Tobacco Use DisorderNCT02776319
Effects of Non-invasive Brain Stimulation in Tobacco Use Disorder
A study testing Non-invasive brain stimulation (active) in people with Tobacco Use Disorder, run by Laval University at 1 site in Canada.
Trial summary
The objective of the study is to determine the effect of non-invasive brain stimulation on craving for tobacco and brain metabolites. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Non-invasive brain stimulation (active)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- May 2016to Dec 2016
- Phase
- Interventional
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Tobacco use disorder (DSM-V)
Who cannot join
- Other psychiatric disorders
- Contraindication to non-invasive brain stimulation and MRI
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Social
Québec, Quebec, G1M2S8
About this study
The objective of the study is to determine the effect of non-invasive brain stimulation on craving for tobacco and brain metabolites.
- Conditions
- Tobacco Use Disorder
- Being tested
- Non-invasive brain stimulation (active), Non-invasive brain stimulation (sham)
- Keywords
- Non-invasive brain stimulation, tobacco use disorder, craving
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive brain stimulation (active)Device
Non-invasive brain stimulation (active)
Non-invasive brain stimulation (sham)Device
Non-invasive brain stimulation (sham)
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Non-invasive brain stimulation (active) Receives: Device: Non-invasive brain stimulation (active) |
| Sham/Placebo | Placebo comparator | Non-invasive brain stimulation (sham) Receives: Device: Non-invasive brain stimulation (sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tobacco craving
Subjective craving scale
Measured: During experimentation
Secondary outcomes (1)
Brain metabolites
Magnetic resonance imaging
Measured: During experimentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirley Fecteau, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776319
- Sponsor's protocol ID
- 2015-465
- Status last verified
- May 2016
- First submitted
- 16 May 2016
- Last updated
- 18 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Non-invasive Brain Stimulation in Tobacco Use Disorder
- ClinicalTrials.gov ID
- NCT02776319
- Acronym / sponsor ID
- 2015-465
- Conditions
- Tobacco Use Disorder
- Keywords
- Non-invasive brain stimulation, tobacco use disorder, craving
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 18 May 2016 (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 objective of the study is to determine the effect of non-invasive brain stimulation on craving for tobacco and brain metabolites.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Device: Non-invasive brain stimulation (active)Non-invasive brain stimulation (active) |
| Sham/Placebo | Placebo comparator | Device: Non-invasive brain stimulation (sham)Non-invasive brain stimulation (sham) |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Tobacco use disorder (DSM-V)
Key exclusion criteria (2 listed)
- Other psychiatric disorders
- Contraindication to non-invasive brain stimulation and MRI
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 |
|---|---|---|
| Non-invasive brain stimulation (active)Non-invasive brain stimulation (active) | Device | Active |
| Non-invasive brain stimulation (sham)Non-invasive brain stimulation (sham) | Device | Sham/Placebo |
Primary outcome
Tobacco craving
Time frame: During experimentation
Subjective craving scale
1 secondary outcome
Brain metabolites
Time frame: During experimentation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive brain stimulation (active) in people with Tobacco Use Disorder, run by Laval University at 1 site in Canada.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 May 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 Canada. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antoine Hone-Blanchet, MSC (4185299141 ext. 2460, antoine.hone-blanchet.1@ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tobacco craving (time frame: During experimentation). 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 18 May 2016.