Effectiveness of Cannabis in the Treatment of Tinnitus Patients
This study is currently recruiting participants.
(see Contacts and Locations)
Verified January 2015 by Wolfson Medical Center
Sponsor:
Wolfson Medical Center
Information provided by (Responsible Party):
Oron Yahav, Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01969474
First received: October 14, 2013
Last updated: January 16, 2015
Last verified: January 2015
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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 2015 (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
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 | 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: | January 16, 2015 |
| 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 February 25, 2015