1 / 26

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.

malha
Download Presentation

CAMS Study

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  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

More Related