Investigation of Cannabis for Pain and Inflammation in Lung Cancer
Primary Purpose
Lung Cancer
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Smoked Cannabis High CBD/low THC
Smoked Placebo Cannabis Low CBD/low THC
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Lung Cancer receiving RT.
- Age 21- 60
- Able to give informed consent, and comply with study procedures.
- History of previous experience with smoking or marijuana. On PFTs (Pulmonary Function Tests), participants must have an FEV1 (Forced Expiratory Volume in 1 second) of ≥ 1.2 liters/second or ≥ 50% predicted using the CDC reference value calculator.
Exclusion Criteria:
- Meet DSM-V criteria for current major psychiatric illness, such as bipolar disorder, major depression, active suicidal intent, or psychosis, that could be exacerbated by the administration of cannabis.
- Meet criteria for major neurological disorder, such as mild cognitive impairment or neurodegenerative disorders (such as movement disorders, dementia), that could be exacerbated by the administration of cannabis.
- Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD) or currently pregnant
- Current (weekly) use of cannabis.
- Participants on supplemental oxygen
- Participants with a history of substance use disorder other than nicotine, such as opiate disorder
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Smoked Cannabis High CBD/low THC
Smoked Placebo Cannabis Low CBD/low THC
Arm Description
Participants will visit the research laboratory 3-5 days a week over 6 weeks to be administered 1-2 Cannabis cigarettes (15.76% CBD; 3.11% -9-THC) over the course of 2-3 hours.
Participants will visit the research laboratory 3-5 days a week over 6 weeks to be administered 1-2 Cannabis cigarettes Cannabis (0.0% CBD/ 0.01% -9-THC) over the course of 2-3 hours.
Outcomes
Primary Outcome Measures
Change in pain ratings using The McGill Pain Questionnaire
Participants will be asked to rate their pain over the 6 weeks of receiving active cannabis vs placebo.
Change in sickness-related impairment using the Sickness Impact Profile Questionnaire
Participants will be asked to rate physical symptoms for the 6 weeks of the study.
changes in physical and emotional well being using RAND 36 item medical outcomes survey
Changes in symptoms of pain using 9 item Brief Pain Inventory
Changes in quality of life using the Multidimensional Index of Life Quality (MILQ) Questionnaire
changes in symptoms of pain, tiredness and well-being using the Edmonton Symptom
Change in symptoms of pain, mood and appetite using the System (ESAS) Questionnaire
Secondary Outcome Measures
Assessment of subjective effects using VAS
The visual analog scales (VAS) will be used to investigate the subjective effects while participants are in the laboratory.
change in eating measured using food diary
Participants will be asked to complete a food diary during the 6 weeks and will be weighed weekly during the study.
Change in mood using the Hamilton Depression Rating Scale
Hamilton Depression Rating Scale will be used to assess mood during the 6 weeks of the study.
Change in mood Hamilton Anxiety Rating Scale
Hamilton Anxiety Rating Scale will be used to assess mood during the 6 weeks of the study.
Change in mood using the Montgomery-Asberg Depression Rating Scale
The Montgomery-Asberg Depression Rating Scale will be used to assess the participants' mood throughout the six weeks of the study.
Change in mood and quality of life using the Columbia Suicide Severity Rating Scale
change in cognitive status using the Short Portable Mental Status Questionnaire (SPMSQ)
Change in symptom prevalence using the Memorial Symptom Assessment Scale (MSAS)
Change in physiological state using the Mental Health Inventory-5 (MHI-5) Questionnaire
Change in opioid use using the Opioid use Questionnaire
Participants will be asked to provide to the number of opioid medications taken. The amount of opioids used will be converted to oral morphine equivalents and tallied for each day.
Full Information
NCT ID
NCT02675842
First Posted
January 28, 2016
Last Updated
October 28, 2021
Sponsor
New York State Psychiatric Institute
1. Study Identification
Unique Protocol Identification Number
NCT02675842
Brief Title
Investigation of Cannabis for Pain and Inflammation in Lung Cancer
Official Title
Investigation of Cannabis for Pain and Inflammation in Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Withdrawn
Why Stopped
funding
Study Start Date
undefined (undefined)
Primary Completion Date
October 28, 2021 (Actual)
Study Completion Date
October 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Radiation therapy to the chest is used in late stage lung cancer, and it often leads to inflammation of the esophagus. The inflammation is expected to occur in about 75% of patient, and usually begin within a week of starting radiation therapy. The esophagitis causes pain and difficulty eating. It can also result in stopping or delaying treatment.Radiation therapy to the chest is used in late stage lung cancer, and it often leads to inflammation of the esophagus. The inflammation is expected to occur in about 75% of patient, and usually begin within a week of starting radiation therapy. The esophagitis causes pain and difficulty eating. The endocannabinoid system is prominent in the gastrointestinal system, and cannabis has been shown to greatly inhibit inflammation. The compound (-)-trans-Δ9-tetrahydrocannabinol (Δ-9-THC) has effects that reduce inflammation and pain. Cannabidiol is a component of cannabis that does not produce subjective or intoxicating effects, but also has prominent anti-inflammatory properties.
The goal of this study is to perform a double-blind, placebo-controlled study to investigate the efficacy of cannabis, compared to placebo, in participants undergoing RT (Radiation Therapy) for lung cancer. Cannabis that has a high concentration of cannabidiol will be used , which is a cannabinoid that does not change perception or produce intoxication, and low in Δ-9-THC. In this way, the hope is to maximize the benefit of cannabis, while lowering the possible side effects of cannabis in medically ill participants.
Detailed Description
Study Outline
Patients will be referred to the study from their physician, who will have the patients medically cleared for participation.
The patients will then undergo additional screening for the study. A study physician will review all study procedures with potential participants, including the potential side effects. Patients will be shown the facilities and informed of being monitored at all times.
Patients will be randomized using a randomization and assigned to one of two groups: cannabis (15.76% CBD; 3.11% Δ-9 -THC) vs "placebo" cannabis (0.0% CBD/ 0.01% Δ-9-THC).
Participants will visit the Marijuana Research Laboratory, 3-5 days a week over 6 weeks to be administered 1-2 cannabis cigarettes over the course of a 2-3 hour session. Two cannabis conditions will be tested: Placebo (0.01% THC; 0.00% CBD) and CBD:THC (15.76% CBD; 3.11% THC) provided by the National Institute on Drug Abuse.
Participants will undergo baseline measurements of mood, and physical symptoms and will then be given 2 NIDA (National Institute on Drug Abuse) cannabis cigarettes, which can be consumed as smoking or with a vaporizer in a ventilated room. After the 90 minutes of cannabis availability end, participants will be asked to remain in the laboratory for an additional 45 minutes to allow the effects of the cannabis to wear off.
Participants will undergo baseline measurements of mood, and physical symptoms and will then be given the equivalent of 2 NIDA cannabis cigarettes. Cardiovascular and subjective effects measures of mood, abuse liability and drug tolerability will be collected at baseline, at the end of the 90 minutes of cannabis availability and at the end of the session. Detailed measures of food intake (caloric content, macronutrient intake) will be recorded beginning immediately after cannabis administration and for the duration of the session. In addition to visual analog scales, participants will be asked to complete measures of mood and cannabis effects at screening, before, during and after the session. Participants will be assessed at the end of the session by an experienced clinician.
Opioid use: Participants will be asked to provide the number of opioid medications taken as follows: 1) at baseline (in the week prior to starting sessions); and 2) at each session, participants will be asked about opioid use since the previous session. The amount of opioids used will be converted to oral morphine equivalents and tallied for each day.
Food intake: Participants will be asked to complete a daily food diary for the duration of the study. Detailed measures of food intake (caloric content, macronutrient intake) will also be recorded during the cannabis sessions. Participants will also be weighed weekly.
PET (Positron Emission Tomography) scans: As part of their clinical care, patients receive a PET/CT scan using the radiotracer [18F]FDG with a low dose CT for attenuation correction and anatomic localization. This data will be requested from the PET center, with the participants consent, in order to assess the extent of esophagitis in the two groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Smoked Cannabis High CBD/low THC
Arm Type
Active Comparator
Arm Description
Participants will visit the research laboratory 3-5 days a week over 6 weeks to be administered 1-2 Cannabis cigarettes (15.76% CBD; 3.11% -9-THC) over the course of 2-3 hours.
Arm Title
Smoked Placebo Cannabis Low CBD/low THC
Arm Type
Placebo Comparator
Arm Description
Participants will visit the research laboratory 3-5 days a week over 6 weeks to be administered 1-2 Cannabis cigarettes Cannabis (0.0% CBD/ 0.01% -9-THC) over the course of 2-3 hours.
Intervention Type
Drug
Intervention Name(s)
Smoked Cannabis High CBD/low THC
Intervention Description
Participants will visit the research laboratory 3-5 days a week over 6 weeks to be administered 1-2 Cannabis cigarettes (15.76% CBD; 3.11% -9-THC) over the course of 2-3 hours.
Intervention Type
Drug
Intervention Name(s)
Smoked Placebo Cannabis Low CBD/low THC
Intervention Description
Participants will visit the research laboratory 3-5 days a week over 6 weeks to be administered 1-2 Cannabis cigarettes Cannabis (0.0% CBD/ 0.01% -9-THC) over the course of 2-3 hours.
Primary Outcome Measure Information:
Title
Change in pain ratings using The McGill Pain Questionnaire
Description
Participants will be asked to rate their pain over the 6 weeks of receiving active cannabis vs placebo.
Time Frame
6 weeks
Title
Change in sickness-related impairment using the Sickness Impact Profile Questionnaire
Description
Participants will be asked to rate physical symptoms for the 6 weeks of the study.
Time Frame
6 weeks
Title
changes in physical and emotional well being using RAND 36 item medical outcomes survey
Time Frame
6 weeks
Title
Changes in symptoms of pain using 9 item Brief Pain Inventory
Time Frame
6 weeks
Title
Changes in quality of life using the Multidimensional Index of Life Quality (MILQ) Questionnaire
Time Frame
6 weeks
Title
changes in symptoms of pain, tiredness and well-being using the Edmonton Symptom
Time Frame
6 weeks
Title
Change in symptoms of pain, mood and appetite using the System (ESAS) Questionnaire
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Assessment of subjective effects using VAS
Description
The visual analog scales (VAS) will be used to investigate the subjective effects while participants are in the laboratory.
Time Frame
6 weeks
Title
change in eating measured using food diary
Description
Participants will be asked to complete a food diary during the 6 weeks and will be weighed weekly during the study.
Time Frame
weekly for 6 weeks
Title
Change in mood using the Hamilton Depression Rating Scale
Description
Hamilton Depression Rating Scale will be used to assess mood during the 6 weeks of the study.
Time Frame
6 weeks
Title
Change in mood Hamilton Anxiety Rating Scale
Description
Hamilton Anxiety Rating Scale will be used to assess mood during the 6 weeks of the study.
Time Frame
6 weeks
Title
Change in mood using the Montgomery-Asberg Depression Rating Scale
Description
The Montgomery-Asberg Depression Rating Scale will be used to assess the participants' mood throughout the six weeks of the study.
Time Frame
6 weeks
Title
Change in mood and quality of life using the Columbia Suicide Severity Rating Scale
Time Frame
6 weeks
Title
change in cognitive status using the Short Portable Mental Status Questionnaire (SPMSQ)
Time Frame
6 weeks
Title
Change in symptom prevalence using the Memorial Symptom Assessment Scale (MSAS)
Time Frame
6 weeks
Title
Change in physiological state using the Mental Health Inventory-5 (MHI-5) Questionnaire
Time Frame
6 weeks
Title
Change in opioid use using the Opioid use Questionnaire
Description
Participants will be asked to provide to the number of opioid medications taken. The amount of opioids used will be converted to oral morphine equivalents and tallied for each day.
Time Frame
Daily for 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Lung Cancer receiving RT.
Age 21- 60
Able to give informed consent, and comply with study procedures.
History of previous experience with smoking or marijuana. On PFTs (Pulmonary Function Tests), participants must have an FEV1 (Forced Expiratory Volume in 1 second) of ≥ 1.2 liters/second or ≥ 50% predicted using the CDC reference value calculator.
Exclusion Criteria:
Meet DSM-V criteria for current major psychiatric illness, such as bipolar disorder, major depression, active suicidal intent, or psychosis, that could be exacerbated by the administration of cannabis.
Meet criteria for major neurological disorder, such as mild cognitive impairment or neurodegenerative disorders (such as movement disorders, dementia), that could be exacerbated by the administration of cannabis.
Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD) or currently pregnant
Current (weekly) use of cannabis.
Participants on supplemental oxygen
Participants with a history of substance use disorder other than nicotine, such as opiate disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Martinez, MD
Organizational Affiliation
Columbia University/NYSPI
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Investigation of Cannabis for Pain and Inflammation in Lung Cancer
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