Effectiveness of Cannabis in the Treatment of Tinnitus Patients

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by (Responsible Party):

Oron Yahav, Wolfson Medical Center

ClinicalTrials.gov Identifier:

NCT01969474

First received: October 14, 2013

Last updated: December 25, 2016

Last verified: December 2016

History of Changes

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:

MedlinePlus related topics: Marijuana Tinnitus

U.S. FDA Resources

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


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

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

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
Study First Received:	October 14, 2013
Last Updated:	December 25, 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

ClinicalTrials.gov processed this record on August 18, 2017

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