Efficacy and Safety of the Hcoil Deep TMS for the Treatme... | NCT00543036

Studies
Efficacy and Safety of the Hcoil Deep TMS for the Treatment of Cannabis Addiction

NCT00543036

Sponsor

Shalvata Mental Health Center

Status

Unknown status

Last Update Posted

Oct 12, 2007Estimated

Enrollment

Not provided

Phase

Phase 1Phase 2

Conditions

Marijuana Abuse

Interventions

H-Coil deep TMS

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 11, 2007

First Submission Date that Met QC Criteria

Oct 11, 2007

First Posted Date

Oct 12, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2007

Last Update Posted Date

Oct 12, 2007Estimated

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
H-Coil deep TMS	Device

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ziv Carmel, M.D.	Contact	+972-9-7478570		zivca@clalit.org.il

Overall Officials

Name	Affiliation	Role
Ziv Carmel, M.D	Shalvata MHC affiliated to Tel-Aviv universtiy, Sackler school of medicine	Principal Investigator
Abraham Zangen, Ph.D.	Weizmann Institute, Rehovot, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shalvata Mental Health Center	Recruiting	Hod HaSharon		45100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D002189	Marijuana Abuse
D016739	Behavior, Addictive

Ancestor Terms

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D003192	Compulsive Behavior

Browse Leaves

Not provided

Browse Branches

Not provided