NEWS HIGHLIGHTS
Published Studies Related to Cesamet (Nabilone)
Nabilone produces marked impairments to cognitive function and changes in subjective state in healthy volunteers. [2010.11]
This was a double-blind, randomised, placebo-controlled, crossover study of the acute cognitive and subjective effects of nabilone 1-3 mg in healthy male volunteers. The Cognitive Drug Research computerised system (CDR system) was used to assess changes in attention, working and episodic memory...
A randomized, double-blinded, crossover pilot study assessing the effect of nabilone on spasticity in persons with spinal cord injury. [2010.05]
OBJECTIVES: To determine whether nabilone, a synthetic cannabinoid, alleviates spasticity in people with spinal cord injury (SCI)... CONCLUSIONS: Nabilone may be beneficial to reduce spasticity in people with SCI. We recommend a larger trial with a more prolonged treatment period and an option to slowly increase the dosage further.
The effects of nabilone on sleep in fibromyalgia: results of a randomized controlled trial. [2010.02.01]
BACKGROUND: Sleep disorders affect many patients with chronic pain conditions. Cannabis has been reported by several patient populations to help sleep. We evaluated the safety and efficacy of nabilone, a synthetic cannabinoid, on sleep disturbance in fibromyalgia (FM), a disease characterized by widespread chronic pain and insomnia... CONCLUSIONS: Nabilone is effective in improving sleep in patients with FM and is well tolerated. Low-dose nabilone given once daily at bedtime may be considered as an alternative to amitriptyline. Longer trials are needed to determine the duration of effect and to characterize long-term safety.
A pilot study using nabilone for symptomatic treatment in Huntington's disease. [2009.11.15]
Pilot study of nabilone in Huntington's disease (HD).Larger longer RCT of nabilone in HD is feasible and warranted.
Analgesic and antihyperalgesic effects of nabilone on experimental heat pain. [2008.04]
CONCLUSIONS: Nabilone failed to produce analgesic effects and it did not interact with descending pain inhibitory systems. However, we found that a single 1 mg dose of nabilone reduced temporal summation for women but not men. Although a titration regime and a larger sample of subjects might have provided more robust effects, these preliminary results suggest that nabilone appears effective at relieving hyperalgesic responses in women. Possible neurobiological mechanisms and clinical implications are further discussed.
Clinical Trials Related to Cesamet (Nabilone)
Efficacy Study of Nabilone in the Treatment of Diabetic Peripheral Neuropathic Pain [Recruiting]
Neuropathic pain occurs as a result of damage or disease of the peripheral or central
nervous system. Regardless of its cause, neuropathic pain (NeP) leads to a characteristic
clinical picture characterized by ongoing pain with steady or dysesthetic pain, such as
burning or aching, and paroxysmal pain such as shooting or stabbing. In conditions such as
diabetic neuropathy, changes in the membrane-bound proteins that form ion channels may alter
the electrical properties of the injured neuron, called remodeling. The net effect of
membrane remodeling is greater excitability of neurons, leading to a tendency towards action
potential generation and propagation in injured primary sensory neurons which occurs in the
context of nerve injury and disease. Over the past decade, a new endogenous cannabinoid
receptor-mediated system within the nervous system and upon immune-mediated cells has been
described. The cannabinoid receptor system consists of two receptors, CB1 and CB2
receptors, as well as endogenously produced endocannabinoids which agonize these receptors.
This is a multicenter trial amongst Western Canadian sites to compare the efficacy of
nabilone versus placebo in treating patients with chronic neuropathic pain (NeP) due to
diabetic peripheral neuropathy (DPN).
A one-week screening period will occur, during which pain scores and sleep scores will be
tabulated. Following screening, a 4-week period of single blind treatment with flexible
dosing of nabilone at 0. 5 - 4 mg/day will initiate. All subjects will begin with nabilone
therapy of 1 mg daily for a minimum of 4 days, with the dose of the study medication
assessed and adjusted either upwards or downwards as needed to balance efficacy for pain
control with tolerability of possible side effects. All subjects who experience at least a
30% reduction in their weekly mean pain score during the single blind flexible dosing phase
will be considered a responder, and will be further continued in the study. During the
double-blind portion of the study, subjects randomized to nabilone will continue on the dose
of nabilone achieved at the completion of the single-blind phase, and this dose will be
maintained throughout the double-blind phase. Subjects randomized to placebo will receive 1
mg of nabilone daily for one week, followed by 4 consecutive weeks of placebo. This dose of
nabilone will permit a tapering for those subjects achieving a higher daily dose of nabilone
during the single-blind phase, or will maintain those who were taking only 1 mg per day in
the single-blind phase, preventing an abrupt termination of treatment in subjects who are
randomized into the placebo portion of the study.
Nabilone for Cannabis Dependence: A Pilot Study [Recruiting]
Cannabis use disorders are an important public health problem in the United States, but
there are no effective medications available to treat these disorders. The investigators
intend to test a medication with interesting properties, nabilone, as a treatment for
cannabis dependence and to study the relationship of this treatment with the brain using
functional MRI brain scans. Nabilone and marijuana have similar effects upon behaviors and
the human body, suggesting that nabilone may decrease cannabis withdrawal symptoms while
allowing treatment-seeking patients to benefit from behavioral treatments when they are
trying to stop using cannabis. The investigators propose to assess the relationship of
nabilone, when added to behavioral treatment, on cannabis use patterns in cannabis-dependent
patients. The investigators also aim to determine the effects of nabilone on performance on
neuropsychological tests and to assess the correlation of neuropsychological performance to
brain changes using functional MRI brain scans. The investigators hypothesize that patients
receiving nabilone will reduce their use of cannabis more than patients receiving placebo
during this 10-week treatment trial.
Efficacy and Safety Evaluation of Nabilone as Adjunctive Therapy to Gabapentin for the Management of Neuropathic Pain in Multiple Sclerosis [Recruiting]
The purpose of this study is to determine whether nabilone (Cesamet) when used as an
adjunctive agent with gabapentin (Neurontin) provides significantly improved pain relief
over gabapentin alone for the management of neuropathic pain in MS.
A Phase IV Trial of Cesametâ„¢ Given With Standard Antiemetic Therapy for Chemotherapy-Induced Nausea and Vomiting [Terminated]
This is a Phase IV, open-label, sequential treatment study in patients who are receiving
standard chemotherapy for non-small cell lung cancer, breast cancer, or colorectal cancer.
(See Section 4. 2.1 for eligible treatment regimens.) The study will take place during the
first 2 cycles of chemotherapy.
Phase 1 of study:
Prior to the first dose of chemotherapy, patients will be instructed on how to complete their
patient diary, which will include a Visual Analogue Scale (VAS) for nausea and a VAS for
pain. In addition, the diary will include a section to list their current pain medications
(see Sample Patient Diary in Appendix I). After being instructed, patients will complete the
VAS for nausea and for pain, as well as listing their current pain medications. Patients will
then receive chemotherapy on Day 1 of Cycle 1 in combination with the pre-defined standard
serotonin antagonist/corticosteroid regimen.
Beginning on Day 2, the diary will be completed for 5 consecutive days (Days 2-6). Each day,
patients will complete a diary entry pertaining to the preceding 24 hours. The entry will
include the number and time of any emetic episodes, any antiemetic rescue medications used,
VAS for nausea, and side effects of treatment. On the last day of the diary (Day 6), the
entry will include the above daily parameters but will also include a VAS for pain. In
addition, the patient will complete a diary entry pertaining to the 5-day study period that
will include pain medications used. Patients will also complete the Functional Living Index - Cancer (FLIC) questionnaire (see Sample Function Living Index - Cancer questionnaire in
Appendix II).
Patients who either have at least one vomiting episode or at least one report of significant
nausea (VAS > 25 mm) during the first 5-day study period will be eligible for the second
phase of the study.
Phase 2 of the study:
Patients in the second phase will receive a second cycle of the same chemotherapy. The
antiemetic regimen for the second cycle will be the same serotonin antagonist/corticosteroid
regimen as they received in Cycle 1, with the addition of Cesamet.
For Cycle 2 of treatment, patients will receive Cesamet 1 mg the night before chemotherapy is
to be administered. On the day of chemotherapy (Day 1 of Cycle 2), Cesamet 2 mg will be given
1 to 3 hours before the chemotherapy is administered, in addition to the same serotonin
antagonist/corticosteroid regimen as they received in Cycle 1. Patients will receive an
additional dose of Cesamet 2 mg the evening of Day 1.
Patients will receive Cesamet 2 mg BID on Days 2-5. Patients will complete the same 5-day
diary and FLIC questionnaire as they did in Cycle 1. Beneficial effects of Cesamet will be
estimated by comparing the results of the second cycle to the results of the first cycle.
Patients will be evaluated for the first 2 cycles of chemotherapy only.
Use of the Cannabinoid Nabilone for the Promotion of Sleep in Chronic, Non-Malignant Pain Patients [Recruiting]
Sleep disturbance is perhaps one of the most prevalent complaints of patients with
long-standing painful conditions. Nabilone is a medication that is approved by Health
Canada as an anti-emetic (prevent vomiting) for patients undergoing chemotherapy. Nabilone,
due to its sleep promoting properties, is sometimes prescribed by physicians to pain
patients to help improve their sleep. However, there is no direct research evidence to
either support or refute this practice. This study will investigate if nabilone is
effective in improving sleep in insomnia and pain patients.
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