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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA042751 | 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 research is being done to evaluate whether combining medications that are FDA approved, but have not yet been approved for combination treatment, can be effective in reducing pain.
This study will evaluate whether a combination of pharmacotherapies can effectively alleviate pain. Subjects will complete two screening sessions before completing four study sessions that will occur once weekly. Participants will receive double blind doses of study medications the morning of each experimental session day and will undergo standardized pain testing, physical functioning assessment, blood draws, ratings of drug effects and cognitive testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Blinded study medication. This is a within-subject study so all session procedures will be identical. The specific medications administered that study day will be the only change each session. Study days will last approximately 8 hours and will be conducted on an outpatient basis. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit. |
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| Arm 2 | Experimental | Blinded study medication. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit. |
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| Arm 3 | Experimental | Blinded study medication. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit. |
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| Arm 4 | Experimental | Blinded study medication. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blinded study medication | Drug | Blinded study medication: This is a double-blind within-subject Phase II trial. Study medications will remain blinded. Participants may receive a dose of medication from one or more of the following categories: prescription stimulants, prescription benzodiazepines, prescription opioids, prescription cannabinoids, over-the-counter medications or placebo (sugar pill). All subjects will serve as their own control. Study medication administration will be randomized within each participant. |
| Measure | Description | Time Frame |
|---|---|---|
| Largest Change From Baseline on Clinical Pain Rating | The study will measure whether blinded study medications change clinical pain ratings (0-100 pain rating scale). Higher score indicates worse outcome. Biggest difference from baseline over the entire session is reported. | 8 hour study session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia M Campbell, Ph.D. | Johns Hopkins University | Principal Investigator |
| Kelly E Dunn, Ph.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins | Baltimore | Maryland | 21224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41481837 | Derived | Hamilton KR, Mun CJ, Sadik E, Bergeria CL, Huhn AS, Speed TJ, Vandrey R, Dunn KE, Campbell CM. Evaluating the Acute Effects of the Cannabinoid Dronabinol and the Opioid Hydromorphone Alone and in Combination: A Double-blind, Randomized, Placebo-controlled Trial in Knee Osteoarthritis. Anesthesiology. 2026 May 1;144(5):1187-1198. doi: 10.1097/ALN.0000000000005925. Epub 2025 Dec 31. |
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Experimental Session 1 is a safety session and completed first. The remaining sessions were completed in triple blinded randomized order.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hydromorphone+Placebo | Within-subject double-blind, double-dummy administration of hydromorphone (oral) + placebo. Always administered during session 1. This is a within-subject study so all session procedures will be identical. The specific medications administered that study day will be the only change each session. Study days will last approximately 8 hours and will be conducted on an outpatient basis. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit. This is a double-blind within-subject Phase II trial. Study medications will remain blinded. All subjects will serve as their own control. Study medication administration will be randomized within each participant. |
| FG001 | Placebo+Placebo | Within-subject double-blind, double-dummy administration of placebo + placebo. Order of dose randomized session days 2-4. This is a within-subject study so all session procedures will be identical. The specific medications administered that study day will be the only change each session. Study days will last approximately 8 hours and will be conducted on an outpatient basis. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit. This is a double-blind within-subject Phase II trial. Study medications will remain blinded. All subjects will serve as their own control. Study medication administration will be randomized within each participant. |
| FG002 | Dronabinol + Placebo | Within-subject double-blind, double-dummy administration of dronabinol + placebo. Order of dose randomized session days 2-4. This is a within-subject study so all session procedures will be identical. The specific medications administered that study day will be the only change each session. Study days will last approximately 8 hours and will be conducted on an outpatient basis. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit. This is a double-blind within-subject Phase II trial. Study medications will remain blinded. All subjects will serve as their own control. Study medication administration will be randomized within each participant. |
| FG003 | Hydromorphone + Dronabinol | Within-subject double-blind, double-dummy administration of hydromorphone + dronabinol. Order of dose randomized session days 2-4. This is a within-subject study so all session procedures will be identical. The specific medications administered that study day will be the only change each session. Study days will last approximately 8 hours and will be conducted on an outpatient basis. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit. This is a double-blind within-subject Phase II trial. Study medications will remain blinded. All subjects will serve as their own control. Study medication administration will be randomized within each participant. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Experimental Session 1 |
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| Experimental Sessions 2-4 |
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| Experimental Sessions 2-4 |
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| Experimental Sessions 2-4 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | This is a within-subject study so all session procedures will be identical. The specific medications administered that study day will be the only change each session. Study days will last approximately 8 hours and will be conducted on an outpatient basis. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit. This is a double-blind within-subject Phase II trial. Study medications will remain blinded. All subjects will serve as their own control. Study medication administration will be randomized within each participant. |
| 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 | Largest Change From Baseline on Clinical Pain Rating | The study will measure whether blinded study medications change clinical pain ratings (0-100 pain rating scale). Higher score indicates worse outcome. Biggest difference from baseline over the entire session is reported. | Posted | Mean | Standard Deviation | score on a scale | 8 hour study session |
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Up to 40 hours
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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 | Placebo + Placebo. This is a within-subject study so all session procedures will be identical. The specific medications administered that study day will be the only change each session. Study days will last approximately 8 hours and will be conducted on an outpatient basis. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit. Blinded study medication: Placebo + Placebo. This is a double-blind within-subject Phase II trial. Study medications will remain blinded. All subjects will serve as their own control. Study medication administration will be randomized within each participant. |
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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 | |
|---|---|---|---|---|
| Claudia Campbell | Johns Hopkins University | 4105507989 | ccampb41@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 | Aug 17, 2020 | Nov 12, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000697 | Central Nervous System Stimulants |
| D001569 | Benzodiazepines |
| D000701 | Analgesics, Opioid |
| D002186 | Cannabinoids |
| D004366 | Nonprescription Drugs |
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
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This study will include 4 sessions. Participants will be randomly assigned to the order in which they receive one drug (or combination of drugs) per session at each study visit.
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Within-subjects design. Two pills will be administered at each study visit. Participants and study staff will be blind to the drug(s) administered.
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | 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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| OG001 | Hydromorphone + Placebo | Hydromorphone + Placebo. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit. Blinded study medication: Hydromorphone + Placebo. This is a double-blind within-subject Phase II trial. Study medications will remain blinded. All subjects will serve as their own control. Study medication administration will be randomized within each participant. |
| OG002 | Dronabinol + Placebo | Dronabinol + Placebo. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit. Blinded study medication: Dronabinol + Placebo. This is a double-blind within-subject Phase II trial. Study medications will remain blinded. All subjects will serve as their own control. Study medication administration will be randomized within each participant. |
| OG003 | Hydromorphone + Dronabinol | Hydromorphone + Dronabinol. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit. Blinded study medication: Hydromorphone + Dronabinol. This is a double-blind within-subject Phase II trial. Study medications will remain blinded. All subjects will serve as their own control. Study medication administration will be randomized within each participant. |
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|
|
| 0 |
| 58 |
| 0 |
| 58 |
| 15 |
| 58 |
| EG001 | Hydromorphone + Placebo | Hydromorphone + Placebo. This is a within-subject study so all session procedures will be identical. The specific medications administered that study day will be the only change each session. Study days will last approximately 8 hours and will be conducted on an outpatient basis. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit. Blinded study medication: Hydromorphone + Placebo. This is a double-blind within-subject Phase II trial. Study medications will remain blinded. All subjects will serve as their own control. Study medication administration will be randomized within each participant. | 0 | 58 | 0 | 58 | 10 | 58 |
| EG002 | Dronabinol + Placebo | Dronabinol + Placebo. This is a within-subject study so all session procedures will be identical. The specific medications administered that study day will be the only change each session. Study days will last approximately 8 hours and will be conducted on an outpatient basis. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit. Blinded study medication: Dronabinol + Placebo. This is a double-blind within-subject Phase II trial. Study medications will remain blinded. All subjects will serve as their own control. Study medication administration will be randomized within each participant. | 0 | 58 | 0 | 58 | 13 | 58 |
| EG003 | Hydromorphone + Dronabinol | Hydromorphone + Dronabinol. This is a within-subject study so all session procedures will be identical. The specific medications administered that study day will be the only change each session. Study days will last approximately 8 hours and will be conducted on an outpatient basis. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit. Blinded study medication: Hydromorphone + Dronabinol. This is a double-blind within-subject Phase II trial. Study medications will remain blinded. All subjects will serve as their own control. Study medication administration will be randomized within each participant. | 0 | 58 | 0 | 58 | 21 | 58 |
| Headache | Blood and lymphatic system disorders | Systematic Assessment |
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| Hypotensive | Cardiac disorders | Systematic Assessment |
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| Abdominal Cramps | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal 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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| Blurred Vision | Nervous system 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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| Coughing | Nervous system disorders | Systematic Assessment |
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| Diaphoresis | Nervous system disorders | Systematic Assessment |
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| Difficulty Concentrating | 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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| Dry Mouth | Nervous system disorders | Systematic Assessment |
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| Impaired | Nervous system disorders | Systematic Assessment |
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| Itchy Eyes | Nervous system disorders | Systematic Assessment |
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| Light Headed | Nervous system disorders | Systematic Assessment |
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| Numb | Nervous system disorders | Systematic Assessment |
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| Restless | Nervous system disorders | Systematic Assessment |
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| Tremor | Nervous system disorders | Systematic Assessment |
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| Paranoia | Psychiatric disorders | Systematic Assessment |
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| Incontenance | Renal and urinary disorders | Systematic Assessment |
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| D012216 |
| Rheumatic Diseases |
| D045506 | Therapeutic Uses |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |