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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA040644 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This is a single-group, within-subject, double-blind, double-dummy, placebo and active-controlled study evaluated whether the FDA-approved cannabinoid cannabidiol (CBD; Epidiolex) would enhance analgesia, subjective reports, and cognitive performance when compared to the FDA-approved opioid hydromorphone (Dilaudid). This is study 2 is a series of studies.
This was a human laboratory systematic examination of whether adding the FDA-approved cannabinoid cannabidiol (CBD; Epidiolex; oral) to the FDA-approved opioid hydromorphone (Dilaudid; oral) would change the experience of hydromorphone as rated by laboratory measures of pain, subjective reports of drug effects, and cognitive performance. Subjects are healthy individuals with no history of drug use disorder. Study subjects and staff were completed blinded to the study drugs and the class of drugs under investigation and were informed that subjects may receive opioids, stimulants, cannabinoids, benzodiazepines, over the counter medications, and/or placebo. All participants completed all sessions. Sessions lasted up to 8-hours and were conducted at least 7 days apart on an outpatient basis. Primary outcomes were collected from participants prior to dosing and at several hour periods post-dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo+Placebo | Placebo Comparator | Within-subject double-blind, double-dummy administration of placebo + placebo. Order of dose randomized session days 2-5. |
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| Hydromorphone+Placebo | Active Comparator | Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + placebo. Always administered during session 1. |
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| Hydromorphone (oral) 4mg + Cannabidiol 50mg | Experimental | Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 50mg. Order of dose randomized session days 2-5. |
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| Hydromorphone (oral) 4mg + Cannabidiol 100mg | Experimental | Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 100mg. Order of dose randomized session days 2-5. |
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| Hydromorphone (oral) 4mg + Cannabidiol 200mg | Experimental | Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 200mg. Order of dose randomized session days 2-5. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Within-subject test of blinded study medications | Drug | Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Cold Pressor Tolerance | Peak amount of time participant submerged hand in cold pressor (5 degree circulating cold water) laboratory test of pain as a function of double- blinded study medications (range 0 -300). | 8 hour study session |
| Peak Self-report Rating of "Drug Effect" (0-100), as Measured by the Visual Analog Rating Scale | Peak self-report rating of "Drug Effect" on a 0 ("none at all") to 100 ("extremely") visual analog scale as a function of double- blinded study medication, wherein higher values indicate stronger subjectively-experienced drug effects. | 8 hour study session |
| Peak Number Accurate on Circular Lights | Peak number accuracy on the Circular Lights fine motor task as a function of double-blinded study drug administration. Participants were provided 60 seconds to press buttons that are lit in randomized order and displayed automatically on a circular lights wall mounted unit. The primary outcome is the number of lit buttons that were accurately pressed within 60 seconds, which is a metric to assess fine motor impairment. Lower numbers are indicative of greater drug-related impairment. There is no upper limit on the circular lights task. | 8 hour study session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly E Dunn, PhD | Johns Hopkins University | Principal Investigator |
| Claudia Campbell, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University Bayview Medical Campus | Baltimore | Maryland | 21224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40839659 | Derived | Bergeria CL, Mun CJ, Speed TJ, Huhn AS, Wolinsky D, Vandrey R, Campbell CM, Dunn KE. A within-subject, double-blind, placebo-controlled randomized evaluation of the combined effects of cannabidiol and hydromorphone in a human laboratory pain model. Pain. 2025 Feb 28;166(9):e175-e184. doi: 10.1097/j.pain.0000000000003561. |
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This is a within-subject study, and all participants (n=31) completed all study conditions. The same 31 participants moved from one treatment arm to the next.
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| ID | Title | Description |
|---|---|---|
| FG000 | Full Participant Sample | Each participant completed the following five study conditions (arms) in randomized order: Placebo + Placebo condition Hydromorphone (oral) 4mg + placebo condition Hydromorphone (oral) 4mg + Cannabidiol (oral) 50mg condition Hydromorphone (oral) 4mg + Cannabidiol (oral) 100mg condition Hydromorphone (oral) 4mg + Cannabidiol (oral) 200mg condition |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | This is a within group study and same participants went through all treatment arms. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Peak Cold Pressor Tolerance | Peak amount of time participant submerged hand in cold pressor (5 degree circulating cold water) laboratory test of pain as a function of double- blinded study medications (range 0 -300). | Posted | Mean | Standard Error | minutes | 8 hour study session |
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Up to 40 hours
Adverse events were prompted systematically each hour throughout the session and documented according to good clinical practices. Spontaneously reported adverse events were also documented. All reports of symptoms were categorized as discrete events, such that one experience that included more than 1 symptom would be represented by more than 1 event. Events reported here were all rated as definitely or possibly related to study medication, collapsed across severity (mild, moderate, or severe).
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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 | Placebo+Placebo | Within-subject double-blind, double-dummy administration of placebo + placebo. Order of dose randomized session days 2-5. Within-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly Dunn, Professor | Johns Hopkins University School of Medicine | 410-550-2254 | kdunn9@jhmi.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 | Oct 18, 2021 | Oct 31, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 1, 2021 | Oct 31, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D002189 | Marijuana Abuse |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019966 | Substance-Related Disorders |
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Within-subject study
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Study drug administration will be concealed from all study staff and participants to prevent bias in outcomes.
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Hydromorphone+Placebo |
Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + placebo. Always administered during session 1. Within-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition. |
| OG002 | Hydromorphone (Oral) 4mg + Cannabidiol 50mg | Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 50mg. Order of dose randomized session days 2-5. Within-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition. |
| OG003 | Hydromorphone (Oral) 4mg + Cannabidiol 100mg | Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 100mg. Order of dose randomized session days 2-5. Within-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition. |
| OG004 | Hydromorphone (Oral) 4mg + Cannabidiol 200mg | Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 200mg. Order of dose randomized session days 2-5. Within-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition. |
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| Primary | Peak Self-report Rating of "Drug Effect" (0-100), as Measured by the Visual Analog Rating Scale | Peak self-report rating of "Drug Effect" on a 0 ("none at all") to 100 ("extremely") visual analog scale as a function of double- blinded study medication, wherein higher values indicate stronger subjectively-experienced drug effects. | Posted | Mean | Standard Error | units on a scale | 8 hour study session |
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|
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| Primary | Peak Number Accurate on Circular Lights | Peak number accuracy on the Circular Lights fine motor task as a function of double-blinded study drug administration. Participants were provided 60 seconds to press buttons that are lit in randomized order and displayed automatically on a circular lights wall mounted unit. The primary outcome is the number of lit buttons that were accurately pressed within 60 seconds, which is a metric to assess fine motor impairment. Lower numbers are indicative of greater drug-related impairment. There is no upper limit on the circular lights task. | Posted | Mean | Standard Error | correct responses | 8 hour study session |
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| 0 |
| 31 |
| 0 |
| 31 |
| 8 |
| 31 |
| EG001 | Hydromorphone+Placebo | Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + placebo. Always administered during session 1. Within-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition. | 0 | 31 | 0 | 31 | 20 | 31 |
| EG002 | Hydromorphone (Oral) 4mg + Cannabidiol 50mg | Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 50mg. Order of dose randomized session days 2-5. Within-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition. | 0 | 31 | 0 | 31 | 15 | 31 |
| EG003 | Hydromorphone (Oral) 4mg + Cannabidiol 100mg | Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 100mg. Order of dose randomized session days 2-5. Within-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition. | 0 | 31 | 0 | 31 | 22 | 31 |
| EG004 | Hydromorphone (Oral) 4mg + Cannabidiol 200mg | Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 200mg. Order of dose randomized session days 2-5. Within-subject test of blinded study medications: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition. | 0 | 31 | 0 | 31 | 20 | 31 |
| Headache | Blood and lymphatic system disorders | Systematic Assessment |
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| Tachycardia | Cardiac disorders | Systematic Assessment |
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| Abdominal Cramp | Gastrointestinal disorders | Systematic Assessment |
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| Appetite Decrease | Gastrointestinal disorders | Systematic Assessment |
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| Appetite Increase | Gastrointestinal disorders | Systematic Assessment |
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| Dry Mouth | Nervous system disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Clumsy | Nervous system disorders | Systematic Assessment |
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| Confusion | Nervous system disorders | Systematic Assessment |
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| Depression | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Drowsiness | Nervous system disorders | Systematic Assessment |
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| Euphoria | Nervous system disorders | Systematic Assessment |
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| Fatigue | Nervous system disorders | Systematic Assessment |
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| Impaired | Nervous system disorders | Systematic Assessment |
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| Irritability | Nervous system disorders | Systematic Assessment |
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| Light Headed | Nervous system disorders | Systematic Assessment |
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| Nervousness | Nervous system disorders | Systematic Assessment |
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| Tingling | Nervous system disorders | Systematic Assessment |
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| Restlessness | Nervous system disorders | Systematic Assessment |
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| Shaky | Nervous system disorders | Systematic Assessment |
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| Tremor | Nervous system disorders | Systematic Assessment |
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| Yawning | Nervous system disorders | Systematic Assessment |
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| Photosensitivity | Nervous system disorders | Systematic Assessment |
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| Piloerection | Nervous system disorders | Systematic Assessment |
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| Pruitus | Nervous system disorders | Systematic Assessment |
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| Dry Eyes | Nervous system disorders | Systematic Assessment |
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| Frequent Urination | Renal and urinary disorders | Systematic Assessment |
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| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |