Tobacco Use DisorderNCT02810574
Combining Noninvasive Brain Stimulation and Cognitive Training on Tobacco Craving
A study testing Cognitive training and Noninvasive brain stimulation (active) in people with Tobacco Use Disorder, run by Laval University at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether combining noninvasive brain stimulation with cognitive training can reduce craving in adults with tobacco use disorder. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Cognitive training and Noninvasive brain stimulation (active)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to Sep 2017
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 20-60 years old
- Smoking > 15 cigarettes per day
- Tobacco Use Disorder according to Diagnostic and Statistical Manual V criteria
Who cannot join
- Contraindications to noninvasive brain stimulation
- Psychiatric or neurologic condition
Trial locations and contacts
1 site in 1 country.
Marine Mondino, PhD contact
Canada1 site, 1 recruiting
- Recruiting
Centre Interdisciplinaire de Recherche en Réadaptation et Intégration
Québec, Quebec
Marine Mondino, PhD, 418-529-9141 ext. 6915
About this study
The purpose of this study is to determine whether combining noninvasive brain stimulation with cognitive training can reduce craving in adults with tobacco use disorder.
- Conditions
- Tobacco Use Disorder
- Being tested
- Cognitive training, Noninvasive brain stimulation (active), Noninvasive brain stimulation (sham)
- 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.
Cognitive trainingBehavioural
Noninvasive brain stimulation (active)Device
Neuroconn DC-STIMULATOR PLUS
Noninvasive brain stimulation (sham)Device
Neuroconn DC-STIMULATOR PLUS
| Study group | Role | What they receive |
|---|---|---|
| Active noninvasive brain stimulation and cognitive training | Active comparator | In active condition, subject will receive stimulation during all the 30-minute stimulation period combined with cognitive training. Receives: Behavioral: Cognitive training; Device: Noninvasive brain stimulation (active) |
| Sham noninvasive brain stimulation | Sham comparator | In sham condition, subject will receive stimulation only during the first 30 seconds of the 30-minute stimulation period combined with cognitive training. Receives: Behavioral: Cognitive training; Device: Noninvasive brain stimulation (sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in tobacco craving assessed by the Questionnaire of Smoking Urge
Measured: immediately before and immediately after the end of the noninvasive brain stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2017 (estimated)
- Study completionSep 2017 (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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810574
- Sponsor's protocol ID
- 2013-336
- Status last verified
- Jun 2016
- First submitted
- 31 May 2016
- Last updated
- 23 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Noninvasive Brain Stimulation and Cognitive Training on Tobacco Craving
- ClinicalTrials.gov ID
- NCT02810574
- Acronym / sponsor ID
- 2013-336
- Conditions
- Tobacco Use Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 23 Jun 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 purpose of this study is to determine whether combining noninvasive brain stimulation with cognitive training can reduce craving in adults with tobacco use disorder.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active noninvasive brain stimulation and cognitive training | Active comparator | Behavioral: Cognitive training, Device: Noninvasive brain stimulation (active)In active condition, subject will receive stimulation during all the 30-minute stimulation period combined with cognitive training. |
| Sham noninvasive brain stimulation | Sham comparator | Behavioral: Cognitive training, Device: Noninvasive brain stimulation (sham)In sham condition, subject will receive stimulation only during the first 30 seconds of the 30-minute stimulation period combined with cognitive training. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 20-60 years old
- Smoking > 15 cigarettes per day
- Tobacco Use Disorder according to Diagnostic and Statistical Manual V criteria
Key exclusion criteria (2 listed)
- Contraindications to noninvasive brain stimulation
- Psychiatric or neurologic condition
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 |
|---|---|---|
| Cognitive training | Behavioural | Active noninvasive brain stimulation and cognitive training, Sham noninvasive brain stimulation |
| Noninvasive brain stimulation (active)Neuroconn DC-STIMULATOR PLUS | Device | Active noninvasive brain stimulation and cognitive training |
| Noninvasive brain stimulation (sham)Neuroconn DC-STIMULATOR PLUS | Device | Sham noninvasive brain stimulation |
Primary outcome
Changes in tobacco craving assessed by the Questionnaire of Smoking Urge
Time frame: immediately before and immediately after the end of the noninvasive brain stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 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.
Marine Mondino, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training and Noninvasive 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 3 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 23 Jun 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 Marine Mondino, PhD (418-529-9141 ext. 6915), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in tobacco craving assessed by the Questionnaire of Smoking Urge (time frame: immediately before and immediately after the end of the noninvasive brain stimulation). 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 23 Jun 2016.