Cannabis Use in Cancer Patients

NCT03617692 | Completed Results DMC

• 1 other identifier: 18-0836.cc
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Solid Tumor, Adult

Keywords

Cannabis; Tumors; Observational Study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Amount of Interest

  Approximately 48 months

• Eligibility

  Approximately 48 months

• Enrollment

  Approximately 48 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following 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.
• Be a female or male aged at least 21 years.
• Have a diagnosis of any solid tumor type who has or is undergoing either curative or palliative treatment
• Have intent or interest to use cannabis to treat their symptoms.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• 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 M.D.
• Premenopausal females who are pregnant or trying to become pregnant. Note that pregnancy testing will not be required.
• A Telephone Interview for Cognitive Status (TICS) score indicating moderate or severe cognitive impairment at screening

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (2)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

University of Colorado Boulder

Boulder, Colorado, 80309, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood sample

MeSH Terms

Conditions

Marijuana Abuse; Neoplasms

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Angela Bryan, PhD
• Organization: University of Colorado Boulder

Angela.Bryan@Colorado.EDU

3034929549

Study Officials

• Angela Bryan, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 6, 2018
• Study Start: December 4, 2018
• Primary Completion: December 12, 2022
• Study Completion: December 12, 2022
• Last Updated: June 11, 2024
• Results First Posted: June 11, 2024

Record last verified: 2024-06

Locations

US (2)