Lung CancerPhase 1NCT02675842
Investigation of Cannabis for Pain and Inflammation in Lung Cancer
A Phase 1 study testing Smoked Cannabis High CBD/low THC in people with Lung Cancer, run by New York State Psychiatric Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Smoked Cannabis High CBD/low THC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento 28 Oct 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Smoked Cannabis High CBD/low THC, Smoked Placebo Cannabis Low CBD/low THC
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoked Cannabis High CBD/low THCDrug
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.
Smoked Placebo Cannabis Low CBD/low THCDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Smoked Cannabis High CBD/low THC | Active comparator | 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. Receives: Drug: Smoked Cannabis High CBD/low THC |
| Smoked Placebo Cannabis Low CBD/low THC | Placebo comparator | 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. Receives: Drug: Smoked Placebo Cannabis Low CBD/low THC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
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.
Measured: 6 weeks
changes in physical and emotional well being using RAND 36 item medical outcomes survey
Measured: 6 weeks
Changes in symptoms of pain using 9 item Brief Pain Inventory
Measured: 6 weeks
Changes in quality of life using the Multidimensional Index of Life Quality (MILQ) Questionnaire
Measured: 6 weeks
changes in symptoms of pain, tiredness and well-being using the Edmonton Symptom
Measured: 6 weeks
Change in symptoms of pain, mood and appetite using the System (ESAS) Questionnaire
Measured: 6 weeks
Secondary outcomes (10)
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.
Measured: 6 weeks
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.
Measured: weekly for 6 weeks
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.
Measured: 6 weeks
Change in mood Hamilton Anxiety Rating Scale
Hamilton Anxiety Rating Scale will be used to assess mood during the 6 weeks of the study.
Measured: 6 weeks
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.
Measured: 6 weeks
Change in mood and quality of life using the Columbia Suicide Severity Rating Scale
Measured: 6 weeks
change in cognitive status using the Short Portable Mental Status Questionnaire (SPMSQ)
Measured: 6 weeks
Change in symptom prevalence using the Memorial Symptom Assessment Scale (MSAS)
Measured: 6 weeks
Change in physiological state using the Mental Health Inventory-5 (MHI-5) Questionnaire
Measured: 6 weeks
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.
Measured: Daily for 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Primary completion28 Oct 2021
- Study completion28 Oct 2021
Why it stopped: funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana Martinez, New York State Psychiatric Institute
- Investigators
- Diana Martinez, MD, Principal investigator, Columbia University/NYSPI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675842
- Sponsor's protocol ID
- 7221
- Status last verified
- Oct 2021
- First submitted
- 28 Jan 2016
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Cannabis for Pain and Inflammation in Lung Cancer
- ClinicalTrials.gov ID
- NCT02675842
- Acronym / sponsor ID
- 7221
- Conditions
- Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 28 Oct 2021 (actual)
- First posted
- 5 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoked Cannabis High CBD/low THC | Active comparator | Drug: Smoked Cannabis High CBD/low THCParticipants 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. |
| Smoked Placebo Cannabis Low CBD/low THC | Placebo comparator | Drug: Smoked Placebo Cannabis Low CBD/low THCParticipants 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. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoked Cannabis High CBD/low THCParticipants 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. | Drug | Smoked Cannabis High CBD/low THC |
| Smoked Placebo Cannabis Low CBD/low THCParticipants 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. | Drug | Smoked Placebo Cannabis Low CBD/low THC |
Primary outcome
Change in pain ratings using The McGill Pain Questionnaire
Time frame: 6 weeks
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
Time frame: 6 weeks
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
Time frame: 6 weeks
Changes in symptoms of pain using 9 item Brief Pain Inventory
Time frame: 6 weeks
Changes in quality of life using the Multidimensional Index of Life Quality (MILQ) Questionnaire
Time frame: 6 weeks
changes in symptoms of pain, tiredness and well-being using the Edmonton Symptom
Time frame: 6 weeks
Change in symptoms of pain, mood and appetite using the System (ESAS) Questionnaire
Time frame: 6 weeks
10 secondary outcomes
Assessment of subjective effects using VAS
Time frame: 6 weeks
change in eating measured using food diary
Time frame: weekly for 6 weeks
Change in mood using the Hamilton Depression Rating Scale
Time frame: 6 weeks
Change in mood Hamilton Anxiety Rating Scale
Time frame: 6 weeks
Change in mood using the Montgomery-Asberg Depression Rating Scale
Time frame: 6 weeks
Change in mood and quality of life using the Columbia Suicide Severity Rating Scale
Time frame: 6 weeks
change in cognitive status using the Short Portable Mental Status Questionnaire (SPMSQ)
Time frame: 6 weeks
Change in symptom prevalence using the Memorial Symptom Assessment Scale (MSAS)
Time frame: 6 weeks
Change in physiological state using the Mental Health Inventory-5 (MHI-5) Questionnaire
Time frame: 6 weeks
Change in opioid use using the Opioid use Questionnaire
Time frame: Daily for 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Martinez, MD principal investigator
Columbia University/NYSPI
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Smoked Cannabis High CBD/low THC in people with Lung Cancer, run by New York State Psychiatric Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain ratings using The McGill Pain Questionnaire (time frame: 6 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.