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Effects of Cannabis Use in Stage III-IV Non-small Cell Lung Cancer Patients

Trial Status: Active

This trial studies the effects of cannabis use on stage III-IV non-small cell lung cancer patients undergoing treatment for their cancer. Studying the effects of different types of cannabis and cannabinoids (the different constituent parts of cannabis) on cancer-related symptoms, quality of life, and cognition when used by patients undergoing treatment for cancer, may help doctors inform patient choices and future harm reduction efforts.

Inclusion Criteria

  • Provision to sign and date the consent form
  • Stated willingness to comply with all study procedures and be available for the duration of the study
  • Have a diagnosis of stage III-IV non-small cell lung cancer (NSCLC) or other comparable tumor types
  • Have intent to use Cannabis to treat their symptoms

Exclusion Criteria

  • Report of other non-prescription drug use, such as cocaine, heroin, methamphetamine in the past 60 days
  • Actively seeking or in treatment for any substance use disorder
  • Acute illness other than cancer that could affect cognition or compliance per the decision of the study Doctor of Medicine (M.D.)
  • Premenopausal females who are pregnant or trying to become pregnant. Participants who become pregnant while participating in the study will also no longer be eligible for participation
  • A Telephone Interview for Cognitive Status (TICS) score indicating moderate or severe cognitive impairment at screening

Colorado

Aurora
University of Colorado Hospital
Status: ACTIVE
Contact: Angela Bryan
Phone: 303-492-8264
Boulder
University of Colorado – Boulder
Status: ACTIVE
Contact: Angela Bryan
Phone: 303-492-8264

PRIMARY OBJECTIVE:

I. To demonstrate the number of contacts necessary to enroll 30 eligible patients and demonstrate reasonable compliance with study procedures within six months of active recruiting.

OUTLINE:

Patients use their marijuana (cannabis) product of choice orally (PO) for 2 weeks then undergo blood collection and complete questionnaires, memory and thinking assessments at baseline then at 1 and 2 hours after each cannabis use.

After completion of study, patients are followed up at 1 month.

Trial Phase Phase NA

Trial Type Observational

Lead Organization
University of Colorado Hospital

Principal Investigator
Angela Bryan

  • Primary ID 18-0836
  • Secondary IDs NCI-2020-01067
  • Clinicaltrials.gov ID NCT03617692