TinnitusPhase 1NCT01969474
Effectiveness of Cannabis in the Treatment of Tinnitus Patients
A Phase 1 study testing Cannabis in people with Tinnitus, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
The hypothesis of the study is that the use of Cannabis will attenuate the tinnitus level as experienced by the patients. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- Cannabis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2013to Dec 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tinnitus lasting more than 3 months
- Tinnitus Handicap Inventory score over 58
- Treated previously for tinnitus (2 modalities)
Who cannot join
- Prior use of drugs
- Current use of Cannabis
- Neurologic or Psychiatric disease
- Heart Failure
- Ischemic Heart Disease
- Immune Deficiency
- Acoustic Neuroma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Tinnitus
- Being tested
- Cannabis, Placebo
- Keywords
- Tinnitus Cannabis
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabisDrug
Cannabis capsules given once daily for a month
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cannabis | Experimental | Treatment with a Cannabis capsule Receives: Drug: Cannabis |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus handicap inventory score
Patients will be monitored during a month (treatment time) and a month later
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Oron Yahav, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969474
- Sponsor's protocol ID
- 1.01
- Status last verified
- Dec 2016
- First submitted
- 14 Oct 2013
- Last updated
- 28 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Study the Efficacy and Safety of Cannabis in the Treatment of Tinnitus
- ClinicalTrials.gov ID
- NCT01969474
- Acronym / sponsor ID
- 1.01
- Conditions
- Tinnitus
- Keywords
- Tinnitus Cannabis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Dec 2013
- Primary completion
- Dec 2016 (estimated)
- First posted
- 25 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of the study is that the use of Cannabis will attenuate the tinnitus level as experienced by the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabis | Experimental | Drug: CannabisTreatment with a Cannabis capsule |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Tinnitus lasting more than 3 months
- Tinnitus Handicap Inventory score over 58
- Treated previously for tinnitus (2 modalities)
Key exclusion criteria (7 listed)
- Prior use of drugs
- Current use of Cannabis
- Neurologic or Psychiatric disease
- Heart Failure
- Ischemic Heart Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabisCannabis capsules given once daily for a month | Drug | Cannabis |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Tinnitus handicap inventory score
Time frame: 2 months
Patients will be monitored during a month (treatment time) and a month later
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2016.
Related trials for Tinnitus
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
RecruitingPhase 2
A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B)
Tinnitus
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cannabis in people with Tinnitus, run by Wolfson Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus handicap inventory score (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2016.