NCT01969474

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 25, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

December 28, 2016

Status Verified

December 1, 2016

Enrollment Period

3 years

First QC Date

October 14, 2013

Last Update Submit

December 25, 2016

Conditions

Tinnitus

Keywords

Tinnitus Cannabis

Outcome Measures

Primary Outcomes (1)

  • Tinnitus handicap inventory score

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

    2 months

Study Arms (2)

Cannabis

EXPERIMENTAL

Treatment with a Cannabis capsule

Drug: Cannabis

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

CannabisDRUG

Cannabis capsules given once daily for a month

Cannabis
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Tinnitus lasting more than 3 months
  • Tinnitus Handicap Inventory score over 58
  • Treated previously for tinnitus (2 modalities)

You may not qualify if:

  • Prior use of drugs
  • Current use of Cannabis
  • Neurologic or Psychiatric disease
  • Heart Failure
  • Ischemic Heart Disease
  • Immune Deficiency
  • Acoustic Neuroma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wolfson Medical Centre

Holon, Israel

Location

MeSH Terms

Conditions

Tinnitus

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 14, 2013

First Posted

October 25, 2013

Study Start

December 1, 2013

Primary Completion

December 1, 2016

Last Updated

December 28, 2016

Record last verified: 2016-12

Locations

IL(1)