Cannabis for Inflammatory Bowel Disease

NCT01040910 | Unknown Phase 1

• 1 other identifier: cannabis1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Background: The marijuana plant Cannabis has been used for centuries in the medicinal treatment of many disorders and is still the subject of medical research and public debate. Cannabinoids have been purported to alleviate a variety of neurological conditions such as MS-related symptoms including spasticity, pain, tremor and bladder dysfunction. Other neurological conditions like chronic intractable pain, dystonic movement disorders and Tourette's Syndrome were all reported to be alleviated by cannabis use. Cannabis has been used to treat anorexia in AIDS and cancer patients. In gastroenterology cannabis has been used to treat symptoms and diseases including anorexia, emesis, abdominal pain, gastroenteritis, diarrhoea, intestinal inflammation and diabetic gastroparesis. Cannabinoids have also a profound anti inflammatory effect, mainly through the CB2 receptor. Cell mediated immunity may be impaired in chronic marijuana users. And a potent anti-inflammatory effect of cannabis was observed in rats . Studying the functional roles of the endocannabinoid system in immune modulation reveals that there are no major immune events which do not involve the endocannabinoid system. Cannabinoids shift the balance of pro-inflammatory cytokines and anti-inflammatory cytokines towards the T-helper cell type 2 profiles (Th2 phenotype), and suppress cell-mediated immunity whereas humoral immunity may be enhanced. They are therefore used for various inflammatory conditions including rheumatoid arthritis and asthma. In a mouse model of colitis cannabinoids were found to ameliorate inflammation and there are many anecdotal reports about the effect of cannabis in inflammatory bowel disease. However, there are no methodical reports of the effect of cannabis on inflammatory bowel disease. The aim of the proposed study is to examine in a double blind placebo controlled fashion the effect of smoking cannabis on disease activity in patients with IBD.

Conditions

Crohn's Disease; Ulcerative Colitis

Keywords

cannabis; Crohn's disease; Ulcerative colitis; IBD

Outcome Measures

Primary Outcomes (1)

• reduction of CDAI by 70 points

  8 weeks

Secondary Outcomes (3)

• adverse events due to cannabis smoking

  8 weeks

• change in quality of life before and at the end of study

  8 weeks

• change in IL-10. IL-2. TGF beta

  week 0 and week 8

Study Arms (2)

cannabis smoking for IBD

ACTIVE COMPARATOR

patients with active disease receiving active cannabis for smoking

Drug: smoking of cannabis

patients smoking non active cannabis

PLACEBO COMPARATOR

patients with active disease receiving cannabis from which active ingredients have been chemically removed

Drug: smoking cigarettes with placebo

Interventions

smoking of cannabis DRUG

smoking of cannabis, 2 cigarettes a day, equivalent to about 50 mg THC

cannabis smoking for IBD

smoking cigarettes with placebo DRUG

smoking cigarettes with cannabis that was chemically treated so that most active ingredients were removed

patients smoking non active cannabis

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosis IBD at least 3 months before recruitment will be eligible to the study.
• 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.
• Disease activity index of either CDAI of more then 200 in Crohn's disease or Mayo score above 3 in UC.
• Age above 20.

You may not qualify if:

• Patients with a known mental disorder
• Patients who are deemed to be at a high risk of abuse or addiction to the study drug.
• Pregnant women
• Patients who are sensitive to any of the ingredients of the study medication.
• Patients who are unable to give informed consent.
• Patients who may need surgery in the near future.

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (2)

Meir hospital

Kfar Saba, 44281, Israel

RECRUITING

Meir Medical center

Kfar Saba, Israel

RECRUITING

Related Publications (2)

• Naftali T, Bar-Lev Schleider L, Scklerovsky Benjaminov F, Konikoff FM, Matalon ST, Ringel Y. Cannabis is associated with clinical but not endoscopic remission in ulcerative colitis: A randomized controlled trial. PLoS One. 2021 Feb 11;16(2):e0246871. doi: 10.1371/journal.pone.0246871. eCollection 2021.

  PMID: 33571293 DERIVED

• Naftali T, Bar-Lev Schleider L, Dotan I, Lansky EP, Sklerovsky Benjaminov F, Konikoff FM. Cannabis induces a clinical response in patients with Crohn's disease: a prospective placebo-controlled study. Clin Gastroenterol Hepatol. 2013 Oct;11(10):1276-1280.e1. doi: 10.1016/j.cgh.2013.04.034. Epub 2013 May 4.

  PMID: 23648372 DERIVED

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Marijuana Abuse

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Fred Konikoff, professor

  Sackler school of medicine Tel Aviv university

  STUDY CHAIR

• Timna Naftali

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timna Naftali, MD

CONTACT

972-9-7472580; naftalit@clalit.org.il

Fred Konikoff, Professor

CONTACT

972-9-7472580; fred.konikoff@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 29, 2009
• First Posted: December 30, 2009
• Study Start: January 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: December 16, 2011

Record last verified: 2011-12

Locations

IL (2)