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TNS for Treating Nicotine Craving (TNS-nicotine)

Primary Purpose

Nicotine Craving

Status

Unknown status

Phase

Phase 1

Locations

Brazil

Study Type

Interventional

Intervention

TRIGEMINAL NERVE STIMULATION (TNS)

About this trial

This is an interventional treatment trial for Nicotine Craving

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 -

Exclusion Criteria:

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.
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Sites / Locations

Centro de Atencao Integrada à Saúde Mental - CAISM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TNS-active

TNS-sham

Arm Description

TRIGEMINAL NERVE STIMULATION (TNS)

TRIGEMINAL NERVE STIMULATION (TNS) - sham

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02178852

First Posted

June 26, 2014

Last Updated

June 27, 2014

Sponsor

Santa Casa Medical School

1. Study Identification

Unique Protocol Identification Number

NCT02178852

Brief Title

TNS for Treating Nicotine Craving

Acronym

TNS-nicotine

Official Title

Effect of Trigeminal Nerve Stimulation (TNS) on Nicotine Craving: Phase II, Cross-over, Randomized, Sham-controlled Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Unknown status

Study Start Date

August 2014 (undefined)

Primary Completion Date

August 2015 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Santa Casa Medical School

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nicotine Craving

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TNS-active

Arm Type

Experimental

Arm Description

TRIGEMINAL NERVE STIMULATION (TNS)

Arm Title

TNS-sham

Arm Type

Placebo Comparator

Arm Description

TRIGEMINAL NERVE STIMULATION (TNS) - sham

Intervention Type

Device

Intervention Name(s)

TRIGEMINAL NERVE STIMULATION (TNS)

Other Intervention Name(s)

TNS

Intervention Description

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

Primary Outcome Measure Information:

Title

Craving for nicotine

Description

Time Frame

(T1) Immediately before TNS protocol ; (T2) 30 minutes after TNS protocol

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 - Exclusion Criteria: 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. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pedro Shiozawa, MD

Phone

551134662105

pedroshiozawa@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Quirino Cordeiro, MD PhD

Phone

551134662100

qcordeiro@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruno Shiozawa, MD

Organizational Affiliation

Neuromodulation Laboratory - Santa Casa Medical School

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Pedro Shiozawa, MD

Organizational Affiliation

Neuromodulation Laboratory - Santa Casa Medical School

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Quirino Cordeiro, MD PhD

Organizational Affiliation

Neuromodulation Laboratory - Santa Casa Medical School

Official's Role

Study Chair

Facility Information:

Facility Name

Centro de Atencao Integrada à Saúde Mental - CAISM

City

Sao Paulo

State/Province

ZIP/Postal Code

04017030

Country

Brazil

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pedro Shiozawa, MD

Phone

551134662105

pedroshiozawa@gmail.com

First Name & Middle Initial & Last Name & Degree

Pedro Shiozawa, MD

First Name & Middle Initial & Last Name & Degree

Bruno Shiozawa, MD

First Name & Middle Initial & Last Name & Degree

Quirino Cordeiro, MD PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

24814566

Citation

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.

Results Reference

background

PubMed Identifier

24242143

Citation

Luigjes 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.

Results Reference

background

PubMed Identifier

24154668

Citation

Pedron 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.

Results Reference

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PubMed Identifier

24065930

Citation

Xu 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.

Results Reference

background

PubMed Identifier

23133419

Citation

Grundey 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.

Results Reference

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TNS for Treating Nicotine Craving

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