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The goal of this study is to determine the feasibility of a human observational study of orally administered cannabis use among cancer patients.
Tightly controlled experimental laboratory studies (e.g., clinical trials with randomization) using Cannabis products available in state-regulated markets are simply, at this point, not possible owing largely to federal law and the University requirements related to the Controlled Substances Act and Drug Free Schools and Communities Act. Because a traditional clinical trial design is not possible given the current federal status of Cannabis products, this investigator will use a patient-oriented, prospective observational design. Specifically, individuals who have already decided to try Cannabis for their cancer treatment-related symptoms will initiate use of an orally administered product they have selected. A research assistant will provide information on the range of edible cannabis products and basic information about their various cannabinoid profiles, approximate prices, and nearby locations where participants may choose to purchase their product. The participants will then purchase the product and decide how often and how much to use. This approach is consistent with federal law and supported by our preliminary and ongoing studies(1R01AT009541-01, 1R01DA044131-01, CDPHE2902, R01DA039707). Patients will take the product as they see fit, without any frequency or dosing instructions from study staff, for two weeks, at which time they will be scheduled for an acute administration session (Ta1-Tc1) so that we may examine the acute effects of the product. The final follow-up will be one month later via an online survey sent directly to the participant via email.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Cannabis | This is an observational study of individuals who have already decided to try cannabis for their cancer treatment-related symptoms. A research assistant will provide information on the range of edible cannabis products and basic information about their various cannabinoid profiles, approximate prices, and nearby locations where participants may choose to purchase their product. Participants will then initiate use of an orally administered product they have selected and obtained. Participants will take the product as they see fit, without any frequency or dosing instructions from study staff, for two weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Likelihood of Accruing Participants: Feasibility of Enrollment | Enroll a minimum of 30 patients and demonstrate reasonable compliance with study procedures within 54 months of active recruiting. | Approximately 48 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Amount of Interest | Study officials will document how many patients contact the research team regarding their participation in the study | Approximately 48 months |
| Eligibility | Study officials will document how many patients are and are not eligible to participate in the study. |
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
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Male or females, ages 21 and up, with a diagnosis of any solid tumor type who has or is undergoing either curative or palliative treatment
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| Name | Affiliation | Role |
|---|---|---|
| Angela Bryan, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States | ||
| University of Colorado Boulder |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Cannabis | This is an observational study of individuals who have already decided to try cannabis for their cancer treatment-related symptoms. A research assistant will provide information on the range of edible cannabis products and basic information about their various cannabinoid profiles, approximate prices, and nearby locations where participants may choose to purchase their product. Participants will then initiate use of an orally administered product they have selected and obtained. Participants will take the product as they see fit, without any frequency or dosing instructions from study staff, for two weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Cannabis | This is an observational study of individuals who have already decided to try cannabis for their cancer treatment-related symptoms. A research assistant will provide information on the range of edible cannabis products and basic information about their various cannabinoid profiles, approximate prices, and nearby locations where participants may choose to purchase their product. Participants will then initiate use of an orally administered product they have selected and obtained. Participants will take the product as they see fit, without any frequency or dosing instructions from study staff, for two weeks. |
| 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 | Likelihood of Accruing Participants: Feasibility of Enrollment | Enroll a minimum of 30 patients and demonstrate reasonable compliance with study procedures within 54 months of active recruiting. | Number of participants assessed for enrollment | Posted | Count of Participants | Participants | Approximately 48 months |
|
3 months
Participants were asked about the occurrence of adverse events at study visits.
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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 | Oral Cannabis | This is an observational study of individuals who have already decided to try cannabis for their cancer treatment-related symptoms. A research assistant will provide information on the range of edible cannabis products and basic information about their various cannabinoid profiles, approximate prices, and nearby locations where participants may choose to purchase their product. Participants will then initiate use of an orally administered product they have selected and obtained. Participants will take the product as they see fit, without any frequency or dosing instructions from study staff, for two weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased heart rate (over 100 beats per minute) | Cardiac disorders | Systematic Assessment | Heart rate observed to be over 100 beats per minute during a study visit |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Bryan, PhD | University of Colorado Boulder | 3034929549 | Angela.Bryan@Colorado.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 | May 31, 2022 | Dec 11, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Whole blood sample
| Approximately 48 months |
| Enrollment | Study officials will document how many patients actually proceed to enrollment in the study. | Approximately 48 months |
| Completion of Assessments | Study officials will document how many participants complete each assessment (baseline assessment, pre-acute cannabis use assessment, 1 hour post-acute cannabis use, 2 hour post-acute cannabis use, one month follow up assessment). | Baseline to one month follow up, Approximately 48 months |
| Study Completion | Study officials will document how many participants complete the study in its entirety. | Approximately 48 months |
| Boulder |
| Colorado |
| 80309 |
| United States |
| 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 |
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| Region of Enrollment | Number | participants |
|
|
|
| Other Pre-specified | Amount of Interest | Study officials will document how many patients contact the research team regarding their participation in the study | Number of individuals who contacted the research team about participation in the study | Posted | Count of Participants | Participants | No | Approximately 48 months |
|
|
|
| Other Pre-specified | Eligibility | Study officials will document how many patients are and are not eligible to participate in the study. | Number of individuals who contacted the research team about participation in the study | Posted | Count of Participants | Participants | Approximately 48 months |
|
|
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| Other Pre-specified | Enrollment | Study officials will document how many patients actually proceed to enrollment in the study. | Number of individuals found eligible after pre-screening | Posted | Count of Participants | Participants | Approximately 48 months |
|
|
|
| Other Pre-specified | Completion of Assessments | Study officials will document how many participants complete each assessment (baseline assessment, pre-acute cannabis use assessment, 1 hour post-acute cannabis use, 2 hour post-acute cannabis use, one month follow up assessment). | Number of participants enrolled | Posted | Count of Participants | Participants | Baseline to one month follow up, Approximately 48 months |
|
|
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| Other Pre-specified | Study Completion | Study officials will document how many participants complete the study in its entirety. | Number of participants enrolled | Posted | Count of Participants | Participants | Approximately 48 months |
|
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| 0 |
| 27 |
| 0 |
| 27 |
| 1 |
| 27 |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
|
| Completed 2 hour post-acute cannabis use assessment |
|
| Completed one month follow up assessment |
|