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| Name | Class |
|---|---|
| Alkermes, Inc. | INDUSTRY |
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Chronic pain is a significant public health concern in the U.S., for which prescription opioids have historically been the standard treatment. This has resulted in striking rates of opioid use disorders and fatal overdoses. Identifying non-opioid medications for the management of chronic pain with minimal abuse liability is a public health necessity, and cannabinoids are a promising drug class for this purpose. More than 80% of medicinal cannabis users report pain as their primary medical indication. These patients tend to seek products that are low in delta-9-tetrahydrocannabinol (THC; the primary psychoactive, and thus intoxicating, component of cannabis), and high in cannabidiol (CBD), a cannabinoid that purportedly has therapeutic benefit for pain but does not produce intoxicating effects. However, there are few well-controlled human laboratory studies assessing the efficacy of high-CBD cannabis for pain in the context of abuse, and even less is known regarding the effects of daily repeated use of cannabis on pain and its relationship to abuse liability.
The proposed randomized, within-subjects, placebo-controlled 16-day crossover inpatient human laboratory pilot study (N = 16 healthy cannabis users; 8 men, 8 women) will address important gaps in our understanding of the potential therapeutic utility of cannabis for pain: 1) If repeated cannabis use can result in hyperalgesia; 2) If tolerance to the analgesic and abuse-related effects of cannabis develops and is reversible. Two distinct modalities of experimental pain will be assessed: The Cold Pressor Test (CPT) and Quantitative Sensory Testing Thermal Temporal Summation (QST-TTS), and participants will smoke cannabis 3x/day. Throughout the study, experimental pain and abuse-related effects will be assessed, as will sleep and subjective mood assessments.
This protocol is currently suspended due to the NYSPI human subjects research pause and results cannot currently be analyzed and posted. Upon un-suspension, we will analyze the data and post results immediately.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose A: Standardization Phase | Experimental | On the first full inpatient day (Day 1), participants will smoke one specified strength (Dose A; 75% of active cannabis cigarette, 2.98% THC, 4.91% CBD) of cannabis. |
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| Dose B: Placebo Phase | Placebo Comparator | Days 2-8 comprises the Placebo phase, in which a second strength (Dose B; 75% of one placebo cannabis cigarette, <0.01% THC, CBD) of cannabis will be administered 3x/day. |
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| Dose A: Active Phase | Experimental | Days 9-15 comprise the Active Phase, cannabis Dose A (75% of one active cannabis cigarette, 2.98% THC, 4.91% CBD) will be administered once again, 3x/day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Cannabis | Drug | 2.98% THC:4.91% CBD cannabis. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Cold Pressor Test (CPT) Latency | The CPT apparatus consists of two refrigerated circulators, filled with warm (36.5-37.5°C). participants will complete the CPT 30 minutes before the 1000h cannabis administration (baseline), and 15, 30, 45, 60, and 90 minutes post-cannabis administration. and cold (3.5 - 4.5°C) water. Participants will insert their non-dominant hand into the warm water and remove it after 3 minutes; skin temperature of the thumb pad will be measured. Participants will then insert their hand in the cold water and will be instructed to report when they first experience pain (pain threshold) and remove their hand when the cold water can no longer be tolerated (pain tolerance). Maximum immersion time will be 3 minutes. Data points reported here represent Percent Change in Pain Tolerance from Day 1 (first timepoint, 15 minutes post-cannabis [2.98% THC / 4.91% CBD]) across study days (Day 2, 5, 8, 9, 12, and 15). Other timepoints are not reported. | Up to 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cannabis Rating Form (CRF) Ratings | Participants rate the "high" experienced as a result of cannabis administration on a 100mm visual analog scale. Data points represent Percent Change from Day 1 (first timepoint, 15 minutes post-cannabis [2.98% THC / 4.91% CBD]) across study days (Day 2, 5, 8, 9, 12, and 15) Repeats at days 1, 2, 5, 8, 9, 12, and 15. | Up to 15 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
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There were no significant events in the study post-enrollment and/or prior to participants beginning study procedures.
Participants were recruited between June 2021 and June 2023. Eligible participants were recruited from the New York, NY area and occurred through advertisements in local newspapers, online through Craigslist, RecruitMe, and by word of mouth.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose A - Dose B - Dose A | On the first full inpatient day (Day 1), participants smoked one specified strength (Dose A; active cannabis, 2.98% THC, 4.91% CBD) of cannabis. Days 2-8 comprised Phase 1, in which a second strength (Dose B; placebo cannabis, <0.01% THC, CBD) of cannabis was administered 3x/day. The next 7 days (Day 9-15) comprised Phase 2, in which cannabis Dose A (active cannabis, 2.98% THC, 4.91% CBD) was administered again, at the same 3 daily time points. All participants underwent this same allocation. Cannabis: Investigates two strengths of cannabis. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose A - Dose B - Dose A | On the first full inpatient day (Day 1), participants smoked one specified strength (Dose A; active cannabis, 2.98% THC, 4.91% CBD) of cannabis. Days 2-8 comprised Phase 1, in which a second strength (Dose B; placebo cannabis, <0.01% THC, CBD) of cannabis was administered 3x/day. The next 7 days (Day 9-15) comprised Phase 2, in which cannabis Dose A (active cannabis, 2.98% THC, 4.91% CBD) was administered again, at the same 3 daily time points. All participants underwent this same allocation. Cannabis: Investigates two strengths of cannabis. |
| 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, Categorical | Count of Participants |
| 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 | Change in Cold Pressor Test (CPT) Latency | The CPT apparatus consists of two refrigerated circulators, filled with warm (36.5-37.5°C). participants will complete the CPT 30 minutes before the 1000h cannabis administration (baseline), and 15, 30, 45, 60, and 90 minutes post-cannabis administration. and cold (3.5 - 4.5°C) water. Participants will insert their non-dominant hand into the warm water and remove it after 3 minutes; skin temperature of the thumb pad will be measured. Participants will then insert their hand in the cold water and will be instructed to report when they first experience pain (pain threshold) and remove their hand when the cold water can no longer be tolerated (pain tolerance). Maximum immersion time will be 3 minutes. Data points reported here represent Percent Change in Pain Tolerance from Day 1 (first timepoint, 15 minutes post-cannabis [2.98% THC / 4.91% CBD]) across study days (Day 2, 5, 8, 9, 12, and 15). Other timepoints are not reported. | Data represents CPT Pain Tolerance for study completers (n=5) across the 15-day testing period. This is a repeated measures design, meaning that all 5 participants contributed to each timepoint. | Posted | Mean | Standard Error | percent change from Day 1 baseline | Up to 15 days |
Information on adverse events was collected continuously for the duration of study participation for each participant, which was approximately 1 month (screening through study completion). All participants received the same order of drug administration and as such, are reported under one condition.
Drug effects as a result of cannabis administration were expected, and not considered adverse events at the time.
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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 | All Participants | Data on potential adverse events were collected throughout the duration of the study (06/2021 - 06/2023). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| High blood pressure | Cardiac disorders | Systematic Assessment | Pre-active cannabis (before Dose A) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caroline A. Arout, Ph.D. | New York State Psychiatric Institute | 646-774-6167 | caroline.arout@nyspi.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 10, 2025 | Apr 14, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 14, 2025 | Apr 14, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| D010146 | Pain |
| D006930 | Hyperalgesia |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
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This study comprises a 16-day inpatient stay. On the first full inpatient day (Day 1), participants will smoke one specified strength (Dose A; active cannabis, 2.98% THC and 4.91% CBD) of cannabis. Days 2-8 will comprise Phase 1, in which a second strength (Dose B; placebo cannabis, <0.01% THC,CBD) of cannabis will be administered 3x/day. The next 7 days (Day 9-15) will be Phase 2, in which cannabis Dose A (active cannabis, 2.98% THC and 4.91% CBD) will be administered once again, at the same 3 daily time points.
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Participants are blind to what cannabis dose they are receiving on which day, though it is the same for all:
Day 1: active cannabis (2.98% THC and 4.91% CBD) Day 2-8: placebo cannabis (<0.01% THC, CBD) Day 9-15: active cannabis (2.98% THC and 4.91% CBD)
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| Placebo Cannabis | Drug | <0.01% THC:CBD cannabis. |
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| Participants |
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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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| ID | Title | Description |
|---|---|---|
| OG000 | CPT Pain Tolerance: Day 2 | The CPT apparatus consists of two refrigerated circulators, filled with warm (36.5-37.5°C). participants will complete the CPT 30 minutes before the 1000h cannabis administration (baseline), and 0, 15, 30, 45, 60, and 90 minutes post-cannabis administration. and cold (3.5 - 4.5°C) water. Participants will insert their non-dominant hand into the warm water and remove it after 3 minutes; skin temperature of the thumb pad will be measured. Participants will then insert their hand in the cold water and will be instructed to report when they first experience pain (pain threshold) and remove their hand when the cold water can no longer be tolerated (pain tolerance). Maximum immersion time will be 3 minutes. Data points represent Percent Change in Pain Tolerance from Day 1 (first timepoint, 15 minutes post-cannabis [2.98% THC / 4.91% CBD]) across study days (Day 2, 5, 8, 9, 12, and 15). |
| OG001 | CPT Pain Tolerance: Day 5 | The CPT apparatus consists of two refrigerated circulators, filled with warm (36.5-37.5°C). participants will complete the CPT 30 minutes before the 1000h cannabis administration (baseline), and 0, 15, 30, 45, 60, and 90 minutes post-cannabis administration. and cold (3.5 - 4.5°C) water. Participants will insert their non-dominant hand into the warm water and remove it after 3 minutes; skin temperature of the thumb pad will be measured. Participants will then insert their hand in the cold water and will be instructed to report when they first experience pain (pain threshold) and remove their hand when the cold water can no longer be tolerated (pain tolerance). Maximum immersion time will be 3 minutes. Data points represent Percent Change in Pain Tolerance from Day 1 (first timepoint, 15 minutes post-cannabis [2.98% THC / 4.91% CBD]) across study days (Day 2, 5, 8, 9, 12, and 15). |
| OG002 | CPT Pain Tolerance: Day 8 | The CPT apparatus consists of two refrigerated circulators, filled with warm (36.5-37.5°C). participants will complete the CPT 30 minutes before the 1000h cannabis administration (baseline), and 0, 15, 30, 45, 60, and 90 minutes post-cannabis administration. and cold (3.5 - 4.5°C) water. Participants will insert their non-dominant hand into the warm water and remove it after 3 minutes; skin temperature of the thumb pad will be measured. Participants will then insert their hand in the cold water and will be instructed to report when they first experience pain (pain threshold) and remove their hand when the cold water can no longer be tolerated (pain tolerance). Maximum immersion time will be 3 minutes. Data points represent Percent Change in Pain Tolerance from Day 1 (first timepoint, 15 minutes post-cannabis [2.98% THC / 4.91% CBD]) across study days (Day 2, 5, 8, 9, 12, and 15). |
| OG003 | CPT Pain Tolerance: Day 9 | The CPT apparatus consists of two refrigerated circulators, filled with warm (36.5-37.5°C). participants will complete the CPT 30 minutes before the 1000h cannabis administration (baseline), and 0, 15, 30, 45, 60, and 90 minutes post-cannabis administration. and cold (3.5 - 4.5°C) water. Participants will insert their non-dominant hand into the warm water and remove it after 3 minutes; skin temperature of the thumb pad will be measured. Participants will then insert their hand in the cold water and will be instructed to report when they first experience pain (pain threshold) and remove their hand when the cold water can no longer be tolerated (pain tolerance). Maximum immersion time will be 3 minutes. Data points represent Percent Change in Pain Tolerance from Day 1 (first timepoint, 15 minutes post-cannabis [2.98% THC / 4.91% CBD]) across study days (Day 2, 5, 8, 9, 12, and 15). |
| OG004 | CPT Pain Tolerance: Day 12 | The CPT apparatus consists of two refrigerated circulators, filled with warm (36.5-37.5°C). participants will complete the CPT 30 minutes before the 1000h cannabis administration (baseline), and 0, 15, 30, 45, 60, and 90 minutes post-cannabis administration. and cold (3.5 - 4.5°C) water. Participants will insert their non-dominant hand into the warm water and remove it after 3 minutes; skin temperature of the thumb pad will be measured. Participants will then insert their hand in the cold water and will be instructed to report when they first experience pain (pain threshold) and remove their hand when the cold water can no longer be tolerated (pain tolerance). Maximum immersion time will be 3 minutes. Data points represent Percent Change in Pain Tolerance from Day 1 (first timepoint, 15 minutes post-cannabis [2.98% THC / 4.91% CBD]) across study days (Day 2, 5, 8, 9, 12, and 15). |
| OG005 | CPT Pain Tolerance: Day 15 | The CPT apparatus consists of two refrigerated circulators, filled with warm (36.5-37.5°C). participants will complete the CPT 30 minutes before the 1000h cannabis administration (baseline), and 0, 15, 30, 45, 60, and 90 minutes post-cannabis administration. and cold (3.5 - 4.5°C) water. Participants will insert their non-dominant hand into the warm water and remove it after 3 minutes; skin temperature of the thumb pad will be measured. Participants will then insert their hand in the cold water and will be instructed to report when they first experience pain (pain threshold) and remove their hand when the cold water can no longer be tolerated (pain tolerance). Maximum immersion time will be 3 minutes. Data points represent Percent Change in Pain Tolerance from Day 1 (first timepoint, 15 minutes post-cannabis [2.98% THC / 4.91% CBD]) across study days (Day 2, 5, 8, 9, 12, and 15). |
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| Secondary | Change in Cannabis Rating Form (CRF) Ratings | Participants rate the "high" experienced as a result of cannabis administration on a 100mm visual analog scale. Data points represent Percent Change from Day 1 (first timepoint, 15 minutes post-cannabis [2.98% THC / 4.91% CBD]) across study days (Day 2, 5, 8, 9, 12, and 15) Repeats at days 1, 2, 5, 8, 9, 12, and 15. | Data represents mean ratings for "high" on a 0-100mm visual analog scale, where 0 represents no "high" and 100 represents the maximum amount of "high" for study completers (n=5) across the 15-day testing period. This is a repeated measures design, meaning that all 5 participants contributed to each timepoint. | Posted | Mean | Standard Error | score on a scale | Up to 15 days |
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| 0 |
| 10 |
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| 10 |
| 4 |
| 10 |
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| Acid reflux | Gastrointestinal disorders | Non-systematic Assessment | During placebo cannabis administration (Dose B). |
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| High blood pressure | Cardiac disorders | Systematic Assessment | During active cannabis administration (Dose A) |
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| High blood pressure | Cardiac disorders | Systematic Assessment | During placebo cannabis administration (Dose B). |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009422 | Nervous System Diseases |