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

Primary Purpose

Marijuana Abuse

Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
H-Coil deep TMS
Sponsored by
Shalvata Mental Health Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Marijuana Abuse focused on measuring Cannabis, Addiction, Craving, TMS

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shalvata Mental Health CenterRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 11, 2007
Last Updated
October 11, 2007
Sponsor
Shalvata Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT00543036
Brief Title
Efficacy and Safety of the Hcoil Deep TMS for the Treatment of Cannabis Addiction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Shalvata Mental Health Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Abuse
Keywords
Cannabis, Addiction, Craving, TMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
H-Coil deep TMS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ziv Carmel, M.D.
Phone
+972-9-7478570
Email
zivca@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziv Carmel, M.D
Organizational Affiliation
Shalvata MHC affiliated to Tel-Aviv universtiy, Sackler school of medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abraham Zangen, Ph.D.
Organizational Affiliation
Weizmann Institute, Rehovot, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shalvata Mental Health Center
City
Hod-HaSharon
ZIP/Postal Code
45100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziv Carmel, M.D
Phone
+972-9-7478570
Email
zivca@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Ziv Carmel, M.D

12. IPD Sharing Statement

Learn more about this trial

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

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