Cannabis Use in Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03617692|
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : February 6, 2019
|Condition or disease|
|Non-small Cell Lung Cancer Metastatic|
The goal of this study is to determine the feasibility of a human observational study of orally administered cannabis use among lung cancer patients. Because a traditional clinical trial design is not possible given the current federal status of cannabis products, this study will use a patient-oriented, prospective observational design.
Specifically, individuals who have already decided to try cannabis for cancer treatment-related symptoms will initiate use of an orally administered product they have selected. Study participants will complete one baseline study visit at a laboratory at the University of Boulder followed by a two week period of ad libitum use. At the baseline visit, investigators will collect a blood sample, administer some brief thinking and memory tasks, and ask participants to complete surveys about sleep, health, and mood. Following the baseline visit, study participants would independently purchase the product of their choice and use the product as much as they wish to.
After two weeks of ad libitum cannabis use, researchers will travel in a mobile pharmacology laboratory to the study participant's home for the second study visit. This visit takes place inside the mobile lab, and includes the same measures as the baseline visit, both before and after use of the participant's cannabis product.
Finally, participants will complete online surveys sent by email one month after their two week appointment.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Effects of Cannabis Use in Cancer Patients: A Feasibility Study|
|Actual Study Start Date :||December 4, 2018|
|Estimated Primary Completion Date :||January 20, 2020|
|Estimated Study Completion Date :||January 20, 2021|
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.
- Likelihood of Accruing Participants: Feasibility of Enrollment [ Time Frame: Six months ]Enroll a minimum of 30 patients and demonstrate reasonable compliance with study procedures within six months of active recruiting.
- Amount of Interest [ Time Frame: Six months ]Study officials will document how many patients contact the research team regarding their participation in the study
- Eligibility [ Time Frame: Six months ]Study officials will document how many patients are and are not eligible to participate in the study.
- Enrollment [ Time Frame: Six months ]Study officials will document how many patients actually proceed to enrollment in the study.
- Completion of Assessments [ Time Frame: Baseline to one month follow up, in a six month time frame ]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).
- Study Completion [ Time Frame: Six months ]Study officials will document how many participants complete the study in its entirety.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03617692
|Contact: Angela Bryan, PhDfirstname.lastname@example.org|
|United States, Colorado|
|University of Colorado Hospital||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Angela Bryan, PhD 303-588-3335 email@example.com|
|Principal Investigator: Angela Bryan, PhD|
|University of Colorado Boulder||Not yet recruiting|
|Boulder, Colorado, United States, 80309|
|Contact: Angela Bryan, PhD 303-492-8264 firstname.lastname@example.org|
|Principal Investigator: Angela Bryan, PhD|
|Principal Investigator:||Angela Bryan, PhD||University of Colorado, Denver|