Cesamet┬« (nabilone) is a synthetic cannabinoid for oral administration. Nabilone as a raw material occurs as a white to off-white polymorphic crystalline powder. In aqueous media, the solubility of nabilone is less than 0.5 mg/L, with pH values ranging from 1.2 to 7.0.
Cesamet capsules are indicated for the treatment of the nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. This restriction is required because a substantial proportion of any group of patients treated with Cesamet can be expected to experience disturbing psychotomimetic reactions not observed with other antiemetic agents.
Because of its potential to alter the mental state, Cesamet is intended for use under circumstances that permit close supervision of the patient by a responsible individual particularly during initial use of Cesamet and during dose adjustments.
Cesamet contains nabilone, which is controlled in Schedule II of the Controlled Substances Act. Schedule II substances have a high potential for abuse. Prescriptions for Cesamet should be limited to the amount necessary for a single cycle of chemotherapy (i.e., a few days).
Cesamet capsules are not intended to be used on as needed basis or as a first antiemetic product prescribed for a patient.
As with all controlled drugs, prescribers should monitor patients receiving nabilone for signs of excessive use, abuse and misuse. Patients who may be at increased risk for substance abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse) or mental illness.
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)
Study of Prevention of Postoperative Nausea and Vomiting Using Cesamet [Recruiting]
Untreated, one third of patients undergoing general anesthesia will have postoperative
nausea, vomiting, or both.
Patients often rate postoperative nausea and vomiting (PONV) as worse than postoperative
pain. PONV increases the risk of aspiration and has been associated with suture dehiscence,
esophageal rupture, subcutaneous emphysema, and bilateral pneumothoraxes. PONV frequently
delays discharge, and is the leading cause of unexpected hospital admission after planned
Nabilone (Cesamet«) is a synthetic cannabinoid developed in the 1970s which is a potent CB1
agonist. The use of nabilone in preventing nausea and vomiting in patients receiving
chemotherapy has been thoroughly investigated. Results from clinical studies demonstrated
the efficacy, safety, and tolerability of Cesamet in this population. There has been success
in the past translating treatments for chemotherapy-induced nausea and vomiting (ie. 5-HT
receptor agonists including Ondansetron and Granisetron) to use in the perioperative
Only one RCT has studied the use of nabilone for the reduction of PONV. Published in 1995,
this study compared the administration of either Cesamet 2 mg or metoclopramide 10 mg given
90 minutes before the operation in patients scheduled for elective hysterectomy in 60 women.
This study failed to show any significant difference between groups. There are several
limitations to this study including a poorly optimized dosing regimen, a small sample size,
and a comparison group lacking clinical generalizability.
This study will investigate the use Cesamet vs Placebo, in addition to the regular
antiemetic treatment which patients receive at the discretion of the managing
anesthesiologist, for the prevention of PONV. The study group will include patients
undergoing general anesthesia for elective ambulatory surgery with at least 3 risk factors
(>60% risk) for the development of PONV.
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 [Active, not 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 [Completed]
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 Trial Assessing the Effect of Nabilone on Pain and Quality of Life in Patients With Fibromyalgia [Completed]
The purpose of the study is to determine whether or not the drug Nabilone significantly
reduces pain and improves quality of life in patients with fibromyalgia.
Page last updated: 2011-12-09