Crohn's DiseasePhase 1/2NCT01040910
Cannabis for Inflammatory Bowel Disease
A Phase 1/2 study testing smoking of cannabis in people with Crohn's Disease and Ulcerative Colitis, run by Meir Medical Center at 2 sites in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis
- What is being tested?
- smoking of cannabis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesIsrael
- Study dates
- Jan 2010to Jul 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Meir hospital
Kfar Saba, 44281
Timna Naftali, MD, 972-9-7472580 ext. 1054, timna.naftali@clalit.org.il
Fred Konikoff, professor, 972-9-7472580 ext. 2525, fred.konikoff@clalit.org.il
- Recruiting
Meir Medical center
Kfar Saba
Timna Naftali, MD, +97297471054, timna.naftali@clalit.org.il
Orly Mor, +97297471017, orly.mor@clalit.org.il
About this study
Official title: A Double Blind Placebo Controlled Study of Cannabis Smoking in Inflammatory Bowel Disease
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
- Being tested
- smoking of cannabis, smoking cigarettes with placebo
- Keywords
- cannabis, Crohn's disease, Ulcerative colitis, IBD
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smoking of cannabisDrug
smoking of cannabis, 2 cigarettes a day, equivalent to about 50 mg THC
smoking cigarettes with placeboDrug
smoking cigarettes with cannabis that was chemically treated so that most active ingredients were removed
| Study group | Role | What they receive |
|---|---|---|
| cannabis smoking for IBD | Active comparator | patients with active disease receiving active cannabis for smoking Receives: 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 Receives: Drug: smoking cigarettes with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of CDAI by 70 points
Measured: 8 weeks
Secondary outcomes (3)
adverse events due to cannabis smoking
Measured: 8 weeks
change in quality of life before and at the end of study
Measured: 8 weeks
change in IL-10. IL-2. TGF beta
Measured: week 0 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionJun 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NAFTALI TIMNA, Meir Medical Center
- Investigators
- Fred Konikoff, professor, Study chair, Sackler school of medicine Tel Aviv universityTimna Naftali, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040910
- Sponsor's protocol ID
- cannabis1
- Status last verified
- Dec 2011
- First submitted
- 29 Dec 2009
- Last updated
- 16 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33571293Naftali 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.
PubMed 23648372
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Placebo Controlled Study of Cannabis Smoking in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT01040910
- Acronym / sponsor ID
- cannabis1
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Keywords
- cannabis, Crohn's disease, Ulcerative colitis, IBD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 30 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cannabis smoking for IBD | Active comparator | Drug: smoking of cannabispatients with active disease receiving active cannabis for smoking |
| patients smoking non active cannabis | Placebo comparator | Drug: smoking cigarettes with placebopatients with active disease receiving cannabis from which active ingredients have been chemically removed |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smoking of cannabissmoking of cannabis, 2 cigarettes a day, equivalent to about 50 mg THC | Drug | cannabis smoking for IBD |
| smoking cigarettes with placebosmoking cigarettes with cannabis that was chemically treated so that most active ingredients were removed | Drug | patients smoking non active cannabis |
Primary outcome
reduction of CDAI by 70 points
Time frame: 8 weeks
3 secondary outcomes
adverse events due to cannabis smoking
Time frame: 8 weeks
change in quality of life before and at the end of study
Time frame: 8 weeks
change in IL-10. IL-2. TGF beta
Time frame: week 0 and week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2011.
- Derived from this study: PubMed 33571293Naftali 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.
- Derived from this study: PubMed 23648372Naftali 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fred Konikoff, professor study chair
Sackler school of medicine Tel Aviv university
Timna Naftali principal investigator
Meir Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing smoking of cannabis in people with Crohn's Disease and Ulcerative Colitis, run by Meir Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Timna Naftali, MD (972-9-7472580 ext. 1054, naftalit@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of CDAI by 70 points (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01040910, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2011.