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Cannabis Use in Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03617692
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date July 23, 2018
First Posted Date August 6, 2018
Last Update Posted Date March 9, 2020
Actual Study Start Date December 4, 2018
Estimated Primary Completion Date December 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 5, 2020)
Likelihood of Accruing Participants: Feasibility of Enrollment [ Time Frame: 18 months ]
Enroll a minimum of 30 patients and demonstrate reasonable compliance with study procedures within six months of active recruiting.
Original Primary Outcome Measures
 (submitted: July 31, 2018)
Likelihood of Accruing Participants: Feasibility of Enrollment [ Time Frame: Six months ]
Enroll a minimum of 30 patients and demonstrate reasonable compliance with study procedures within six months of active recruiting.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: March 5, 2020)
  • Amount of Interest [ Time Frame: 18 months ]
    Study officials will document how many patients contact the research team regarding their participation in the study
  • Eligibility [ Time Frame: 18 months ]
    Study officials will document how many patients are and are not eligible to participate in the study.
  • Enrollment [ Time Frame: 18 months ]
    Study officials will document how many patients actually proceed to enrollment in the study.
  • Completion of Assessments [ Time Frame: Baseline to one month follow up, in an eighteen month time frame ]
    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).
  • Study Completion [ Time Frame: 18 months ]
    Study officials will document how many participants complete the study in its entirety.
Original Other Pre-specified Outcome Measures
 (submitted: July 31, 2018)
  • Amount of Interest [ Time Frame: Six months ]
    Study officials will document how many patients contact the research team regarding their participation in the study
  • Eligibility [ Time Frame: Six months ]
    Study officials will document how many patients are and are not eligible to participate in the study.
  • Enrollment [ Time Frame: Six months ]
    Study officials will document how many patients actually proceed to enrollment in the study.
  • Completion of Assessments [ Time Frame: Baseline to one month follow up, in a six month time frame ]
    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).
  • Study Completion [ Time Frame: Six months ]
    Study officials will document how many participants complete the study in its entirety.
 
Descriptive Information
Brief Title Cannabis Use in Cancer Patients
Official Title Effects of Cannabis Use in Cancer Patients: A Feasibility Study
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 their session in our mobile pharmacology and phlebotomy lab (Ta1-Tc1) so that we may examine the acute effects of the product. The Mobile Lab session will take place at a location of their choosing up to 90 minutes drive-time away from the CUChange Lab. The final follow-up will be one month later via an online survey sent directly to the participant via email.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Whole blood sample
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
Condition Solid Tumor, Adult
Intervention Not Provided
Study Groups/Cohorts 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 31, 2018)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 20, 2021
Estimated Primary Completion Date December 20, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Angela Bryan, PhD 303-492-8264 angela.bryan@colorado.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03617692
Other Study ID Numbers 18-0836.cc
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor University of Colorado, Denver
Collaborators Not Provided
Investigators
Principal Investigator: Angela Bryan, PhD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date March 2020