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Effectiveness of Cannabis in the Treatment of Tinnitus Patients

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. Identifier: NCT01969474
Recruitment Status : Withdrawn
First Posted : October 25, 2013
Last Update Posted : December 28, 2016
Information provided by (Responsible Party):
Oron Yahav, Wolfson Medical Center

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

Condition or disease Intervention/treatment Phase
Tinnitus Drug: Cannabis Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Study Start Date : December 2013
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana Tinnitus

Arm Intervention/treatment
Experimental: Cannabis
Treatment with a Cannabis capsule
Drug: Cannabis
Cannabis capsules given once daily for a month

Placebo Comparator: Placebo
Drug: Placebo

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01969474

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Wolfson Medical Centre
Holon, Israel
Sponsors and Collaborators
Wolfson Medical Center

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Responsible Party: Oron Yahav, MD, Wolfson Medical Center Identifier: NCT01969474     History of Changes
Other Study ID Numbers: 1.01
First Posted: October 25, 2013    Key Record Dates
Last Update Posted: December 28, 2016
Last Verified: December 2016
Keywords provided by Oron Yahav, Wolfson Medical Center:
Tinnitus Cannabis
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms