Chronic PainPhase 1NCT02683018
Investigation of Cannabis for Chronic Pain and Palliative Care
A Phase 1 study testing Smoked Cannabis High CBD/low THC in people with Chronic Pain, run by New York State Psychiatric Institute.
Trial summary
The use of cannabis for severe medical conditions is being legalized in different states, increasing the mandate to make cannabis legal for medically ill patients. However, there is a lack of placebo-controlled studies investigating the efficacy of cannabis. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Chronic Pain
- 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
- One of the medical diagnoses (cancer, amyotrophic lateral sclerosis, Parkinson's disease, spinal cord injury, neuropathy, and phantom limb pain, thalamic pain, pain related to injury of nerve plexus/plexi, and neuropathic facial pain), with reports of pain (at least 3 on item 3 on the 9 item Brief Pain Inventory)that remains despite their current medical treatment.
- Age 21-60
- Able to give informed consent, and comply with study procedures
- Experience inhaling substances.
Who cannot join
- Meet DSM-V criteria for current major psychiatric illness, such as bipolar disorder, major depression, active suicidality, 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 substance use disorder involving marijuana or opioids.
About this study
The use of cannabis for severe medical conditions is being legalized in different states, increasing the mandate to make cannabis legal for medically ill patients. However, there is a lack of placebo-controlled studies investigating the efficacy of cannabis. Dronabinol (synthetic, oral Δ-9-THC) is FDA approved for the appetite stimulation in AIDS-related anorexia and nausea/vomiting in chemotherapy patients. Nabilone, a synthetic analogue of THC, is approved for nausea/vomiting in chemotherapy patients. These medications have been found to be effective for these disorders, but there remains an interest in studying cannabis, partly due to the numerous cannabinoids contained within the cannabis plant. Among these is cannabidiol, which does not produce subjective effects, but has been shown to have potent anti-inflammatory effects. In addition, there is data indicating that cannabidiol may be effective for neuropathic pain and nausea/vomiting.
The goal is to investigate the effects of high CBD/low THC cannabis on symptoms such as pain, nausea/vomiting, and quality of life in seriously ill participants. While there is data beginning to emerge that cannabis may have a beneficial effect on these symptoms, there are few placebo controlled, double-blind studies. Additionally, the administration of cannabis to medically ill patients may be limited by its subjective effects, such as anxiety, intoxication, or paranoia. Most cannabis available today has high levels of Δ-9-THC (about 15%). By using cannabis that is high in CBD, but low in - Δ-9-THC, it is hypothesized that some of these effects can be avoid, while maximizing the therapeutic effects, if any.
Read the detailed description
The goal of this study is to perform a double-blind, placebo-controlled study to investigate the efficacy of cannabis, compared to placebo, in medically ill participants seeking relief symptoms such as pain, nausea, and vomiting. Participants who meet criteria for severe conditions will be referred from their clinicians . Cannabis that has a high concentration of cannabidiol, which is a cannabinoid that does not change perception or produce intoxication, and low in Δ-9-THC will be used. In this way, the hope is to maximize the benefit of cannabis, while lowering the possible side effects of cannabis in medically ill participants.
The overall goal of this study is to compare active high cannabidiol (CBD)/ low (-)-trans-Δ9- tetrahydrocannabinol (THC) cannabis vs placebo cannabis in patients with serious medical disorders. Participants will be referred from clinicians and will come to the laboratory daily (3-5 times weekly) for cannabis (15.76% CBD; 3.11% Δ-9-THC) vs placebo (0.0% CBD/ 0.01% Δ-9-THC). The cannabis will be vaporized or smoked as a cannabis cigarette. The participants can choose which option they prefer. The cross-over design will be used where participants receive 2 weeks of active cannabis vs two weeks of placebo in counterbalanced order, with participants blinded to the condition. The outcome measures primarily include measures of pain, with secondary measures of mood, nausea/appetite, quality of life, and the both the potentially positive and negative subjective effects of cannabis (e.g., high, mellow, anxious, paranoid).
- Conditions
- Chronic Pain
- Being tested
- Smoked Cannabis High CBD/low THC, Smoked Placebo Cannabis Low CBD/low THC
- Medical subject headings
- Chronic Pain
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
Also called cannabis cigarettes (15.76% CBD; 3.11% THC)
Participants will visit the Marijuana Research Laboratory 3-5 weekdays per week for 4 weeks to be administered 1-2 cannabis cigarettes (15.76% CBD; 3.11% THC) over the course of a 2-3 hour session.
Smoked Placebo Cannabis Low CBD/low THCDrug
Also called cannabis cigarettes (0.01% THC; 0.00% CBD)
Participants will visit the Marijuana Research Laboratory 3-5 weekdays per week for 4 weeks to be administered 1-2 cannabis cigarettes (0.01% THC; 0.00% CBD) over the course of a 2-3 hour session.
| Study group | Role | What they receive |
|---|---|---|
| Smoked Cannabis High CBD/low THC | Active comparator | Participants will visit the Marijuana Research Laboratory 3-5 weekdays per week for 4 weeks to be administered 1-2 Smoked Cannabis High CBD/low THC cigarettes (15.76% CBD; 3.11% THC) over the course of a 2-3 hour session. Receives: Drug: Smoked Cannabis High CBD/low THC |
| Smoked Placebo Cannabis Low CBD/low THC | Placebo comparator | Participants will visit the Marijuana Research Laboratory 3-5 weekdays per week for 4 weeks to be administered 1-2 cannabis cigarettes (0.01% THC; 0.00% CBD) over the course of a 2-3 hour session. 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 4 weeks of receiving active cannabis vs placebo.
Measured: 4 weeks
Change in sickness-related impairment using the Sickness Impact Profile
Participants will be asked to rate physical symptoms for the 4 weeks of the study.
Measured: 4 weeks
changes in physical and emotional well being using the RAND-36 item medical outcomes survey, a health-related quality of life survey instrument
RAND-36 item medical outcomes survey taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.
Measured: 4 weeks
Changes in symptoms of pain using the 9 item Brief Pain Inventory
Measured: 4 weeks
Secondary outcomes (11)
Change in cognitive status using the Short Portable Mental Status Questionnaire (SPMSQ)
Measured: 4 weeks
Change in symptom prevalence, characteristics and degree of stress using the Memorial Symptom Assessment Scale (MSAS)
Measured: 4 weeks
Change in the psychological state and psychological well being using the Mental Health Inventory-5 (MHI-5)
Measured: 4 weeks
Changes in quality of life using the Multidimensional Index of Life Quality (MILQ) Questionnaire
Measured: 4 weeks
Changes in quality of life using the McGill Quality of Life Questionnaire
Measured: 4 weeks
Change in symptoms of pain, mood and appetite using the Edmonton Symptom Assessment System (ESAS)
Measured: 4 weeks
Memorial Symptom Assessment Scale (MSAS)
Measured: 4 weeks
Change in mood using the Hamilton Depression Rating Scale
Measured: 4 weeks
Change in mood Hamilton Anxiety Rating Scale
Measured: 4 weeks
Change in mood using the Montgomery-Asberg Depression Rating Scale
Measured: 4 weeks
Change in mood and quality of life using the Columbia Suicide Severity Rating Scale
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Primary completion28 Oct 2021
- Study completion28 Oct 2021 (estimated)
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 Chronic PainStudies 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
- Crossover
- 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, New York Sate Psychiatric Institute/ Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683018
- Sponsor's protocol ID
- 7220
- Status last verified
- Oct 2021
- First submitted
- 11 Feb 2016
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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 Chronic Pain and Palliative Care
- ClinicalTrials.gov ID
- NCT02683018
- Acronym / sponsor ID
- 7220
- Conditions
- Chronic Pain
- 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 (estimated)
- First posted
- 17 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.
The use of cannabis for severe medical conditions is being legalized in different states, increasing the mandate to make cannabis legal for medically ill patients. However, there is a lack of placebo-controlled studies investigating the efficacy of cannabis. Dronabinol (synthetic, oral Δ-9-THC) is FDA approved for the appetite stimulation in AIDS-related anorexia and nausea/vomiting in chemotherapy patients. Nabilone, a synthetic analogue of THC, is approved for nausea/vomiting in chemotherapy patients. These medications have been found to be effective for these disorders, but there remains an interest in studying cannabis, partly due to the numerous cannabinoids contained within the cannabis plant. Among these is cannabidiol, which does not produce subjective effects, but has been shown to have potent anti-inflammatory effects. In addition, there is data indicating that cannabidiol may be effective for neuropathic pain and nausea/vomiting.
The goal is to investigate the effects of high CBD/low THC cannabis on symptoms such as pain, nausea/vomiting, and quality of life in seriously ill participants. While there is data beginning to emerge that cannabis may have a beneficial effect on these symptoms, there are few placebo controlled, double-blind studies. Additionally, the administration of cannabis to medically ill patients may be limited by its subjective effects, such as anxiety, intoxication, or paranoia. Most cannabis available today has high levels of Δ-9-THC (about 15%). By using cannabis that is high in CBD, but low in - Δ-9-THC, it is hypothesized that some of these effects can be avoid, while maximizing the therapeutic effects, if any.
Detailed description
The goal of this study is to perform a double-blind, placebo-controlled study to investigate the efficacy of cannabis, compared to placebo, in medically ill participants seeking relief symptoms such as pain, nausea, and vomiting. Participants who meet criteria for severe conditions will be referred from their clinicians . Cannabis that has a high concentration of cannabidiol, which is a cannabinoid that does not change perception or produce intoxication, and low in Δ-9-THC will be used. In this way, the hope is to maximize the benefit of cannabis, while lowering the possible side effects of cannabis in medically ill participants.
The overall goal of this study is to compare active high cannabidiol (CBD)/ low (-)-trans-Δ9- tetrahydrocannabinol (THC) cannabis vs placebo cannabis in patients with serious medical disorders. Participants will be referred from clinicians and will come to the laboratory daily (3-5 times weekly) for cannabis (15.76% CBD; 3.11% Δ-9-THC) vs placebo (0.0% CBD/ 0.01% Δ-9-THC). The cannabis will be vaporized or smoked as a cannabis cigarette. The participants can choose which option they prefer. The cross-over design will be used where participants receive 2 weeks of active cannabis vs two weeks of placebo in counterbalanced order, with participants blinded to the condition. The outcome measures primarily include measures of pain, with secondary measures of mood, nausea/appetite, quality of life, and the both the potentially positive and negative subjective effects of cannabis (e.g., high, mellow, anxious, paranoid).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 Marijuana Research Laboratory 3-5 weekdays per week for 4 weeks to be administered 1-2 Smoked Cannabis High CBD/low THC cigarettes (15.76% CBD; 3.11% THC) over the course of a 2-3 hour session. |
| Smoked Placebo Cannabis Low CBD/low THC | Placebo comparator | Drug: Smoked Placebo Cannabis Low CBD/low THCParticipants will visit the Marijuana Research Laboratory 3-5 weekdays per week for 4 weeks to be administered 1-2 cannabis cigarettes (0.01% THC; 0.00% CBD) over the course of a 2-3 hour session. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- One of the medical diagnoses (cancer, amyotrophic lateral sclerosis, Parkinson's disease, spinal cord injury, neuropathy, and phantom limb pain, thalamic pain, pain related to injury of nerve plexus/plexi, and neuropathic facial pain), with reports of pain (at least 3 on item 3 on the 9 item Brief Pain Inventory)that remains despite their current medical treatment.
- Age 21-60
- Able to give informed consent, and comply with study procedures
- Experience inhaling substances.
Key exclusion criteria (6 listed)
- Meet DSM-V criteria for current major psychiatric illness, such as bipolar disorder, major depression, active suicidality, 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 THCAlso: cannabis cigarettes (15.76% CBD; 3.11% THC)Participants will visit the Marijuana Research Laboratory 3-5 weekdays per week for 4 weeks to be administered 1-2 cannabis cigarettes (15.76% CBD; 3.11% THC) over the course of a 2-3 hour session. | Drug | Smoked Cannabis High CBD/low THC |
| Smoked Placebo Cannabis Low CBD/low THCAlso: cannabis cigarettes (0.01% THC; 0.00% CBD)Participants will visit the Marijuana Research Laboratory 3-5 weekdays per week for 4 weeks to be administered 1-2 cannabis cigarettes (0.01% THC; 0.00% CBD) over the course of a 2-3 hour session. | Drug | Smoked Placebo Cannabis Low CBD/low THC |
Primary outcome
Change in pain ratings using the McGill Pain Questionnaire
Time frame: 4 weeks
Participants will be asked to rate their pain over the 4 weeks of receiving active cannabis vs placebo.
Change in sickness-related impairment using the Sickness Impact Profile
Time frame: 4 weeks
Participants will be asked to rate physical symptoms for the 4 weeks of the study.
changes in physical and emotional well being using the RAND-36 item medical outcomes survey, a health-related quality of life survey instrument
Time frame: 4 weeks
RAND-36 item medical outcomes survey taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.
Changes in symptoms of pain using the 9 item Brief Pain Inventory
Time frame: 4 weeks
11 secondary outcomes
Change in cognitive status using the Short Portable Mental Status Questionnaire (SPMSQ)
Time frame: 4 weeks
Change in symptom prevalence, characteristics and degree of stress using the Memorial Symptom Assessment Scale (MSAS)
Time frame: 4 weeks
Change in the psychological state and psychological well being using the Mental Health Inventory-5 (MHI-5)
Time frame: 4 weeks
Changes in quality of life using the Multidimensional Index of Life Quality (MILQ) Questionnaire
Time frame: 4 weeks
Changes in quality of life using the McGill Quality of Life Questionnaire
Time frame: 4 weeks
Change in symptoms of pain, mood and appetite using the Edmonton Symptom Assessment System (ESAS)
Time frame: 4 weeks
Memorial Symptom Assessment Scale (MSAS)
Time frame: 4 weeks
Change in mood using the Hamilton Depression Rating Scale
Time frame: 4 weeks
Change in mood Hamilton Anxiety Rating Scale
Time frame: 4 weeks
Change in mood using the Montgomery-Asberg Depression Rating Scale
Time frame: 4 weeks
Change in mood and quality of life using the Columbia Suicide Severity Rating Scale
Time frame: 4 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
New York Sate Psychiatric Institute/ Columbia University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Smoked Cannabis High CBD/low THC in people with Chronic Pain, 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: 4 weeks). The study lists 4 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.