TNS for Treating Nicotine Craving

Nicotine Craving Clinical Trial

— TNS-nicotine  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02178852
• Other study ID #: TNS-nicotine
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: June 26, 2014
• Last updated: June 27, 2014
• Start date: August 2014

Study information

• Verified date: June 2014
• Source: Santa Casa Medical School
• Contact: Pedro Shiozawa, MD
• Phone: 551134662105
• Email: pedroshiozawa[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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.

4. Also we will adopt as inclusion criteria a score of Nicotine Dependence Fagerstrom Test greater or equal to 5 points.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nicotine Craving

Intervention

Device:
• 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

Locations

Country	Name	City	State
Brazil	Centro de Atencao Integrada à Saúde Mental - CAISM	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Santa Casa Medical School

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

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. — View 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. — View 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. Review. Dutch. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	(T1) Immediately before TNS protocol ; (T2) 30 minutes after TNS protocol	Yes