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Effectiveness of Cannabis in the Treatment of Tinnitus Patients

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01969474
First Posted: October 25, 2013
Last Update Posted: December 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Oron Yahav, Wolfson Medical Center
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Oron Yahav, Wolfson Medical Center:

Primary Outcome Measures:
  • Tinnitus handicap inventory score [ Time Frame: 2 months ]
    Patients will be monitored during a month (treatment time) and a month later


Enrollment: 0
Study Start Date: December 2013
Estimated Primary Completion Date: December 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01969474


Locations
Israel
Wolfson Medical Centre
Holon, Israel
Sponsors and Collaborators
Wolfson Medical Center
  More Information

Responsible Party: Oron Yahav, MD, Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01969474     History of Changes
Other Study ID Numbers: 1.01
First Submitted: October 14, 2013
First Posted: October 25, 2013
Last Update Posted: December 28, 2016
Last Verified: December 2016

Keywords provided by Oron Yahav, Wolfson Medical Center:
Tinnitus Cannabis

Additional relevant MeSH terms:
Tinnitus
Marijuana Abuse
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders