search
Back to results

Effectiveness of Cannabis in the Treatment of Tinnitus Patients

Primary Purpose

Tinnitus

Status
Withdrawn
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Cannabis
Placebo
Sponsored by
Wolfson Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Tinnitus Cannabis

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wolfson Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cannabis

Placebo

Arm Description

Treatment with a Cannabis capsule

Placebo

Outcomes

Primary Outcome Measures

Tinnitus handicap inventory score
Patients will be monitored during a month (treatment time) and a month later

Secondary Outcome Measures

Full Information

First Posted
October 14, 2013
Last Updated
December 25, 2016
Sponsor
Wolfson Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01969474
Brief Title
Effectiveness of Cannabis in the Treatment of Tinnitus Patients
Official Title
Phase 1 Study to Study the Efficacy and Safety of Cannabis in the Treatment of Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Withdrawn
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wolfson Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
Tinnitus Cannabis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cannabis
Arm Type
Experimental
Arm Description
Treatment with a Cannabis capsule
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Cannabis
Intervention Description
Cannabis capsules given once daily for a month
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Tinnitus handicap inventory score
Description
Patients will be monitored during a month (treatment time) and a month later
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Wolfson Medical Centre
City
Holon
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Cannabis in the Treatment of Tinnitus Patients

We'll reach out to this number within 24 hrs