Multiple SclerosisPhase 1/2NCT00260741
Cannabis for Spasticity in Multiple Sclerosis
A Phase 1/2 study testing Smoked Cannabis in people with Multiple Sclerosis, run by Center for Medicinal Cannabis Research at 1 site in United States.
Trial summary
The purpose of this study is to learn if the use of inhaled cannabis (marijuana) and oral cannabinoid (dronabinol, Marinol or THC, which is an active ingredient of marijuana) is safe and effective in reducing the symptoms of spasticity and tremor in patients with secondary-progressive or primary progressive multiple… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Smoked Cannabis
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Jan 2006
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of clinically definite multiple sclerosis as defined by Poser criteria
- Primary or secondary disease course
- Moderate or severe spasticity
- Age 21 or older
Who cannot join
- Preexisting pulmonary conditions, including poorly controlled asthma, chronic bronchitis, emphysema, bronchiectasis, and other significant pulmonary disorders
- Preexisting cardiac conditions, including ischemic heart disease, congestive heart failure, and other significant cardiac disorders
- Inability to abstain from tobacco or marijuana smoking, or use of alcohol or sedative or hypnotic medications during the duration of the study
- Past history of abuse of recreational drugs, including marijuana and alcohol in the last 12 months
- History of or currently meets DSM-IV criteria for dependence on cannabis
- Use of cannabis, marijuana, or THC in the last two weeks
Show all 12Show fewer
- Preexisting dementia, mania, depression, or schizophrenia or other poorly controlled psychiatric illness
- Exacerbation of MS within 30 days prior to screenin visit
- Current use of cyclophosphamide, mitoxanthrone, or cladribine
- Arthritis, bony and soft tissue disorders interfering with spasticity measures
- Inability to provide informed consent
- Recent cannabis use of more than twice per week one month prior to study entry
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
Official title: Cannabis for Spasticity in Multiple Sclerosis: A Placebo-Controlled Study
The purpose of this study is to learn if the use of inhaled cannabis (marijuana) and oral cannabinoid (dronabinol, Marinol or THC, which is an active ingredient of marijuana) is safe and effective in reducing the symptoms of spasticity and tremor in patients with secondary-progressive or primary progressive multiple sclerosis.
Read the detailed description
The treatment of MS is far from satisfactory. For acute attacks, high dose corticosteroids seem to reduce the duration of attacks and to reduce the likelihood of future attacks. Immunomodulatory agents, available in this disease over the last decade, reduce the frequency of severe attacks by about one third. The remainder of the treatments are symptomatic, aimed at reducing the disability already present.
Recent research into the CB1 and CB2 cannabinoid receptor systems suggest that cannabis may have the potential for affecting both the pathogenic mechanisms and the symptoms of MS. In light of the autoimmune hypothesis of the etiology of MS, THC could directly alter immune function in a manner that might reduce (or increase) the primary pathology of the disease.
Comparisons: Three treatment arms will be compared: 1) inhaled cannabis and oral placebo, 2) inhaled placebo and oral THC, 3) inhaled placebo and oral placebo, with the effects of these agents analyzed at thirty and sixty days.
- Conditions
- Multiple Sclerosis
- Being tested
- Smoked Cannabis
- Keywords
- cannabis, marijuana, Multiple Sclerosis, Spasticity
- Medical subject headings
- Multiple Sclerosis, Marijuana Abuse, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoked CannabisDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in an objective measurement of spasticity between the pretreatment assessment and the 4- and 8-week assessments.
Secondary outcomes (1)
Differences between active agent and placebo in the changes in Ashworth Scale, Functional System Score, Expanded Disability Status Score, Ambulation Index, Functional Composite Score, and Quality of Life Inventory.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2005 (estimated)
- Study startMar 2003
- Study completionJan 2006
Why it stopped: Discontinued due to non-enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Center for Medicinal Cannabis Research
- Sponsor type
- University, hospital or other
- Investigators
- Mark Agius, M.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260741
- Sponsor's protocol ID
- C00-DA-112
- Other IDs
- 200311404-4
- Status last verified
- Apr 2007
- First submitted
- 30 Nov 2005
- Last updated
- 4 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabis for Spasticity in Multiple Sclerosis: A Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT00260741
- Acronym / sponsor ID
- C00-DA-112
- Conditions
- Multiple Sclerosis
- Keywords
- cannabis, marijuana, Multiple Sclerosis, Spasticity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Discontinued due to non-enrollment.
- Enrolment
- 60 participants
- Lead sponsor
- Center for Medicinal Cannabis ResearchUniversity, hospital or other
- Study start
- Mar 2003
- Study completion
- Jan 2006 (actual)
- First posted
- 2 Dec 2005 (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.
The purpose of this study is to learn if the use of inhaled cannabis (marijuana) and oral cannabinoid (dronabinol, Marinol or THC, which is an active ingredient of marijuana) is safe and effective in reducing the symptoms of spasticity and tremor in patients with secondary-progressive or primary progressive multiple sclerosis.
Detailed description
The treatment of MS is far from satisfactory. For acute attacks, high dose corticosteroids seem to reduce the duration of attacks and to reduce the likelihood of future attacks. Immunomodulatory agents, available in this disease over the last decade, reduce the frequency of severe attacks by about one third. The remainder of the treatments are symptomatic, aimed at reducing the disability already present.
Recent research into the CB1 and CB2 cannabinoid receptor systems suggest that cannabis may have the potential for affecting both the pathogenic mechanisms and the symptoms of MS. In light of the autoimmune hypothesis of the etiology of MS, THC could directly alter immune function in a manner that might reduce (or increase) the primary pathology of the disease.
Comparisons: Three treatment arms will be compared: 1) inhaled cannabis and oral placebo, 2) inhaled placebo and oral THC, 3) inhaled placebo and oral placebo, with the effects of these agents analyzed at thirty and sixty days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of clinically definite multiple sclerosis as defined by Poser criteria
- Primary or secondary disease course
- Moderate or severe spasticity
- Age 21 or older
Key exclusion criteria (12 listed)
- Preexisting pulmonary conditions, including poorly controlled asthma, chronic bronchitis, emphysema, bronchiectasis, and other significant pulmonary disorders
- Preexisting cardiac conditions, including ischemic heart disease, congestive heart failure, and other significant cardiac disorders
- Inability to abstain from tobacco or marijuana smoking, or use of alcohol or sedative or hypnotic medications during the duration of the study
- Past history of abuse of recreational drugs, including marijuana and alcohol in the last 12 months
- History of or currently meets DSM-IV criteria for dependence on cannabis
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 |
|---|---|---|
| Smoked Cannabis | Drug | – |
Primary outcome
Change in an objective measurement of spasticity between the pretreatment assessment and the 4- and 8-week assessments.
1 secondary outcome
Differences between active agent and placebo in the changes in Ashworth Scale, Functional System Score, Expanded Disability Status Score, Ambulation Index, Functional Composite Score, and Quality of Life Inventory.
Results and safety
The study was stopped early (reason given: Discontinued due to non-enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2007.
- Center for Medicinal Cannabis ResearchLink provided by the sponsor.
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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.
Mark Agius, M.D. principal investigator
University of California, Davis
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 Smoked Cannabis in people with Multiple Sclerosis, run by Center for Medicinal Cannabis Research at 1 site in United States.
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 12 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: stopped early, as of the sponsor's last update on 4 Apr 2007. 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 United States. 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. 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 was stopped early (reason given: Discontinued due to non-enrollment.). Results are not available in the source record.
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?
Change in an objective measurement of spasticity between the pretreatment assessment and the 4- and 8-week assessments.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2007.