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Cannabis Use in Cancer Patients

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ClinicalTrials.gov Identifier: NCT03617692
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : February 6, 2019
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 February 6, 2019
Actual Study Start Date December 4, 2018
Estimated Primary Completion Date January 20, 2020   (Final data collection date for primary outcome measure)
Current 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03617692 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current 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.
Original Other Pre-specified Outcome Measures Same as current
 
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 lung cancer patients.
Detailed Description

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.

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 stage III-IV NSCLC patients, as well as those with other comparable and advanced tumor types.
Condition Non-small Cell Lung Cancer Metastatic
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 January 20, 2021
Estimated Primary Completion Date January 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 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
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 February 2019