Cannabis Use in Cancer Patients

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.

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 Stage III-IV Non-Small Cell Lung Cancer (NSCLC) or other
comparable tumor types

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