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Trial record 8 of 18 for:    marijuana | Recruiting, Not yet recruiting, Active, not recruiting, Enrolling by invitation Studies | ( Map: Colorado, United States )

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 : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease
Non-small Cell Lung Cancer Metastatic

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.


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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Cannabis Use in Cancer Patients: A Feasibility Study
Actual Study Start Date : December 4, 2018
Estimated Primary Completion Date : January 20, 2020
Estimated Study Completion Date : January 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Amount of Interest [ Time Frame: Six months ]
    Study officials will document how many patients contact the research team regarding their participation in the study

  2. Eligibility [ Time Frame: Six months ]
    Study officials will document how many patients are and are not eligible to participate in the study.

  3. Enrollment [ Time Frame: Six months ]
    Study officials will document how many patients actually proceed to enrollment in the study.

  4. 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).

  5. Study Completion [ Time Frame: Six months ]
    Study officials will document how many participants complete the study in its entirety.


Biospecimen Retention:   Samples Without DNA
Whole blood sample


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03617692


Contacts
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Contact: Angela Bryan, PhD 303-492-8264 angela.bryan@colorado.edu

Locations
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United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Angela Bryan, PhD    303-588-3335    angela.bryan@colorado.edu   
Principal Investigator: Angela Bryan, PhD         
University of Colorado Boulder Not yet recruiting
Boulder, Colorado, United States, 80309
Contact: Angela Bryan, PhD    303-492-8264    angela.bryan@colorado.edu   
Principal Investigator: Angela Bryan, PhD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Angela Bryan, PhD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03617692     History of Changes
Other Study ID Numbers: 18-0836.cc
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
Stage III
Stage IV
Cannabis
Lung Cancer
Tumors
Observational Study
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders