Effectiveness of Cannabis in the Treatment of Tinnitus Patients

• Sponsor: Wolfson Medical Center (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01969474
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tinnitus	Drug: Cannabis; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• 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: Dec 1, 2013
• Anticipated Primary Completion Date: Dec 1, 2016

Arms and Interventions

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

Primary Outcome Measures

1. Tinnitus handicap inventory score [2 months]

   Patients will be monitored during a month (treatment time) and a month later

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Wolfson Medical Centre	Holon		Israel

Sponsors and Collaborators

• Wolfson Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Oron Yahav, MD, Wolfson Medical Center
• ClinicalTrials.gov Identifier: NCT01969474
• Other Study ID Numbers: 1.01
• First Posted: Oct 25, 2013
• Last Update Posted: Dec 28, 2016
• Last Verified: Dec 1, 2016

• Keywords provided by Oron Yahav, MD, Wolfson Medical Center: Tinnitus Cannabis
• Additional relevant MeSH terms: Tinnitus; Marijuana Abuse

Study Results

No Results Posted as of Dec 28, 2016