Effectiveness of Cannabis in the Treatment of Tinnitus Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Wolfson Medical Center
Sponsor:
Information provided by (Responsible Party):
Oron Yahav, Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01969474
First received: October 14, 2013
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Tinnitus
Drug: Cannabis
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1 Study to Study the Efficacy and Safety of Cannabis in the Treatment of Tinnitus

Resource links provided by NLM:


Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • Tinnitus handicap inventory score [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Patients will be monitored during a month (treatment time) and a month later


Estimated Enrollment: 20
Study Start Date: December 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cannabis
Treatment with a Cannabis capsule
Drug: Cannabis
Cannabis capsules given once daily for a month
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01969474

Contacts
Contact: Yahav Oron, MD +972-35028651 oron.yahav@gmail.com

Locations
Israel
Wolfson Medical Centre Not yet recruiting
Holon, Israel
Contact: Yahav Oron         
Principal Investigator: Yahav Oron, MD         
Sponsors and Collaborators
Wolfson Medical Center
  More Information

No publications provided

Responsible Party: Oron Yahav, MD, Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01969474     History of Changes
Other Study ID Numbers: 1.01
Study First Received: October 14, 2013
Last Updated: October 21, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Wolfson Medical Center:
Tinnitus Cannabis

Additional relevant MeSH terms:
Tinnitus
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014