Marijuana SmokingPhase 2/3NCT01025700
Nabilone & Marijuana Addiction
A Phase 2/3 study testing Cesemat in people with Marijuana Smoking, run by University of British Columbia at 1 site in Canada.
Trial summary
Safety of Nabilone in reducing marijuana craving Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Marijuana Smoking
- What is being tested?
- Cesemat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2009to Oct 2010
- Phase
- Phase 2/3
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 years or older
- History of marijuana use
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vancouver General Hospital - Psychiatry Outpatient
Vancouver, British Columbia
About this study
Official title: A Double-Blind Placebo Control Study on the Use of Nabilone for Outpatient Management of Acute Marijuana Withdrawal
Safety of Nabilone in reducing marijuana craving
Read the detailed description
Randomized double blind trial into the safety and efficacy of Cesemat for the treatment of marijuana use
- Conditions
- Marijuana Smoking
- Being tested
- Cesemat
- Keywords
- Efficacy, Marijuana, Reduction, Craving
- Medical subject headings
- Marijuana Smoking, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CesematDrug
Also called Nabilone
1 mg capsule per day for 21 days
| Study group | Role | What they receive |
|---|---|---|
| Cesemat | Experimental | Not described Receives: Drug: Cesemat |
| Placebo | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability to Nabilone
Secondary outcomes (1)
Marijuana craving questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marijuana SmokingStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- Shaohua Lu, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025700
- Sponsor's protocol ID
- H08-01999
- Status last verified
- Feb 2011
- First submitted
- 2 Dec 2009
- Last updated
- 17 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Placebo Control Study on the Use of Nabilone for Outpatient Management of Acute Marijuana Withdrawal
- ClinicalTrials.gov ID
- NCT01025700
- Acronym / sponsor ID
- H08-01999
- Conditions
- Marijuana Smoking
- Keywords
- Efficacy, Marijuana, Reduction, Craving
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 3 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.
Safety of Nabilone in reducing marijuana craving
Detailed description
Randomized double blind trial into the safety and efficacy of Cesemat for the treatment of marijuana use
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cesemat | Experimental | Drug: Cesemat |
| Placebo | No intervention | – |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 19 years or older
- History of marijuana use
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CesematAlso: Nabilone1 mg capsule per day for 21 days | Drug | Cesemat |
Primary outcome
Safety and tolerability to Nabilone
1 secondary outcome
Marijuana craving questionnaire
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 17 Feb 2011.
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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.
Shaohua Lu, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cesemat in people with Marijuana Smoking, run by University of British Columbia at 1 site in Canada.
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 2 inclusion and 0 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 17 Feb 2011. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Safety and tolerability to Nabilone. 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 17 Feb 2011.