Cannabis for Inflammatory Bowel Disease
Paraules clau
Resum
Dates
Darrera verificació: | 11/30/2011 |
Primer enviat: | 12/28/2009 |
Inscripció estimada enviada: | 12/28/2009 |
Publicat per primera vegada: | 12/29/2009 |
Última actualització enviada: | 12/14/2011 |
Publicació de l'última actualització: | 12/15/2011 |
Data d'inici de l'estudi real: | 12/31/2009 |
Data estimada de finalització primària: | 05/31/2012 |
Data estimada de finalització de l’estudi: | 06/30/2012 |
Condició o malaltia
Intervenció / tractament
Drug: cannabis smoking for IBD
Drug: patients smoking non active cannabis
Fase
Grups de braços
Braç | Intervenció / tractament |
---|---|
Active Comparator: cannabis smoking for IBD patients with active disease receiving active cannabis for smoking | Drug: cannabis smoking for IBD smoking of cannabis, 2 cigarettes a day, equivalent to about 50 mg THC |
Placebo Comparator: patients smoking non active cannabis patients with active disease receiving cannabis from which active ingredients have been chemically removed | Drug: patients smoking non active cannabis smoking cigarettes with cannabis that was chemically treated so that most active ingredients were removed |
Criteris d'elegibilitat
Edats elegibles per estudiar | 20 Years Per a 20 Years |
Sexes elegibles per estudiar | All |
Accepta voluntaris saludables | Sí |
Criteris | Inclusion Criteria: 1. Patients with a diagnosis IBD at least 3 months before recruitment will be eligible to the study. 2. Patients with active disease who are resistant to either 5 ASA, steroids or immunomodulators, or who can not receive those drugs due to adverse reactions will be offered the possibility of smoking cannabis at a dose of two cigarettes a day which will contain either regular cannabis or pre treated cannabis as placebo. 3. Disease activity index of either CDAI of more then 200 in Crohn's disease or Mayo score above 3 in UC. 4. Age above 20. Exclusion Criteria: 1. Patients with a known mental disorder 2. Patients who are deemed to be at a high risk of abuse or addiction to the study drug. 3. Pregnant women 4. Patients who are sensitive to any of the ingredients of the study medication. 5. Patients who are unable to give informed consent. 6. Patients who may need surgery in the near future. |
Resultat
Mesures de resultats primaris
1. reduction of CDAI by 70 points [8 weeks]
Mesures de resultats secundaris
1. adverse events due to cannabis smoking [8 weeks]
2. change in quality of life before and at the end of study [8 weeks]
3. change in IL-10. IL-2. TGF beta [week 0 and week 8]