Nicotine DependencePhase 2tDCSNCT01710410
Transcranial Direct Current Stimulation in a Smoking Cessation Trial
A Phase 2 study testing active transcranial Direct Current Stimulation in people with Nicotine Dependence, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The purpose of this study is to determine the effectiveness of transcranial direct current stimulation (tDCS) plus nicotine patch as a viable smoking cessation program for nicotine dependent smokers. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- active transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to Oct 2016
- Phase
- Phase 2
- 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- nicotine dependent
- treatment-seeking
- smoke minimum of 15 cigarettes per day
- able to provide written informed consent
- able and willing to attend weekly appointments, inter-treatment and follow-up assessment
- able and willing to wear nicotine patch
Who cannot join
- currently taking GABA receptor agonists, NMDA receptor antagonists, dopamine receptor agonists/antagonists, SSRIs, L-dopa, anticholinergics
- pregnancy or lactation
- any serious medical condition requiring treatment or medication including high blood pressure, heart problems, asthma, epilepsy
- brain/neurological injury/disease/disorder
- skin disease
- current DSM-IV Axis I psychiatric disorder
Show all 10Show fewer
- metal or medical device implants
- current treatment for alcohol or drug use
- current use of herbal/holistic preparations
- current use of recreational drugs
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Addiction and Mental Health (Nicotine Dependence Clinic)
Toronto, Ontario, M5T 1P5
About this study
Official title: Pilot Study of Transcranial Direct Current Stimulation (tDCS) as a Smoking Cessation Treatment for Nicotine Dependent Smokers
The purpose of this study is to determine the effectiveness of transcranial direct current stimulation (tDCS) plus nicotine patch as a viable smoking cessation program for nicotine dependent smokers.
Read the detailed description
BACKGROUND: Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation that involves the application of brief weak electric current to the scalp. tDCS may induce neuroplasticity, thereby engaging some of the same systems that figure prominently in the pathological neuroplasticity caused by addictive drugs.
OBJECTIVE: To assess whether tDCS delivered along with nicotine patch reliably increases a) quit rates, b) duration of abstinence, and c) percentage of participants abstinent at follow-up.
METHOD: Active (20min; 2mA) and sham (30sec; 2mA) stimulation will be applied to the dorsolateral prefrontal cortex (DLPFC) in both cerebral hemispheres.
HYPOTHESES:
- Active tDCS (20-min; 2 mA) will increase abstinence in a standard smoking cessation protocol relative to a sham procedure.
- The benefits of active left anodal stimulation (anode-left/cathode-right) to the DLPFC will be greater than of active tDCS in the reverse configuration (cathode-left/anode-right).
- Conditions
- Nicotine Dependence
- Being tested
- active transcranial Direct Current Stimulation, sham transcranial Direct Current Stimulation
- Keywords
- transcranial direct current stimulation, nicotine dependence, dorsolateral prefrontal cortex, nicotine replacement therapy, nicotine patch, addiction, smoking cessation, neuroplasticity
- Medical subject headings
- Tobacco Use Disorder, Behavior, Addictive, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active transcranial Direct Current StimulationDevice
Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp.
sham transcranial Direct Current StimulationDevice
Brief (30-sec) application of weak electric current (e.g., 2mA) to the scalp.
| Study group | Role | What they receive |
|---|---|---|
| DLPFC tDCS (left anode/right cathode) | Experimental | Active transcranial Direct Current Stimulation (tDCS) administered to the left DLPFC. Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp. Receives: Device: active transcranial Direct Current Stimulation |
| DLPFC tDCS (left cathode/right anode) | Experimental | Active transcranial Direct Current Stimulation (tDCS) administered to the right DLPFC. Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp. Receives: Device: active transcranial Direct Current Stimulation |
| DLPFC tDCS | Sham comparator | Sham transcranial Direct Current Stimulation (tDCS) delivered to the DLPFC. Brief (30-sec) application of weak electric current (e.g., 2mA) to the scalp. Receives: Device: sham transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Cessation
Measure whether active tDCS increases abstinence in a standard smoking cessation protocol relative to a sham tDCS procedure
Measured: Participants will be followed for the duration of the study, an expected average of 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
- Study startOct 2016
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Nuraleve, Inc.
- Responsible party
- Principal investigator, Laurie Zawertailo, Centre for Addiction and Mental Health
- Investigators
- Laurie Zawertailo, Ph.D., Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710410
- Sponsor's protocol ID
- 016-2015
- Acronym
- tDCS
- Status last verified
- Jun 2016
- First submitted
- 21 Sep 2012
- Last updated
- 13 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Boggio PS, Liguori P, Sultani N, Rezende L, Fecteau S, Fregni F. Cumulative priming effects of cortical stimulation on smoking cue-induced craving. Neurosci Lett. 2009 Sep 29;463(1):82-6. doi: 10.1016/j.neulet.2009.07.041. Epub 2009 Jul 18.
PubMed 19619607Feil J, Zangen A. Brain stimulation in the study and treatment of addiction. Neurosci Biobehav Rev. 2010 Mar;34(4):559-74. doi: 10.1016/j.neubiorev.2009.11.006. Epub 2009 Nov 13.
PubMed 19914283Fregni F, Liguori P, Fecteau S, Nitsche MA, Pascual-Leone A, Boggio PS. Cortical stimulation of the prefrontal cortex with transcranial direct current stimulation reduces cue-provoked smoking craving: a randomized, sham-controlled study. J Clin Psychiatry. 2008 Jan;69(1):32-40. doi: 10.4088/jcp.v69n0105.
PubMed 18312035
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Transcranial Direct Current Stimulation (tDCS) as a Smoking Cessation Treatment for Nicotine Dependent Smokers
- ClinicalTrials.gov ID
- NCT01710410
- Acronym / sponsor ID
- tDCS / 016-2015
- Conditions
- Nicotine Dependence
- Keywords
- transcranial direct current stimulation, nicotine dependence, dorsolateral prefrontal cortex, nicotine replacement therapy, nicotine patch, addiction, smoking cessation, neuroplasticity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Nuraleve, Inc.
- Study start
- Oct 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 19 Oct 2012 (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 the effectiveness of transcranial direct current stimulation (tDCS) plus nicotine patch as a viable smoking cessation program for nicotine dependent smokers.
Detailed description
BACKGROUND: Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation that involves the application of brief weak electric current to the scalp. tDCS may induce neuroplasticity, thereby engaging some of the same systems that figure prominently in the pathological neuroplasticity caused by addictive drugs.
OBJECTIVE: To assess whether tDCS delivered along with nicotine patch reliably increases a) quit rates, b) duration of abstinence, and c) percentage of participants abstinent at follow-up.
METHOD: Active (20min; 2mA) and sham (30sec; 2mA) stimulation will be applied to the dorsolateral prefrontal cortex (DLPFC) in both cerebral hemispheres.
HYPOTHESES:
- Active tDCS (20-min; 2 mA) will increase abstinence in a standard smoking cessation protocol relative to a sham procedure.
- The benefits of active left anodal stimulation (anode-left/cathode-right) to the DLPFC will be greater than of active tDCS in the reverse configuration (cathode-left/anode-right).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DLPFC tDCS (left anode/right cathode) | Experimental | Device: active transcranial Direct Current StimulationActive transcranial Direct Current Stimulation (tDCS) administered to the left DLPFC. Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp. |
| DLPFC tDCS (left cathode/right anode) | Experimental | Device: active transcranial Direct Current StimulationActive transcranial Direct Current Stimulation (tDCS) administered to the right DLPFC. Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp. |
| DLPFC tDCS | Sham comparator | Device: sham transcranial Direct Current StimulationSham transcranial Direct Current Stimulation (tDCS) delivered to the DLPFC. Brief (30-sec) application of weak electric current (e.g., 2mA) to the scalp. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- nicotine dependent
- treatment-seeking
- smoke minimum of 15 cigarettes per day
- able to provide written informed consent
- able and willing to attend weekly appointments, inter-treatment and follow-up assessment
Key exclusion criteria (10 listed)
- currently taking GABA receptor agonists, NMDA receptor antagonists, dopamine receptor agonists/antagonists, SSRIs, L-dopa, anticholinergics
- pregnancy or lactation
- any serious medical condition requiring treatment or medication including high blood pressure, heart problems, asthma, epilepsy
- brain/neurological injury/disease/disorder
- skin 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 |
|---|---|---|
| active transcranial Direct Current StimulationBrief (20-min) application of weak electric current (e.g., 2 mA) to the scalp. | Device | DLPFC tDCS (left anode/right cathode), DLPFC tDCS (left cathode/right anode) |
| sham transcranial Direct Current StimulationBrief (30-sec) application of weak electric current (e.g., 2mA) to the scalp. | Device | DLPFC tDCS |
Primary outcome
Smoking Cessation
Time frame: Participants will be followed for the duration of the study, an expected average of 9 months.
Measure whether active tDCS increases abstinence in a standard smoking cessation protocol relative to a sham tDCS procedure
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 13 Jun 2016.
- Background: PubMed 19619607Boggio PS, Liguori P, Sultani N, Rezende L, Fecteau S, Fregni F. Cumulative priming effects of cortical stimulation on smoking cue-induced craving. Neurosci Lett. 2009 Sep 29;463(1):82-6. doi: 10.1016/j.neulet.2009.07.041. Epub 2009 Jul 18.
- Background: PubMed 19914283Feil J, Zangen A. Brain stimulation in the study and treatment of addiction. Neurosci Biobehav Rev. 2010 Mar;34(4):559-74. doi: 10.1016/j.neubiorev.2009.11.006. Epub 2009 Nov 13.
- Background: PubMed 18312035Fregni F, Liguori P, Fecteau S, Nitsche MA, Pascual-Leone A, Boggio PS. Cortical stimulation of the prefrontal cortex with transcranial direct current stimulation reduces cue-provoked smoking craving: a randomized, sham-controlled study. J Clin Psychiatry. 2008 Jan;69(1):32-40. doi: 10.4088/jcp.v69n0105.
- Centre for Addiction and Mental Health (investigator-driven, not initiated, study)Link provided by the sponsor.
- Ontario Brain InstituteLink provided by the sponsor.
- Nuraleve, Inc. (regulatory sponsor with Health Canada)Link provided by the sponsor.
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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.
Laurie Zawertailo, Ph.D. principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing active transcranial Direct Current Stimulation in people with Nicotine Dependence, run by Centre for Addiction and Mental Health 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 6 inclusion and 10 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 13 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Smoking Cessation (time frame: Participants will be followed for the duration of the study, an expected average of 9 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01710410, which also lists 3 linked publications.
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 13 Jun 2016.