TNS for Treating Nicotine Craving

NCT ID: NCT02178852

Last Updated: 2014-07-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31

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.

Conditions

Nicotine Craving

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

TNS-active

TRIGEMINAL NERVE STIMULATION (TNS)

Group Type: EXPERIMENTAL

TRIGEMINAL NERVE STIMULATION (TNS)

Intervention Type: DEVICE

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

TNS-sham

TRIGEMINAL NERVE STIMULATION (TNS) - sham

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

TRIGEMINAL NERVE STIMULATION (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

Intervention Type: DEVICE

Other Intervention Names

TNS

Eligibility Criteria

Inclusion Criteria

1. patients over 18 years

2. both genres

3. diagnosed with nicotine related disorder for at least 12 months according to the diagnostic criteria of DSM-IV administered by a psychiatrist.

5. Finally, patients should be able to read and understand the portuguese language.

6. Patients will be selected from spontaneous demand. In accordance to informed consent -

Exclusion Criteria

1. other psychiatric diagnosis such as bipolar Affective Disorder, alcohol dependence, schizophrenia and dementia.

2. 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.

3. 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.

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Santa Casa Medical School

OTHER

Sponsor Role: lead

Responsible Party

Pedro Shiozawa

Coordinator Neuromodulation Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruno Shiozawa, MD

Role: PRINCIPAL_INVESTIGATOR

Neuromodulation Laboratory - Santa Casa Medical School

Pedro Shiozawa, MD

Role: STUDY_DIRECTOR

Neuromodulation Laboratory - Santa Casa Medical School

Quirino Cordeiro, MD PhD

Role: STUDY_CHAIR

Neuromodulation Laboratory - Santa Casa Medical School

Locations

Centro de Atencao Integrada à Saúde Mental - CAISM

São Paulo, São Paulo, Brazil

Countries

Brazil

Central Contacts

Pedro Shiozawa, MD

Role: CONTACT

pedroshiozawa@gmail.com

551134662105

Quirino Cordeiro, MD PhD

Role: CONTACT

qcordeiro@yahoo.com

551134662100

Facility Contacts

Pedro Shiozawa, MD

Role: primary

pedroshiozawa@gmail.com

551134662105

References

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.

Reference Type: BACKGROUND

PMID: 24814566 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24242143 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24154668 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24065930 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23133419 (View on PubMed)

Other Identifiers

TNS-nicotine

Identifier Type: -

Identifier Source: org_study_id