Effectiveness of Cannabis in the Treatment of Tinnitus Patients

Tinnitus Clinical Trial

Official title:

Phase 1 Study to Study the Efficacy and Safety of Cannabis in the Treatment of Tinnitus

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01969474
• Other study ID #: 1.01
• Status: Withdrawn
• Phase: Phase 1
• First received: October 14, 2013
• Last updated: December 25, 2016
• Start date: December 2013

Study information

• Verified date: December 2016
• Source: Wolfson Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The hypothesis of the study is that the use of Cannabis will attenuate the tinnitus level as experienced by the patients.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Tinnitus lasting more than 3 months

• Tinnitus Handicap Inventory score over 58

• Treated previously for tinnitus (2 modalities)

Exclusion Criteria:

• Prior use of drugs

• Current use of Cannabis

• Neurologic or Psychiatric disease

• Heart Failure

• Ischemic Heart Disease

• Immune Deficiency

• Acoustic Neuroma

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Marijuana Abuse
• Tinnitus

Intervention

Drug:
• Cannabis
Cannabis capsules given once daily for a month
• Placebo
Placebo

Locations

Country	Name	City	State
Israel	Wolfson Medical Centre	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tinnitus handicap inventory score	Patients will be monitored during a month (treatment time) and a month later	2 months	No