Clinical Studies and Case Reports

On this site you will find clinical studies with cannabis or single cannabinoids in different diseases and case reports on the use of cannabis by patients.
You may search for diseases (indications), authors, medication, study design (controlled study, open trial, case report etc.) and other criteria.




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TitleNabiximols for opioid-treated cancer patients with poorly-controlled chronic pain: a randomized, placebo-controlled, graded-dose trial.
Author(s)Portenoy RK, Ganae-Motan ED, Allende S, Yanagihara R, Shaiova L, Weinstein S, McQuade R, Wright S, Fallon MT.
Journal, Volume, IssueJ Pain. 2012 May;13(5):438-49.
Major outcome(s)Additional pain reduction following the two lower doses.
IndicationCancer;PainAbstract
MedicationCannabis

Patients with advanced cancer who have pain that responds poorly to opioid
therapy pose a clinical challenge. Nabiximols (Nabiximols is the U.S. Adopted
Name [USAN] for Sativex [GW Pharma Ltd, Wiltshire, U.K.], which does not yet have
an INN), a novel cannabinoid formulation, is undergoing investigation as add-on
therapy for this population. In a randomized, double-blind, placebo-controlled,
graded-dose study, patients with advanced cancer and opioid-refractory pain
received placebo or nabiximols at a low dose (1-4 sprays/day), medium dose (6-10
sprays/day), or high dose (11-16 sprays/day). Average pain, worst pain and sleep
disruption were measured daily during 5 weeks of treatment; other questionnaires
measured quality of life and mood. A total of 360 patients were randomized; 263
completed. There were no baseline differences across groups. The 30% responder
rate primary analysis was not significant for nabiximols versus placebo (overall
P = .59). A secondary continuous responder analysis of average daily pain from
baseline to end of study demonstrated that the proportion of patients reporting
analgesia was greater for nabiximols than placebo overall (P = .035), and
specifically in the low-dose (P = .008) and medium-dose (P = .039) groups. In the
low-dose group, results were similar for mean average pain (P = .006), mean worst
pain (P = .011), and mean sleep disruption (P = .003). Other questionnaires
showed no significant group differences. Adverse events were dose-related and
only the high-dose group compared unfavorably with placebo. This study supports
the efficacy and safety of nabiximols at the 2 lower-dose levels and provides
important dose information for future trials. PERSPECTIVE: Nabiximols, a novel
cannabinoid formulation, may be a useful add-on analgesic for patients with
opioid-refractory cancer pain. A randomized, double-blind, placebo-controlled,
graded-dose study demonstrated efficacy and safety at low and medium doses.

Route(s)Sublingual
Dose(s)
Duration (days)35
Participants263 patients with advanced cancer, who already receive opioi
DesignControlled study
Type of publicationMedical journal
Address of author(s)Department of Pain Medicine and Palliative Care, Beth Israel Medical Center, New York, New York 10003, USA. rporteno@chpnet.org
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