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CAMS Study

CAMS Study. A Multicentre Randomised Controlled Trial of Cannabinoids in Multiple Sclerosis. Principle Investigators Dr John Zajicek Dr Alan Thompson Andrew Nunn Hilary Sanders. Background - Multiple Sclerosis. Background - MS.

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CAMS Study

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  1. CAMS Study A Multicentre Randomised Controlled Trial of Cannabinoids in Multiple Sclerosis Principle Investigators Dr John Zajicek Dr Alan Thompson Andrew Nunn Hilary Sanders

  2. Background - Multiple Sclerosis

  3. Background - MS • 90% of patients with Multiple Sclerosis (MS) will experience symptoms of muscle spasticity and spasms. • Current therapies for spasticity include baclofen, tizanidine, dantrolene and diazepam. • All of these have significant side effects and limited efficacy.

  4. Background - MS • Cannabis - widespread anecdotal reports of beneficial effects on • spasticity • tremor • urinary disturbance • pain.

  5. Background - MS • Only two previous attempts at randomised double blind controlled studies of cannabinoids in total of 22 patients. • Petro and Ellenberger, 1981 • 9 patients, 3 days. • THC, double blinded crossover design • significant reduction in spasticity score.

  6. Background - MS • Ungerleider et al, 1988 • 13 patients, up to 6 weeks • THC, double blinded crossover design • significant reduction in patient rating of spasticity. • Thus probably beneficial effect, but too small to generalise.

  7. Background - Cannabis

  8. Background - Cannabis • Cannabis sativa - “Cultivated Cannabis” • Many uses • Rope • Canvas • Clothing • Paper • Medicinal

  9. Background - Cannabis • Medicinal use for over 2000 years. • First in the far east. • Mentioned in western medical textbooks from the 13th century onwards. • The peak in its use was in the 19th century.

  10. Background - Cannabis • Indications in 19th century. • Dysmenorrhoea

  11. Background - Cannabis • Other Indications. • Pain • Cramps • Fever • Vomiting • Asthma • Epilepsy.

  12. Background - Cannabis • Also psychoactive properties. • Recreational use.

  13. Background - Cannabis • Fell out of use in early 20th century • concern over its recreational use • inconsistency in its preparation and absorption • poor storage stability • Formally banned in 1928 • Remained prescribable until 1971.

  14. Background - Cannabis • Over 60 aromatic hydrocarbon compounds known as cannabinoids. • Pharmacological effects mediated through cannabinoid receptors • CB1 receptors are found widely in the nervous system • CB2 receptors predominantly on B lymphocytes.

  15. Background - Cannabis • THC - most important active cannabinoid. • Available synthetically. • Prescribable for nausea as nabilone.

  16. Background - Cannabis • 1998 - House of Lords Select Committee report - “Cannabis, the scientific and medical evidence”. • Positive about medicinal use. • Advised further research before rescheduling of the drug.

  17. Trial Design

  18. Trial Design • Multicentre randomised controlled trial. • Comparing THC, cannabis oil and placebo. • Coordinated from Plymouth • Derriford will recruit approximately 100 patients • 560 patients distributed across about 20 other centres nationwide.

  19. Trial Design - Centres

  20. Trial Design • Two Phases • Weeks 1-16 • All patients on drug • Seven clinic visits • Weeks 17-52 • Patient chooses whether to continue drug • Three clinic visits

  21. Trial Design

  22. Primary Outcome Measures • Ashworth Scale • 5 grade assessment of spasticity on clinical examination. • Rather coarse steps. • Rather subjective. • Reasonable inter- and intra- rater reliability.

  23. Secondary Outcome Measures • Timed 10m walk • Rivermead Mobility Index • UK Neurological Disability Status Scale • GHQ-30 (a quality of life questionnaire) • Barthel Index (a measure of activities of daily living) • 9 further category rating scales.

  24. Blinding • Risk of unblinding of patient due to widely known side effects. • Two study personnel. • Treating physician • Assessor (physician or physiotherapist) • Degree of unblinding assessed at the end of the trial.

  25. Results • Recruitment will start at beginning of 2001. • Recruitment expected to last about 1 year. • Results available 1 year after recruitment closes. • Government has indicated that a successful trial may lead to rescheduling of cannabis.

  26. Further Information • References & general information: • www.cannabis-trial.plymouth.ac.uk • email: • cannabis-trial@plymouth.ac.uk • Telephone: • 01752 315250

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