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Effectiveness of Cannabis in the Treatment of Tinnitus Patients

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Recruitment Status : Withdrawn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

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
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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
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cannabis
Treatment with a Cannabis capsule
 Drug: Cannabis
Cannabis capsules given once daily for a month
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Placebo


Outcome Measures
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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


Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Oron Yahav, MD, Wolfson Medical Center
ClinicalTrials.gov 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:
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