Marijuana AbusePhase 1/2NCT00543036
Efficacy and Safety of the Hcoil Deep TMS for the Treatment of Cannabis Addiction
A Phase 1/2 study testing H-Coil deep TMS in people with Marijuana Abuse, run by Shalvata Mental Health Center at 1 site in Israel.
Trial summary
Evaluation of efficacy and safety of H-coil deep transcranial magnetic stimulation 9 week treatment trial for cannabis addiction as assessed by measures of drug intake and craving. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Marijuana Abuse
- What is being tested?
- H-Coil deep TMS
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and Female, aged 21-70 years, who meet DSM-IV TR diagnostic criteria for cannabis abuse and are motivated to quit cannabis use as assessed in the screening visit and gave their written informed consent to participate in the study.
Who cannot join
- History of a primary major psychiatric other then cannabis abuse, or cognitive disorder according to DSM-IV TR criteria.
- Hamilton depression scale rated 25 and above (moderate to severe depression)
- Current alcohol or other substance abuse or dependence
- Alcohol or other substance abuse or dependence during the last 12 months before recruitment.
- History of or evidence of significant brain malformation,neoplasm, head injury, cerebral vascular events,neurodegenerative disorder or brain surgery.
- Severe somatic co-morbidity
- History of seizures Cardiac pace maker or other electronic implants Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Shalvata Mental Health Center
Hod HaSharon, 45100
Ziv Carmel, M.D, +972-9-7478570, zivca@clalit.org.il
Ziv Carmel, M.D
About this study
Evaluation of efficacy and safety of H-coil deep transcranial magnetic stimulation 9 week treatment trial for cannabis addiction as assessed by measures of drug intake and craving.
- Conditions
- Marijuana Abuse
- Being tested
- H-Coil deep TMS
- Keywords
- Cannabis, Addiction, Craving, TMS
- Medical subject headings
- Marijuana Abuse, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H-Coil deep TMSDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marijuana AbuseStudies 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
- Who is masked
- Participant, Investigator
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Investigators
- Ziv Carmel, M.D, Principal investigator, Shalvata MHC affiliated to Tel-Aviv universtiy, Sackler school of medicineAbraham Zangen, Ph.D., Principal investigator, Weizmann Institute, Rehovot, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543036
- Sponsor's protocol ID
- SH 30107
- Status last verified
- Aug 2007
- First submitted
- 11 Oct 2007
- Last updated
- 12 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Hcoil Deep TMS for the Treatment of Cannabis Addiction
- ClinicalTrials.gov ID
- NCT00543036
- Acronym / sponsor ID
- SH 30107
- Conditions
- Marijuana Abuse
- Keywords
- Cannabis, Addiction, Craving, TMS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- First posted
- 12 Oct 2007 (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.
Evaluation of efficacy and safety of H-coil deep transcranial magnetic stimulation 9 week treatment trial for cannabis addiction as assessed by measures of drug intake and craving.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and Female, aged 21-70 years, who meet DSM-IV TR diagnostic criteria for cannabis abuse and are motivated to quit cannabis use as assessed in the screening visit and gave their written informed consent to participate in the study.
Key exclusion criteria (7 listed)
- History of a primary major psychiatric other then cannabis abuse, or cognitive disorder according to DSM-IV TR criteria.
- Hamilton depression scale rated 25 and above (moderate to severe depression)
- Current alcohol or other substance abuse or dependence
- Alcohol or other substance abuse or dependence during the last 12 months before recruitment.
- History of or evidence of significant brain malformation,neoplasm, head injury, cerebral vascular events,neurodegenerative disorder or brain surgery.
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 |
|---|---|---|
| H-Coil deep TMS | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2007.
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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.
Ziv Carmel, M.D principal investigator
Shalvata MHC affiliated to Tel-Aviv universtiy, Sackler school of medicine
Abraham Zangen, Ph.D. principal investigator
Weizmann Institute, Rehovot, Israel
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 H-Coil deep TMS in people with Marijuana Abuse, run by Shalvata Mental Health 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 1 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: status not confirmed, as of the sponsor's last update on 12 Oct 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 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. 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 Ziv Carmel, M.D. (+972-9-7478570, zivca@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 12 Oct 2007.