- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03937986
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
Status
Completed
Conditions
Intervention / Treatment
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
-
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Kentucky
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Lexington, Kentucky, United States, 40507
- University Of Kentucky
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-
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
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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.
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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.
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Hypnotics and Sedatives
- Anesthetics, Local
- Dopamine Uptake Inhibitors
- Sleep Aids, Pharmaceutical
- Vasoconstrictor Agents
- Orexin Receptor Antagonists
- Suvorexant
- Cocaine
Other Study ID Numbers
- BED IN 39
- R01DA048617 (NIH)
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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