Investigation of Cannabis for Chronic Pain and Palliative Care
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Chronic Pain, Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 21 - 60 |
| Updated: | 4/21/2016 |
| Start Date: | March 2016 |
| End Date: | March 2021 |
| Contact: | Diana Martinez, MD |
| Email: | dm437@cumc.columbia.edu |
| Phone: | 646-774-6160 |
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.
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.
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).
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).
Inclusion Criteria:
1. 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.
2. Age 21-60
3. Able to give informed consent, and comply with study procedures
4. Experience inhaling substances.
Exclusion Criteria:
1. 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
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 substance use disorder involving marijuana or opioids.
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