Investigation of Cannabis for Pain and Inflammation in Lung Cancer
| Status: | Withdrawn |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - 60 |
| Updated: | 10/20/2018 |
| Start Date: | February 2016 |
| End Date: | December 2021 |
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.
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.
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.
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.
Inclusion Criteria:
1. Diagnosis of Lung Cancer receiving RT.
2. Age 21- 60
3. Able to give informed consent, and comply with study procedures.
4. 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:
1. 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.
2. 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.
3. Women who are not practicing an effective form of birth control (condoms, diaphragm,
birth control pill, IUD) or currently pregnant
4. Current (weekly) use of cannabis.
5. Participants on supplemental oxygen
6. Participants with a history of substance use disorder other than nicotine, such as
opiate disorder
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