Trial Outcomes & Findings for Cannabis Use in Cancer Patients (NCT NCT03617692)

NCT ID: NCT03617692

Last Updated: 2024-06-11

Results Overview

Enroll a minimum of 30 patients and demonstrate reasonable compliance with study procedures within 54 months of active recruiting.

• Recruitment status: COMPLETED
• Target enrollment: 27 participants
• Primary outcome timeframe: Approximately 48 months
• Results posted on: 2024-06-11

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	27
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cannabis Use in Cancer Patients

Baseline characteristics by cohort

Measure	Oral Cannabis n=27 Participants 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.
Age, Continuous	53.4 years STANDARD_DEVIATION 15.6 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 48 months

Population: Number of participants assessed for enrollment

Enroll a minimum of 30 patients and demonstrate reasonable compliance with study procedures within 54 months of active recruiting.

Outcome measures

Measure	Oral Cannabis n=41 Participants 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.
Likelihood of Accruing Participants: Feasibility of Enrollment Enrolled	27 Participants
Likelihood of Accruing Participants: Feasibility of Enrollment Completed study	24 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Approximately 48 months

Population: Number of individuals who contacted the research team about participation in the study

Study officials will document how many patients contact the research team regarding their participation in the study

Outcome measures

Measure

Oral Cannabis n=134 Participants 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.

Amount of Interest

134 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Approximately 48 months

Population: Number of individuals who contacted the research team about participation in the study

Study officials will document how many patients are and are not eligible to participate in the study.

Outcome measures

Measure	Oral Cannabis n=134 Participants 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 Eligible after pre-screening	41 Participants
Eligibility Not eligible after pre-screening	5 Participants
Eligibility Did not complete pre-screening	88 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Approximately 48 months

Population: Number of individuals found eligible after pre-screening

Study officials will document how many patients actually proceed to enrollment in the study.

Outcome measures

Measure	Oral Cannabis n=41 Participants 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.
Enrollment Enrolled	27 Participants
Enrollment Not enrolled	14 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to one month follow up, Approximately 48 months

Population: Number of participants enrolled

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).

Outcome measures

Measure	Oral Cannabis n=27 Participants 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.
Completion of Assessments Completed baseline assessment	27 Participants
Completion of Assessments Completed pre-acute cannabis use assessment	25 Participants
Completion of Assessments Completed 1 hour post-acute cannabis use assessment	25 Participants
Completion of Assessments Completed 2 hour post-acute cannabis use assessment	25 Participants
Completion of Assessments Completed one month follow up assessment	24 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Approximately 48 months

Population: Number of participants enrolled

Study officials will document how many participants complete the study in its entirety.

Outcome measures

Measure

Oral Cannabis n=27 Participants 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.

Study Completion

24 Participants

Adverse Events

Oral Cannabis

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

Oral Cannabis n=27 participants at risk 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.

Cardiac disorders Increased heart rate (over 100 beats per minute)

3.7% 1/27 • Number of events 1 • 3 months Participants were asked about the occurrence of adverse events at study visits.

Additional Information

Angela Bryan, PhD

University of Colorado Boulder

Phone: 3034929549

Email: Angela.Bryan@Colorado.EDU

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place