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Suvorexant and Cocaine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937986
Recruitment Status : Suspended (COVID-19)
First Posted : May 6, 2019
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
William Stoops, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Cocaine Use Disorder Drug: Suvorexant Drug: Cocaine Drug: Placebo oral capsule Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Influence of Orexin Antagonism on Motivation for Cocaine
Actual Study Start Date : July 11, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


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

Drug: Placebo oral capsule
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.
Drug: Suvorexant
The pharmacodynamic effects of suvorexant maintenance will be determined.

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

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.
Drug: Suvorexant
The pharmacodynamic effects of suvorexant maintenance will be determined.

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

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.
Drug: Suvorexant
The pharmacodynamic effects of suvorexant maintenance will be determined.

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




Primary Outcome Measures :
  1. Reinforcing Effects of Cocaine Following Placebo Maintenance. [ Time Frame: Following at least 3 days of maintenance on placebo during inpatient admission ]
    Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.

  2. Reinforcing Effects of Cocaine Following Suvorexant Dose 1 Maintenance. [ Time Frame: Following at least 3 days of maintenance on suvorexant dose 1 during inpatient admission ]
    Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.

  3. Reinforcing Effects of Cocaine Following Suvorexant Dose 2 Maintenance. [ Time Frame: Following at least 3 days of maintenance on suvorexant dose 2 during inpatient admission ]
    Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.

  4. Reinforcing Effects of Cocaine Following Suvorexant Dose 3 Maintenance. [ Time Frame: Following at least 3 days of maintenance on suvorexant dose 3 during inpatient admission ]
    Number of cocaine doses earned by subjects on a progressive ratio schedule of reinforcement.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Heart rate [ Time Frame: Daily over approximately four week inpatient admissions ]
    Beats per minute. Measured daily during inpatient admission.

  5. Blood pressure [ Time Frame: Daily over approximately 1 month inpatient admissions ]
    mmHg. Measured daily during inpatient admission.

  6. Temperature [ Time Frame: Daily over approximately 1 month inpatient admissions ]
    Degrees fahrenheit. Measured daily during inpatient admission.

  7. 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.

  8. 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).

  9. 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.

  10. Sleep [ Time Frame: Daily over approximately 1 month inpatient admissions ]
    Subjects will complete a sleep questionnaire daily while they reside on the inpatient unit.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937986


Locations
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United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40507
Sponsors and Collaborators
William Stoops
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: William W Stoops, PhD University of Kentucky
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Responsible Party: William Stoops, Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT03937986    
Other Study ID Numbers: BED IN 39
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cocaine
Suvorexant
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Orexin Receptor Antagonists