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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA048617 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suvorexant | Drug | The pharmacodynamic effects of suvorexant maintenance will be determined. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reinforcing Effects of Cocaine | Number of Times Subjects Choose Cocaine (Maximum of 10 Choices) Over Money | 12 times over approximately 1 month inpatient admission. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William W Stoops, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40507 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Included in Analysis | This study used a within subjects design (i.e., all subjects were to receive all oral suvorexant maintenance conditions [0, 5, 10 and 20 mg] and intravenous cocaine doses [0, 10 and 30 mg/70 kg]). Seven subjects completed the full study. An eighth was enrolled but discharged at the outset of the COVID-19 pandemic. Data from completed sessions for that subject are included here. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Included in Analysis | This study used a within subjects design (i.e., all subjects were to receive all oral suvorexant maintenance conditions [0, 5, 10 and 20 mg] and intravenous cocaine doses [0, 10 and 30 mg/70 kg]). Seven subjects completed the full study. An eighth was enrolled but discharged at the outset of the COVID-19 pandemic. Data from completed sessions for that subject are included here. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reinforcing Effects of Cocaine | Number of Times Subjects Choose Cocaine (Maximum of 10 Choices) Over Money | Posted | Mean | Standard Error | Number of Cocaine Choices | 12 times over approximately 1 month inpatient admission. |
|
32 months
Definitions for adverse events/serious adverse events follow clinicaltrials.gov guidelines.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects Included in Analysis | This study used a within subjects design (i.e., all subjects were to receive all oral suvorexant maintenance conditions [0, 5, 10 and 20 mg] and intravenous cocaine doses [0, 10 and 30 mg/70 kg]). Seven subjects completed the full study. An eighth was enrolled but discharged at the outset of the COVID-19 pandemic. Data from completed sessions for that subject are included here. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated Heart Rate | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William W. Stoops | University of Kentucky | 859-257-5388 | william.stoops@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 26, 2019 | Jan 11, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C551624 | suvorexant |
| D003042 | Cocaine |
| ID | Term |
|---|---|
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
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| Cocaine | Drug | The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and suvorexant. |
|
| Placebo oral capsule | Drug | The pharmacodynamic effects of placebo will be determined. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 | Dose Condition 4 | 0 mg/70 kg IV Cocaine and 5 mg/day Oral Suvorexant |
| OG004 | Dose Condition 5 | 10 mg/70 kg IV Cocaine and 5 mg/day Oral Suvorexant |
| OG005 | Dose Condition 6 | 30 mg/70 kg IV Cocaine and 5 mg/day Oral Suvorexant |
| OG006 | Dose Condition 7 | 0 mg/70 kg IV Cocaine and 10 mg/day Oral Suvorexant |
| OG007 | Dose Condition 8 | 10 mg/70 kg IV Cocaine and 10 mg/day Oral Suvorexant |
| OG008 | Dose Condition 9 | 30 mg/70 kg IV Cocaine and 10 mg/day Oral Suvorexant |
| OG009 | Dose Condition 10 | 0 mg/70 kg IV Cocaine and 20 mg/day Oral Suvorexant |
| OG010 | Dose Condition 11 | 10 mg/70 kg IV Cocaine and 20 mg/day Oral Suvorexant |
| OG011 | Dose Condition 12 | 30 mg/70 kg IV Cocaine and 20 mg/day Oral Suvorexant |
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 8 |
| 8 |
| Elevated Blood Pressure | Cardiac disorders | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Bruising | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Burning Sensation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| IV Needle Infiltration | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Shoulder Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hand Swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Arm Soreness | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Saline Taste from IV Flush | Gastrointestinal disorders | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
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| Increased Dream Activity | Nervous system disorders | Systematic Assessment |
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| Increased Sleep | Nervous system disorders | Systematic Assessment |
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| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |