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

Marijuana Abuse Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00543036
• Other study ID #: SH 30107
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: October 11, 2007
• Last updated: October 11, 2007

Study information

• Verified date: August 2007
• Source: Shalvata Mental Health Center
• Contact: Ziv Carmel, M.D.
• Phone: +972-9-7478570
• Email: zivca[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Marijuana Abuse

Intervention

Device:
• H-Coil deep TMS

Locations

Country	Name	City	State
Israel	Shalvata Mental Health Center	Hod-HaSharon

Sponsors (1)

Lead Sponsor	Collaborator
Shalvata Mental Health Center

Country where clinical trial is conducted

Israel,