CAMS (Cannabinoids in Multiple Sclerosis)
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A multiple randomised controlled trial of cannabinoids on spasticity in multiple sclerosis (MS)

Authors Zajicek, John
Registry of Trials ISRCTN registry
Year 2000
Links DOI isrctn.com
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INTERVENTION: Patients will be randomly assigned to one of four regimens in the ratio 2:1:2:1, as follows: 1. THC (Marinol) (maximum total daily dose 0.25 mg/kg in equal doses, given as 2.5 mg THC capsules) 2. Placebo capsules (containing oil vehicle) matched to appearance of THC 3. Natural cannabis oil (Cannador) containing the same dose of THC, made up to GMP standard 4. Placebo capsules (containing oil vehicle) matched to appearance of the cannabis capsules CONDITION: Multiple sclerosis ; Nervous System Diseases ; Multiple sclerosis PRIMARY OUTCOME: Changes in Ashworth score SECONDARY OUTCOME: Not provided at time of registration INCLUSION CRITERIA: 1. Clinically definite or laboratory supported MS aged 18‐64 years inclusive 2. Significant spasticity in at least 2 lower limb muscle groups (Ashworth score of 2 or more, in two or more muscle groups, eg left foot plantar flexion & left knee & right knee flexors, etc) 3. Stable disease for previous 6 months in the opinion of the treating physician 4. Antispasticity medication and physiotherapy stabilised for the last 30 days 5. Patients may be ambulatory or not

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The psychological effects of cannabis in MS: impact on cognition, pain, mood and fatigue [abstract]

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Journal Mult Scler ECTRIMS
Year 2003
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There is increasing interest in the therapeutic potential of cannabinoids in multiple sclerosis (MS), but also reservations about their effects on psychological variables, which are largely unexplored. Studies of community samples of cannabis users indicate fairly subtle cognitive changes, even after many years of significant use. However, there are suggestions that cannabinoids may have greater effects in vulnerable groups. The research question addressed by this substudy of the cannabis (CAMS) trial was: do cannabinoids in an MS population affect memory and attention, fatigue, pain or mood? A subset of patients was recruited from the 660 patients in the MRC-funded CAMS study, a double-blind randomized controlled trial of cannabinoids for spasticity in MS. Patients received either THC, natural cannabis oil with equivalent THC, or placebo (all via capsules containing oil), for thirteen weeks. Eighty-nine patients from the two largest centers completed a psychological battery before, during and after the medication period. The battery assessed cognition, focusing on memory and attention (California Verbal Learning Test, Paced Auditory Serial Addition Task, Digit Span, Digit Symbol, and the self report Dysexecutive Questionnaire); fatigue (Fatigue Impact Scale); pain (McGill Pain Questionnaire 78 adjectives); and mood (Chicago Multiscale Depression Inventory, Hospital Anxiety and Depression Scale). There were also visual analogue scaled for cognition, fatigue, pain and mood to help validate the standardized measures in a cannabinoid-medicated MS population. Initial findings from preliminary statistical analysis will be given and their likely impact on potential use of cannabis in MS will be discussed.

Primary study

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Cannabinoids for treatment of spasticity and other symptoms related to multiple sclerosis (CAMS study): multicentre randomised placebo-controlled trial.

Journal Lancet
Year 2003
Links Pubmed DOI
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<b>BACKGROUND: </b>Multiple sclerosis is associated with muscle stiffness, spasms, pain, and tremor. Much anecdotal evidence suggests that cannabinoids could help these symptoms. Our aim was to test the notion that cannabinoids have a beneficial effect on spasticity and other symptoms related to multiple sclerosis.<b>METHODS: </b>We did a randomised, placebo-controlled trial, to which we enrolled 667 patients with stable multiple sclerosis and muscle spasticity. 630 participants were treated at 33 UK centres with oral cannabis extract (n=211), Delta9-tetrahydrocannabinol (Delta9-THC; n=206), or placebo (n=213). Trial duration was 15 weeks. Our primary outcome measure was change in overall spasticity scores, using the Ashworth scale. Analysis was by intention to treat.<b>FINDINGS: </b>611 of 630 patients were followed up for the primary endpoint. We noted no treatment effect of cannabinoids on the primary outcome (p=0.40). The estimated difference in mean reduction in total Ashworth score for participants taking cannabis extract compared with placebo was 0.32 (95% CI -1.04 to 1.67), and for those taking Delta9-THC versus placebo it was 0.94 (-0.44 to 2.31). There was evidence of a treatment effect on patient-reported spasticity and pain (p=0.003), with improvement in spasticity reported in 61% (n=121, 95% CI 54.6-68.2), 60% (n=108, 52.5-66.8), and 46% (n=91, 39.0-52.9) of participants on cannabis extract, Delta9-THC, and placebo, respectively.<b>INTERPRETATION: </b>Treatment with cannabinoids did not have a beneficial effect on spasticity when assessed with the Ashworth scale. However, though there was a degree of unmasking among the patients in the active treatment groups, objective improvement in mobility and patients' opinion of an improvement in pain suggest cannabinoids might be clinically useful.

Primary study

Unclassified

Cannabinoids do not reduce objective measurements in muscle spasticity, but people with multiple sclerosis perceive some benefit

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Authors Grotenhermen F
Journal Evidence-Based Healthcare
Year 2004
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Primary study

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Cannabinoid influence on cytokine profile in multiple sclerosis.

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Journal Clinical and experimental immunology
Year 2005
Links Pubmed DOI PubMed Central
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Cannabinoids have been suggested as possessing immunomodulatory properties, and cannabinoid receptors are present on leucocytes. Clinically, there is some evidence that cannabinoids may be therapeutically useful in treating multiple sclerosis, which is generally believed to be an autoimmune condition. This paper reports data derived from the Cannabinoids in MS (CAMS) study, which was the largest randomized controlled trial yet conducted to evaluate the therapeutic efficacy of cannabinoids. We found no evidence for cannabinoid influence on serum levels of interferon (IFN)-gamma, interleukin (IL)-10, IL-12 or C-reactive protein as measured using enzyme-linked immunosorbent assay (ELISA), in comparison to control values. Mitogenic stimulation experiments also failed to demonstrate any significant reduction in percentage of CD3+, IFN-gamma producing cells after exposure to cannabinoids in vivo, although numbers were small. Further work is needed to establish the functional significance of cannabinoid receptors on immune cells.

Primary study

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Cannabinoids in multiple sclerosis (CAMS) study: safety and efficacy data for 12 months follow up.

Journal Journal of neurology, neurosurgery, and psychiatry
Year 2005
Links Pubmed DOI PubMed Central
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<b>OBJECTIVE: </b>To test the effectiveness and long term safety of cannabinoids in multiple sclerosis (MS), in a follow up to the main Cannabinoids in Multiple Sclerosis (CAMS) study.<b>METHODS: </b>In total, 630 patients with stable MS with muscle spasticity from 33 UK centres were randomised to receive oral Delta(9)-tetrahydrocannabinol (Delta(9)-THC), cannabis extract, or placebo in the main 15 week CAMS study. The primary outcome was change in the Ashworth spasticity scale. Secondary outcomes were the Rivermead Mobility Index, timed 10 metre walk, UK Neurological Disability Score, postal Barthel Index, General Health Questionnaire-30, and a series of nine category rating scales. Following the main study, patients were invited to continue medication, double blinded, for up to 12 months in the follow up study reported here.<b>RESULTS: </b>Intention to treat analysis of data from the 80% of patients followed up for 12 months showed evidence of a small treatment effect on muscle spasticity as measured by change in Ashworth score from baseline to 12 months (Delta(9)-THC mean reduction 1.82 (n = 154, 95% confidence interval (CI) 0.53 to 3.12), cannabis extract 0.10 (n = 172, 95% CI -0.99 to 1.19), placebo -0.23 (n = 176, 95% CI -1.41 to 0.94); p = 0.04 unadjusted for ambulatory status and centre, p = 0.01 adjusted). There was suggestive evidence for treatment effects of Delta(9)-THC on some aspects of disability. There were no major safety concerns. Overall, patients felt that these drugs were helpful in treating their disease.<b>CONCLUSIONS: </b>These data provide limited evidence for a longer term treatment effect of cannabinoids. A long term placebo controlled study is now needed to establish whether cannabinoids may have a role beyond symptom amelioration in MS.

Primary study

Unclassified

The effect of cannabis on urge incontinence in patients with multiple sclerosis: a multicentre, randomised placebo-controlled trial (CAMS-LUTS).

Journal International urogynecology journal and pelvic floor dysfunction
Year 2006
Links Pubmed DOI
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OBJECTIVE: To test whether cannabinoids reduce urge incontinence episodes without affecting voiding in patients with multiple sclerosis. This was part of the multicentre trial of the Cannabinoids in Multiple Sclerosis (CAMS) study. SUBJECTS AND METHODS: The CAMS study randomised 630 patients to receive oral administration of cannabis extract, Delta(9)-tetrahydrocannabinol (THC) or matched placebo. For this substudy subjects completed incontinence diaries. RESULTS: All three groups showed a significant reduction, p<0.01, in adjusted episode rate (i.e. correcting for baseline imbalance) from baseline to the end of treatment: cannabis extract, 38%; THC, 33%; and placebo, 18%. Both active treatments showed significant effects over placebo (cannabis extract, p=0.005; THC, p=0.039). CONCLUSION: The findings are suggestive of a clinical effect of cannabis on incontinence episodes in patients with MS. This is in contrast to the negative finding of the CAMS study, where no difference was seen in the primary outcome of spasticity.