Crohn's DiseasePhase 1/2NCT01826188
Combined THC and CBD Drops for Treatment of Crohn's Disease
A Phase 1/2 study testing THC 5mg/ml and CBS 50mg/ml in people with Crohn's Disease, run by Meir Medical Center at 1 site in Israel.
Trial summary
There are many reports about efficacy of Cannabis in Crohn's disease but no controlled trials. The aim of the proposed trial is to investigate the efficacy of oil containing the cannabinoids THC and CBD given by mouth for induction of remission in Crohn's disease. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- THC 5mg/ml and CBS 50mg/ml
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2013to Jun 2018
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of Crohn's disease of at least 3 months duration, which was proved by either endoscopy or appropriate imaging study.
- Patients who have failed treatment with either 5 ASA or corticosteroids or immunomodulators or biologic agents, or steroid dependant patients, or patients who were treated by the above mentioned drugs and could not tolerate them due to side effects.
- Age 20 or older.
- Able to sign informed concent
- Active Crohn's disease with a CDAI 200 or more.
- -
Who cannot join
- Patients with a diagnosis of a mental disorder
- Patients who by the judgment of their physician are likely to develop drug addiction.
- Pregnant women or women who are intending to become pregnant
- Patients with a known cannabis allergy
- Patients who are not capable of giving an informed consent
- Patients with an impending operation due to Crohn's disease.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined THC and CBD Drops for Treatment of Crohn's Disease, a Phase II Double Blind Placebo Controlled Trial
There are many reports about efficacy of Cannabis in Crohn's disease but no controlled trials. The aim of the proposed trial is to investigate the efficacy of oil containing the cannabinoids THC and CBD given by mouth for induction of remission in Crohn's disease.
Read the detailed description
The investigators have recently published a retrospective observational study about the beneficial effect of cannabis in Crohn's disease. The investigators have also concluded a double blind placebo controlled study of Inhaled cannabis in the treatment of Crohn's disease. Both studies have shown significant symptomatic improvement of disease. However, objective parameters of inflammation were not measured. The question arises as to whether the observed improvement is merely symptomatic or due to a real change in inflammation. In addition, administration per os is a healthier option than smoking but the efficacy of oral cannabis was not investigated.
The aim of the proposed study in to evaluate the efficacy of drops of cannabis oil in crohn's disease patients compared to placebo. Treatment success will be defined as a decrease of at least 100 points in CDAI after 8 weeks of treatment.
Secondary aims:
- Remission of disease i.e CDAI of less the 150 points.
- Improvement of at least one point in Endoscopic disease activity index
- Improvement of CRP and calprotectine
- Improvement of blood cytokine levels
- Improvement of at least 30 points in quality of life as measured by the SF 36. In addition the investigators will monitor side effects by questionnaires addressed to the patients and to a significant relative of the patients.
- Conditions
- Crohn's Disease
- Being tested
- THC 5mg/ml and CBS 50mg/ml, Placebo
- Keywords
- Crohn's disease, IBD Cannabis, THC, CBD
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THC 5mg/ml and CBS 50mg/mlDrug
olive oil containing THC and CBD
PlaceboDrug
olive oil without cannabis
| Study group | Role | What they receive |
|---|---|---|
| THC 5 mg/ml and CBD 50 mg/ml. | Active comparator | olive oil containing THC 5 mg/ml and CBD 50 mg/ml. which will be taken twice daily. Receives: Drug: THC 5mg/ml and CBS 50mg/ml |
| Placebo | Placebo comparator | olive oil but without any active ingredients. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment sucsess will be defind as a decrease of at least 100 points in CDAI after 8 weeks of treatment.
The aim of the proposed study in to evaluate the efficacy of drops of cannabis oil in crohn's diseas patients compared to placebo. Treatment sucsess will be defind as a decrease of at least 100 points in CDAI after 8 weeks of treatment.
Measured: 8 weeks
Secondary outcomes (5)
Remission of disease
- Remission of disease i.e CDAI of less the 150 points.
Measured: 8 weeks
endoscopic improvment
- Improvment of at least one point in Endoscopic disease activity index
Measured: 8 week
Improvment of CRP and calprotectine
CRP and calprotectine will be measured before and after 8 weeks of study treatment
Measured: 8 week
Improvment of blood cytokine levls
blood cytokine levls including IL-10, TNF, and IL 23 will be measured before and at the end of the study
Measured: 8 weeks
Improvment of at least 30 points in quality of life as measured by the SF 36.
patients will answer a short form of Health related quality of life quasionnair before and at the end of the study.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826188
- Sponsor's protocol ID
- 0196-12-MMC
- Status last verified
- Mar 2019
- First submitted
- 28 Mar 2013
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Naftali T, Lev LB, Yablecovitch D, Half E, Konikoff FM. Treatment of Crohn's disease with cannabis: an observational study. Isr Med Assoc J. 2011 Aug;13(8):455-8.
PubMed 21910367
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined THC and CBD Drops for Treatment of Crohn's Disease, a Phase II Double Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT01826188
- Acronym / sponsor ID
- 0196-12-MMC
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, IBD Cannabis, THC, CBD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 8 Apr 2013 (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.
There are many reports about efficacy of Cannabis in Crohn's disease but no controlled trials. The aim of the proposed trial is to investigate the efficacy of oil containing the cannabinoids THC and CBD given by mouth for induction of remission in Crohn's disease.
Detailed description
The investigators have recently published a retrospective observational study about the beneficial effect of cannabis in Crohn's disease. The investigators have also concluded a double blind placebo controlled study of Inhaled cannabis in the treatment of Crohn's disease. Both studies have shown significant symptomatic improvement of disease. However, objective parameters of inflammation were not measured. The question arises as to whether the observed improvement is merely symptomatic or due to a real change in inflammation. In addition, administration per os is a healthier option than smoking but the efficacy of oral cannabis was not investigated.
The aim of the proposed study in to evaluate the efficacy of drops of cannabis oil in crohn's disease patients compared to placebo. Treatment success will be defined as a decrease of at least 100 points in CDAI after 8 weeks of treatment.
Secondary aims:
- Remission of disease i.e CDAI of less the 150 points.
- Improvement of at least one point in Endoscopic disease activity index
- Improvement of CRP and calprotectine
- Improvement of blood cytokine levels
- Improvement of at least 30 points in quality of life as measured by the SF 36. In addition the investigators will monitor side effects by questionnaires addressed to the patients and to a significant relative of the patients.
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 |
|---|---|---|
| THC 5 mg/ml and CBD 50 mg/ml. | Active comparator | Drug: THC 5mg/ml and CBS 50mg/mlolive oil containing THC 5 mg/ml and CBD 50 mg/ml. which will be taken twice daily. |
| Placebo | Placebo comparator | Drug: Placeboolive oil but without any active ingredients. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with a diagnosis of Crohn's disease of at least 3 months duration, which was proved by either endoscopy or appropriate imaging study.
- Patients who have failed treatment with either 5 ASA or corticosteroids or immunomodulators or biologic agents, or steroid dependant patients, or patients who were treated by the above mentioned drugs and could not tolerate them due to side effects.
- Age 20 or older.
- Able to sign informed concent
- Active Crohn's disease with a CDAI 200 or more.
Key exclusion criteria (7 listed)
- Patients with a diagnosis of a mental disorder
- Patients who by the judgment of their physician are likely to develop drug addiction.
- Pregnant women or women who are intending to become pregnant
- Patients with a known cannabis allergy
- Patients who are not capable of giving an 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 |
|---|---|---|
| THC 5mg/ml and CBS 50mg/mlolive oil containing THC and CBD | Drug | THC 5 mg/ml and CBD 50 mg/ml. |
| Placeboolive oil without cannabis | Drug | Placebo |
Primary outcome
Treatment sucsess will be defind as a decrease of at least 100 points in CDAI after 8 weeks of treatment.
Time frame: 8 weeks
The aim of the proposed study in to evaluate the efficacy of drops of cannabis oil in crohn's diseas patients compared to placebo. Treatment sucsess will be defind as a decrease of at least 100 points in CDAI after 8 weeks of treatment.
5 secondary outcomes
Remission of disease
Time frame: 8 weeks
endoscopic improvment
Time frame: 8 week
Improvment of CRP and calprotectine
Time frame: 8 week
Improvment of blood cytokine levls
Time frame: 8 weeks
Improvment of at least 30 points in quality of life as measured by the SF 36.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Background: PubMed 21910367Naftali T, Lev LB, Yablecovitch D, Half E, Konikoff FM. Treatment of Crohn's disease with cannabis: an observational study. Isr Med Assoc J. 2011 Aug;13(8):455-8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 THC 5mg/ml and CBS 50mg/ml in people with Crohn's Disease, run by Meir Medical Center at 1 site 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment sucsess will be defind as a decrease of at least 100 points in CDAI after 8 weeks of treatment. (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 NCT01826188, which also lists 1 linked publication.
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 8 Mar 2019.