Marijuana DependenceNCT00270803
The Effects of Marijuana on Orientation and Motor Coordination and Brain Metabolism in Regular Smokers of Marijuana
A study testing Tetra Hydro Cannabinol (THC) in people with Marijuana Dependence, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
This study investigates the effects of 17mg and 13mg Delta THC on orientation and motor coordination and brain metabolic activity in regular users of marijuana. Subjects were tested twice, after smoking cigarettes with marijuana and after smoking cigarettes without marijuana.On both occasions they performed on a… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Marijuana Dependence
- What is being tested?
- Tetra Hydro Cannabinol (THC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2004to Dec 2005
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Marijuana dependence
- Age 20-65
- Male and female
Who cannot join
- Pregnant women
- Dependence on other substances
- Psychiatric diagnosis apart from marijuana dependence
- Neurological disorder
- Young persons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Marijuana on Orientation and Motor Coordination and Brain Metabolism in Regular Smokers of Marijuana.
This study investigates the effects of 17mg and 13mg Delta THC on orientation and motor coordination and brain metabolic activity in regular users of marijuana. Subjects were tested twice, after smoking cigarettes with marijuana and after smoking cigarettes without marijuana.On both occasions they performed on a virtual reality maze task. They were afterwards scanned in Positron Emission Tomography (PET) with Fluoro-deoxy-glucose (FDG).
Read the detailed description
This study investigates the effects of 17mg and 13mg Delta THC on orientation and motor coordination and brain metabolic activity in regular users of marijuana. Subjects were tested twice, after smoking cigarettes with marijuana and after smoking cigarettes without marijuana. On both occasions they performed on a virtual reality maze task. They were afterwards scanned in Positron Emission Tomography (PET) with Fluoro-deoxy-glucose (FDG). 12 subjects were tested so far on both conditions.
- Conditions
- Marijuana Dependence
- Being tested
- Tetra Hydro Cannabinol (THC)
- Keywords
- Marijuana, FDG, PET, maze, THC, motor coordination.
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetra Hydro Cannabinol (THC)Drug
Also called Marijuana, cannabis
Oral THC 13mg and 17mg smoked in low nicotine cigarettes
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Low nicotine cigarettes without THC Receives: Drug: Tetra Hydro Cannabinol (THC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain metabolic activity (FDG)
Measured: 30-40 minutes
Secondary outcomes (2)
Reaction time (RTs) and errors in performance
Measured: 40 minutes
Subjective ratings on visual analog scale
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2005 (estimated)
- Study startJul 2004
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marijuana DependenceStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Hadassah Medical Organization
- Investigators
- Aviv M Weinstein, Ph.D, Principal investigator, Sourasky Medical CenterEinat Even-Sapir, M.D. Ph.D, Principal investigator, Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00270803
- Sponsor's protocol ID
- TASMC-05-EE-03-124-CTIL
- Status last verified
- Dec 2005
- First submitted
- 25 Dec 2005
- Last updated
- 7 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Marijuana on Orientation and Motor Coordination and Brain Metabolism in Regular Smokers of Marijuana.
- ClinicalTrials.gov ID
- NCT00270803
- Acronym / sponsor ID
- TASMC-05-EE-03-124-CTIL
- Conditions
- Marijuana Dependence
- Keywords
- Marijuana, FDG, PET, maze, THC, motor coordination.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Hadassah Medical Organization
- Study start
- Jul 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 28 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.
This study investigates the effects of 17mg and 13mg Delta THC on orientation and motor coordination and brain metabolic activity in regular users of marijuana. Subjects were tested twice, after smoking cigarettes with marijuana and after smoking cigarettes without marijuana.On both occasions they performed on a virtual reality maze task. They were afterwards scanned in Positron Emission Tomography (PET) with Fluoro-deoxy-glucose (FDG).
Detailed description
This study investigates the effects of 17mg and 13mg Delta THC on orientation and motor coordination and brain metabolic activity in regular users of marijuana. Subjects were tested twice, after smoking cigarettes with marijuana and after smoking cigarettes without marijuana. On both occasions they performed on a virtual reality maze task. They were afterwards scanned in Positron Emission Tomography (PET) with Fluoro-deoxy-glucose (FDG). 12 subjects were tested so far on both conditions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: Tetra Hydro Cannabinol (THC)Low nicotine cigarettes without THC |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Marijuana dependence
- Age 20-65
- Male and female
Key exclusion criteria (5 listed)
- Pregnant women
- Dependence on other substances
- Psychiatric diagnosis apart from marijuana dependence
- Neurological disorder
- Young persons
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 |
|---|---|---|
| Tetra Hydro Cannabinol (THC)Also: Marijuana, cannabisOral THC 13mg and 17mg smoked in low nicotine cigarettes | Drug | A |
Primary outcome
Brain metabolic activity (FDG)
Time frame: 30-40 minutes
2 secondary outcomes
Reaction time (RTs) and errors in performance
Time frame: 40 minutes
Subjective ratings on visual analog scale
Time frame: 10 minutes
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 7 May 2008.
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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.
Aviv M Weinstein, Ph.D principal investigator
Sourasky Medical Center
Einat Even-Sapir, M.D. Ph.D principal investigator
Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tetra Hydro Cannabinol (THC) in people with Marijuana Dependence, run by Tel-Aviv Sourasky 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 3 inclusion and 5 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 7 May 2008. 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.
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?
Brain metabolic activity (FDG) (time frame: 30-40 minutes). 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 7 May 2008.