adjective rating scale during 12 sessions while they are admitted to our inpatient unit. Responses to 16 items are summed (total score=0-64; Higher values=more sedation) to calculate scores on a sedative subscale.
12 times over approximately 1 month inpatient admission
Adjective Rating Scale-Stimulant
Time Frame: 12 times over approximately 1 month inpatient admission
Subjects will complete the adjective rating scale during 12 sessions while they are admitted to our inpatient unit. Responses to 16 items are summed (total score=0-64; Higher values=more sedation) to calculate scores on a sedative subscale.
12 times over approximately 1 month inpatient admission
Drug Effect Questionnaire
Time Frame: 12 times over approximately 1 month inpatient admission
Subjects will complete the drug effect questionnaire during 12 sessions while they are admitted to our inpatient unit. The items (total scores=0-100; Higher scores=greater drug effect) on this scale categorize the constellation of drug effects endorsed by subjects.
12 times over approximately 1 month inpatient admission
Heart rate
Time Frame: Daily over approximately four week inpatient admissions
Beats per minute. Measured daily during inpatient admission.
Daily over approximately four week inpatient admissions
Blood pressure
Time Frame: Daily over approximately 1 month inpatient admissions
mmHg. Measured daily during inpatient admission.
Daily over approximately 1 month inpatient admissions
Temperature
Time Frame: Daily over approximately 1 month inpatient admissions
Degrees fahrenheit. Measured daily during inpatient admission.
Daily over approximately 1 month inpatient admissions
Side Effects
Time Frame: Daily over approximately 1 month inpatient admissions
Subjects will complete a side effects questionnaire daily while they reside on the inpatient unit. Side Effects questions will query subjects about common effects of centrally active medications.
Daily over approximately 1 month inpatient admissions
Delay Discounting Task
Time Frame: 12 times over approximately 1 month inpatient admission.
Subjects will complete the delay discounting task during 12 sessions while they are admitted to our inpatient unit. Responses will be used to calculate discounting slope (i.e., K).
12 times over approximately 1 month inpatient admission.
Attentional Bias
Time Frame: 12 times over approximately 1 month inpatient admission.
Subjects will complete attentional bias during 12 sessions while they are admitted to our inpatient unit. Time attending to drug stimuli will be used to evaluate attentional bias.
12 times over approximately 1 month inpatient admission.
Sleep
Time Frame: Daily over approximately 1 month inpatient admissions
Subjects will complete a sleep questionnaire daily while they reside on the inpatient unit.
Daily over approximately 1 month inpatient admissions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 11, 2019

Primary Completion (ACTUAL)

April 30, 2022

Study Completion (ACTUAL)

April 30, 2022

Study Registration Dates

First Submitted

May 2, 2019

First Submitted That Met QC Criteria

May 2, 2019

First Posted (ACTUAL)

May 6, 2019

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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