Cannabis Use in Cancer Patients

  • STATUS
    Recruiting
  • End date
    Dec 20, 2022
  • participants needed
    30
  • sponsor
    University of Colorado, Denver
Updated on 13 October 2021
cancer
solid tumor

Summary

The goal of this study is to determine the feasibility of a human observational study of orally administered cannabis use among cancer patients.

Description

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 their session in our mobile pharmacology and phlebotomy lab (Ta1-Tc1) so that we may examine the acute effects of the product. The Mobile Lab session will take place at a location of their choosing up to 90 minutes drive-time away from the CUChange Lab. The final follow-up will be one month later via an online survey sent directly to the participant via email.

Details
Condition Non Small Cell Lung Cancer Metastatic, Solid Tumor, Adult, Solid Tumor, Adult, Solid Tumor, Adult, Solid Tumor, Adult, Solid Tumor, Adult, Solid Tumor, Adult, Solid Tumor, Adult, Solid Tumor, Adult, Solid Tumor, Adult
Clinical Study IdentifierNCT03617692
SponsorUniversity of Colorado, Denver
Last Modified on13 October 2021

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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