Cannabis Use in Cancer Patients

Effects of Cannabis Use in Cancer Patients: A Feasibility Study

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

Study Overview

• Status: Completed
• Conditions: Solid Tumor, Adult

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.

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital
    • Boulder, Colorado, United States, 80309
      • University of Colorado Boulder

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision to sign and date the consent form.
2. Stated willingness to comply with all study procedures and be available for the duration of the study.
3. Be a female or male aged at least 21 years.
4. Have a diagnosis of any solid tumor type who has or is undergoing either curative or palliative treatment
5. Have intent or interest to use cannabis to treat their symptoms.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Report of other non-prescription drug use, such as cocaine, heroin, methamphetamine in the past 60 days
2. Actively seeking or in treatment for any substance use disorder
3. Acute illness other than cancer that could affect cognition or compliance per the decision of the study M.D.
4. Premenopausal females who are pregnant or trying to become pregnant. Note that pregnancy testing will not be required.
5. A Telephone Interview for Cognitive Status (TICS) score indicating moderate or severe cognitive impairment at screening

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Angela Bryan, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2018
• Primary Completion (Actual): December 12, 2022
• Study Completion (Actual): December 12, 2022

Study Registration Dates

• First Submitted: July 23, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Observational Study; Cannabis; Tumors
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse
• Other Study ID Numbers: 18-0836.cc

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No