Clinical trial NCT03617692: Cannabis Use in Cancer Patients
Official title: Effects of Cannabis Use in Cancer Patients: A Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Solid Tumor, Adult
Keywords: Cannabis
Tumors
Observational Study
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 27
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Likelihood of Accruing Participants: Feasibility of Enrollment
timeFrame: Approximately 48 months
Secondary outcomes:
Other outcomes:
measure: Amount of Interest
timeFrame: Approximately 48 months
measure: Eligibility
timeFrame: Approximately 48 months
measure: Enrollment
timeFrame: Approximately 48 months
measure: Completion of Assessments
timeFrame: Baseline to one month follow up, Approximately 48 months
measure: Study Completion
timeFrame: Approximately 48 months
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Boulder
country: United States
facility: University of Colorado Boulder
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Angela Bryan, PhD
role: PRINCIPAL_INVESTIGATOR
References: