Effectiveness of Cannabis in the Treatment of Tinnitus Patients

December 25, 2016 updated by: Oron Yahav, Wolfson Medical Center

Phase 1 Study to Study the Efficacy and Safety of Cannabis in the Treatment of Tinnitus

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Holon, Israel
        • Wolfson Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo
Experimental: Cannabis
Treatment with a Cannabis capsule
Cannabis capsules given once daily for a month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tinnitus handicap inventory score
Time Frame: 2 months
Patients will be monitored during a month (treatment time) and a month later
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 14, 2013

First Submitted That Met QC Criteria

October 21, 2013

First Posted (Estimate)

October 25, 2013

Study Record Updates

Last Update Posted (Estimate)

December 28, 2016

Last Update Submitted That Met QC Criteria

December 25, 2016

Last Verified

December 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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