Nicotine CravingPhase 1/2TNS-nicotineNCT02178852
TNS for Treating Nicotine Craving
A Phase 1/2 study testing TRIGEMINAL NERVE STIMULATION (TNS) in people with Nicotine Craving, run by Santa Casa Medical School at 1 site in Brazil.
Trial summary
Electrical stimulation provides direct modulatory effects on subcortical regions. Indeed, neuroimaging studies show changes in neural activity in specific brain regions such as the amygdala, insula, precentral gyrus, hippocampus and thalamus. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Nicotine Craving
- What is being tested?
- TRIGEMINAL NERVE STIMULATION (TNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2014to Aug 2015
- Phase
- Phase 1/2
- 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 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over 18 years
- both genres
- diagnosed with nicotine related disorder for at least 12 months according to the diagnostic criteria of DSM-IV administered by a psychiatrist.
- Also we will adopt as inclusion criteria a score of Nicotine Dependence Fagerstrom Test greater or equal to 5 points.
- Finally, patients should be able to read and understand the portuguese language.
- Patients will be selected from spontaneous demand. In accordance to informed consent -
Who cannot join
- other psychiatric diagnosis such as bipolar Affective Disorder, alcohol dependence, schizophrenia and dementia.
- Also excluded patients with severe neurological or medical diseases, such as neurodegenerative diseases, stroke, cancer in activity, congestive heart failure or chronic obstructive pulmonary disease stage III or IV.
- Finally, patients with severe suicidal ideation (structured planning suicide or attempted suicide in the past 4 weeks) will be excluded. In this case, the patient will be seen immediately by a psychiatrist of the research itself that will take the appropriate clinical management according to the severity of suicidal thinking.
- -
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de Atencao Integrada à Saúde Mental - CAISM
São Paulo, São Paulo, 04017030
Pedro Shiozawa, MD, 551134662105, pedroshiozawa@gmail.com
Pedro Shiozawa, MD
About this study
Official title: Effect of Trigeminal Nerve Stimulation (TNS) on Nicotine Craving: Phase II, Cross-over, Randomized, Sham-controlled Clinical Trial
Electrical stimulation provides direct modulatory effects on subcortical regions. Indeed, neuroimaging studies show changes in neural activity in specific brain regions such as the amygdala, insula, precentral gyrus, hippocampus and thalamus. The neuroanatomical connections established with the trigeminal nerve have been associated with the mechanism called "bottom-up" neuromodulation. According to this hypothesis, the spread of electrical stimulation follows a path from the peripheral nerves towards the brain stem was then advertise for cortical and subcortical regions. Connections to structures involved in the reward system as the amygdala and hippocampus could theoretically modulate dysfunctional brain activity in these regions, which may induce favorable clinical effects.
- Conditions
- Nicotine Craving
- Being tested
- TRIGEMINAL NERVE STIMULATION (TNS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRIGEMINAL NERVE STIMULATION (TNS)Device
Also called TNS
TNS stimulation over V1 branches of V cranial nerve. Single session for 30 minutes. The patient will undergo a specific cue-induced cigarette craving model during the final 3 minutes of stimulation. Craving scores will be rated before and after stimulation
| Study group | Role | What they receive |
|---|---|---|
| TNS-active | Experimental | TRIGEMINAL NERVE STIMULATION (TNS) Receives: Device: TRIGEMINAL NERVE STIMULATION (TNS) |
| TNS-sham | Placebo comparator | TRIGEMINAL NERVE STIMULATION (TNS) - sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Craving for nicotine
Craving for nicotine assessed by visual scale before and after cue-induced images for nicotine craving. Patients will be exposed to visual model for cue-induced images related to nicotine craving during the last 3 minutes of the TNS protocol (which has an overall time of 30 minutes). Main comparison will be between T1 and T2 craving level.
Measured: (T1) Immediately before TNS protocol ; (T2) 30 minutes after TNS protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nicotine CravingStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santa Casa Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Shiozawa, Santa Casa Medical School
- Investigators
- Bruno Shiozawa, MD, Principal investigator, Neuromodulation Laboratory - Santa Casa Medical SchoolPedro Shiozawa, MD, Study director, Neuromodulation Laboratory - Santa Casa Medical SchoolQuirino Cordeiro, MD PhD, Study chair, Neuromodulation Laboratory - Santa Casa Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178852
- Sponsor's protocol ID
- TNS-nicotine
- Acronym
- TNS-nicotine
- Status last verified
- Jun 2014
- First submitted
- 26 Jun 2014
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Fecteau S, Agosta S, Hone-Blanchet A, Fregni F, Boggio P, Ciraulo D, Pascual-Leone A. Modulation of smoking and decision-making behaviors with transcranial direct current stimulation in tobacco smokers: a preliminary study. Drug Alcohol Depend. 2014 Jul 1;140:78-84. doi: 10.1016/j.drugalcdep.2014.03.036. Epub 2014 Apr 16.
PubMed 24814566Luigjes J, Breteler R, Vanneste S, de Ridder D. [Neuromodulation as an intervention for addiction: overview and future prospects]. Tijdschr Psychiatr. 2013;55(11):841-52. Dutch.
PubMed 24242143Pedron S, Monnin J, Haffen E, Sechter D, Van Waes V. Repeated transcranial direct current stimulation prevents abnormal behaviors associated with abstinence from chronic nicotine consumption. Neuropsychopharmacology. 2014 Mar;39(4):981-8. doi: 10.1038/npp.2013.298. Epub 2013 Oct 24.
PubMed 24154668Xu J, Fregni F, Brody AL, Rahman AS. Transcranial direct current stimulation reduces negative affect but not cigarette craving in overnight abstinent smokers. Front Psychiatry. 2013 Sep 20;4:112. doi: 10.3389/fpsyt.2013.00112. eCollection 2013.
PubMed 24065930Grundey J, Thirugnanasambandam N, Kaminsky K, Drees A, Skwirba AC, Lang N, Paulus W, Nitsche MA. Rapid effect of nicotine intake on neuroplasticity in non-smoking humans. Front Pharmacol. 2012 Oct 26;3:186. doi: 10.3389/fphar.2012.00186. eCollection 2012.
PubMed 23133419
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Trigeminal Nerve Stimulation (TNS) on Nicotine Craving: Phase II, Cross-over, Randomized, Sham-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02178852
- Acronym / sponsor ID
- TNS-nicotine / TNS-nicotine
- Conditions
- Nicotine Craving
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Santa Casa Medical SchoolUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2015 (estimated)
- First posted
- 1 Jul 2014 (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.
Electrical stimulation provides direct modulatory effects on subcortical regions. Indeed, neuroimaging studies show changes in neural activity in specific brain regions such as the amygdala, insula, precentral gyrus, hippocampus and thalamus. The neuroanatomical connections established with the trigeminal nerve have been associated with the mechanism called "bottom-up" neuromodulation. According to this hypothesis, the spread of electrical stimulation follows a path from the peripheral nerves towards the brain stem was then advertise for cortical and subcortical regions. Connections to structures involved in the reward system as the amygdala and hippocampus could theoretically modulate dysfunctional brain activity in these regions, which may induce favorable clinical effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNS-active | Experimental | Device: TRIGEMINAL NERVE STIMULATION (TNS)TRIGEMINAL NERVE STIMULATION (TNS) |
| TNS-sham | Placebo comparator | –TRIGEMINAL NERVE STIMULATION (TNS) - sham |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients over 18 years
- both genres
- diagnosed with nicotine related disorder for at least 12 months according to the diagnostic criteria of DSM-IV administered by a psychiatrist.
- Also we will adopt as inclusion criteria a score of Nicotine Dependence Fagerstrom Test greater or equal to 5 points.
- Finally, patients should be able to read and understand the portuguese language.
Key exclusion criteria (4 listed)
- other psychiatric diagnosis such as bipolar Affective Disorder, alcohol dependence, schizophrenia and dementia.
- Also excluded patients with severe neurological or medical diseases, such as neurodegenerative diseases, stroke, cancer in activity, congestive heart failure or chronic obstructive pulmonary disease stage III or IV.
- Finally, patients with severe suicidal ideation (structured planning suicide or attempted suicide in the past 4 weeks) will be excluded. In this case, the patient will be seen immediately by a psychiatrist of the research itself that will take the appropriate clinical management according to the severity of suicidal thinking.
- -
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 |
|---|---|---|
| TRIGEMINAL NERVE STIMULATION (TNS)Also: TNSTNS stimulation over V1 branches of V cranial nerve. Single session for 30 minutes. The patient will undergo a specific cue-induced cigarette craving model during the final 3 minutes of stimulation. Craving scores will be rated before and after stimulation | Device | TNS-active |
Primary outcome
Craving for nicotine
Time frame: (T1) Immediately before TNS protocol ; (T2) 30 minutes after TNS protocol
Craving for nicotine assessed by visual scale before and after cue-induced images for nicotine craving. Patients will be exposed to visual model for cue-induced images related to nicotine craving during the last 3 minutes of the TNS protocol (which has an overall time of 30 minutes). Main comparison will be between T1 and T2 craving level.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2014.
- Background: PubMed 24814566Fecteau S, Agosta S, Hone-Blanchet A, Fregni F, Boggio P, Ciraulo D, Pascual-Leone A. Modulation of smoking and decision-making behaviors with transcranial direct current stimulation in tobacco smokers: a preliminary study. Drug Alcohol Depend. 2014 Jul 1;140:78-84. doi: 10.1016/j.drugalcdep.2014.03.036. Epub 2014 Apr 16.
- Background: PubMed 24242143Luigjes J, Breteler R, Vanneste S, de Ridder D. [Neuromodulation as an intervention for addiction: overview and future prospects]. Tijdschr Psychiatr. 2013;55(11):841-52. Dutch.
- Background: PubMed 24154668Pedron S, Monnin J, Haffen E, Sechter D, Van Waes V. Repeated transcranial direct current stimulation prevents abnormal behaviors associated with abstinence from chronic nicotine consumption. Neuropsychopharmacology. 2014 Mar;39(4):981-8. doi: 10.1038/npp.2013.298. Epub 2013 Oct 24.
- Background: PubMed 24065930Xu J, Fregni F, Brody AL, Rahman AS. Transcranial direct current stimulation reduces negative affect but not cigarette craving in overnight abstinent smokers. Front Psychiatry. 2013 Sep 20;4:112. doi: 10.3389/fpsyt.2013.00112. eCollection 2013.
- Background: PubMed 23133419Grundey J, Thirugnanasambandam N, Kaminsky K, Drees A, Skwirba AC, Lang N, Paulus W, Nitsche MA. Rapid effect of nicotine intake on neuroplasticity in non-smoking humans. Front Pharmacol. 2012 Oct 26;3:186. doi: 10.3389/fphar.2012.00186. eCollection 2012.
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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.
Bruno Shiozawa, MD principal investigator
Neuromodulation Laboratory - Santa Casa Medical School
Pedro Shiozawa, MD study director
Neuromodulation Laboratory - Santa Casa Medical School
Quirino Cordeiro, MD PhD study chair
Neuromodulation Laboratory - Santa Casa Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TRIGEMINAL NERVE STIMULATION (TNS) in people with Nicotine Craving, run by Santa Casa Medical School at 1 site in Brazil.
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 4 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 1 Jul 2014. 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 Brazil. 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pedro Shiozawa, MD (551134662105, pedroshiozawa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Craving for nicotine (time frame: (T1) Immediately before TNS protocol ; (T2) 30 minutes after TNS protocol). 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 NCT02178852, which also lists 5 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 1 Jul 2014.