Investigation of Cannabis for Chronic Pain and Palliative Care
Primary Purpose
Chronic Pain
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Withdrawn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 Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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 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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Changes in symptoms of pain using the 9 item Brief Pain Inventory
Secondary Outcome Measures
Change in cognitive status using the Short Portable Mental Status Questionnaire (SPMSQ)
Change in symptom prevalence, characteristics and degree of stress using the Memorial Symptom Assessment Scale (MSAS)
Change in the psychological state and psychological well being using the Mental Health Inventory-5 (MHI-5)
Changes in quality of life using the Multidimensional Index of Life Quality (MILQ) Questionnaire
Changes in quality of life using the McGill Quality of Life Questionnaire
Change in symptoms of pain, mood and appetite using the Edmonton Symptom Assessment System (ESAS)
Memorial Symptom Assessment Scale (MSAS)
Change in mood using the Hamilton Depression Rating Scale
Change in mood Hamilton Anxiety Rating Scale
Change in mood using the Montgomery-Asberg Depression Rating Scale
Change in mood and quality of life using the Columbia Suicide Severity Rating Scale
Full Information
NCT ID
NCT02683018
First Posted
February 11, 2016
Last Updated
October 28, 2021
Sponsor
New York State Psychiatric Institute
1. Study Identification
Unique Protocol Identification Number
NCT02683018
Brief Title
Investigation of Cannabis for Chronic Pain and Palliative Care
Official Title
Investigation of Cannabis for Chronic Pain and Palliative Care
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 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover 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 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.
Arm Title
Smoked Placebo Cannabis Low CBD/low THC
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Smoked Cannabis High CBD/low THC
Other Intervention Name(s)
cannabis cigarettes (15.76% CBD; 3.11% THC)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Smoked Placebo Cannabis Low CBD/low THC
Other Intervention Name(s)
cannabis cigarettes (0.01% THC; 0.00% CBD)
Intervention Description
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.
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 4 weeks of receiving active cannabis vs placebo.
Time Frame
4 weeks
Title
Change in sickness-related impairment using the Sickness Impact Profile
Description
Participants will be asked to rate physical symptoms for the 4 weeks of the study.
Time Frame
4 weeks
Title
changes in physical and emotional well being using the RAND-36 item medical outcomes survey, a health-related quality of life survey instrument
Description
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.
Time Frame
4 weeks
Title
Changes in symptoms of pain using the 9 item Brief Pain Inventory
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in cognitive status using the Short Portable Mental Status Questionnaire (SPMSQ)
Time Frame
4 weeks
Title
Change in symptom prevalence, characteristics and degree of stress using the Memorial Symptom Assessment Scale (MSAS)
Time Frame
4 weeks
Title
Change in the psychological state and psychological well being using the Mental Health Inventory-5 (MHI-5)
Time Frame
4 weeks
Title
Changes in quality of life using the Multidimensional Index of Life Quality (MILQ) Questionnaire
Time Frame
4 weeks
Title
Changes in quality of life using the McGill Quality of Life Questionnaire
Time Frame
4 weeks
Title
Change in symptoms of pain, mood and appetite using the Edmonton Symptom Assessment System (ESAS)
Time Frame
4 weeks
Title
Memorial Symptom Assessment Scale (MSAS)
Time Frame
4 weeks
Title
Change in mood using the Hamilton Depression Rating Scale
Time Frame
4 weeks
Title
Change in mood Hamilton Anxiety Rating Scale
Time Frame
4 weeks
Title
Change in mood using the Montgomery-Asberg Depression Rating Scale
Time Frame
4 weeks
Title
Change in mood and quality of life using the Columbia Suicide Severity Rating Scale
Time Frame
4 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:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Martinez, MD
Organizational Affiliation
New York Sate Psychiatric Institute/ Columbia University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Investigation of Cannabis for Chronic Pain and Palliative Care
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