NCT03617692

Cannabis Use in Cancer Patients

Effects of Cannabis Use in Cancer Patients: A Feasibility Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 27 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 21 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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 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.

Conditions

• Solid Tumor, Adult

Timeline

• Start date: 2018-12-04
• Primary completion: 2022-12-12
• Completion: 2022-12-12
• First posted: 2018-08-06
• Last updated: 2024-06-11
• Results posted: 2024-06-11

Locations

2 sites across 1 country: United States