Transcranial Direct Current Stimulation (tDCS) As A Treatment For Cigarette Craving and Cognitive Deficits in Schizophrenic

NCT02128919 | Completed Results

• 1 other identifier: 309320
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study of the effects of tDCS on smoking, craving for cigarettes, cognition, and psychiatric symptoms in schizophrenic patients who are current smokers or have a history of regular cigarette smoking. It assesses smoking with CO monitoring, nicotine and nicotine levels, and craving with QSU scale and response to craving slides. Cognition is measured by MCCB, symptoms are measured by PANSS and hallucination scale. This is a double-blind sham-controlled study with active tDCS 2ma or 20 minutes over 5 days, and sham tDCS for 40 seconds on each sham occasion.

Conditions

Schizophrenia; Cognition; Cigarette Smoking

Keywords

Schizophrenia; Cigarette smoking; Cognition; Craving; MATRICS

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Cigarette Craving

  The Brief Questionnaire on Smoking Urges (QSU-Brief) was used to measure cigarette cravings. Scores ranged from a minimum of 1 ("Strongly Disagree") to a maximum of 7 ("Strongly Agree") and were determined by self-reported responses to 10 statements about having cravings for smoking. Scores closer to 1 after treatment would indicate a better outcome. Responses to each of the 10 items in the scale were summed for one total score. With 10 items on this scale with a range of scores from 1 to 7, on each occasion of rating the minimum score would be 7 and the maximum score would be 70.

  Baseline and after 5 tDCs sessions (mean time 8.7[SD 2.7] days after basleine)

Secondary Outcomes (1)

• Change From Baseline in Cognitive Performance

  Baseline and 1-3 days (mean 1.8 [SD 1.4] days after 5 tDCS sessions( mean 8.7 days after baseline)

Other Outcomes (1)

• Change From Baseline in Psychiatric Symptoms

  Baseline and after 5 tDCS sessions

Study Arms (2)

Active tDCS

EXPERIMENTAL

tDCS 2 ma for 20 minutes with anode at DLPFC once a day for 5 days

Device: tDCS

Sham tDCS

SHAM COMPARATOR

tDCS 2 ma for 40 seconds with anode at DLPFC for 5 days

Device: tDCS

Interventions

tDCS DEVICE

Transcranial Direct Current Stimulation

Active tDCS; Sham tDCS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of schizophrenia spectrum disorder History of cigarette smoking

You may not qualify if:

• Seizure disorder or current treated neurological illness Current Acute exacerbation of psychotic state

Sponsors & Collaborators

• Nathan Kline Institute for Psychiatric Research: lead

Study Sites (1)

Nathan Kline Institute for Psychiatric Research

Orangeburg, New York, 10962, United States

Location

Related Publications (1)

• Smith RC, Boules S, Mattiuz S, Youssef M, Tobe RH, Sershen H, Lajtha A, Nolan K, Amiaz R, Davis JM. Effects of transcranial direct current stimulation (tDCS) on cognition, symptoms, and smoking in schizophrenia: A randomized controlled study. Schizophr Res. 2015 Oct;168(1-2):260-6. doi: 10.1016/j.schres.2015.06.011. Epub 2015 Jul 17.

  PMID: 26190299 RESULT

MeSH Terms

Conditions

Schizophrenia; Cigarette Smoking

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Robert C Smith MD
• Organization: Nathan Kline institute for Psycghatric Research

rsmiith@nki.rfmh.org

845-398-6531

Study Officials

• Robert C Smith, MD

  Nathsan Kline Institute for Psychiatric Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychiatrist

Study Record Dates

• First Submitted: April 26, 2014
• First Posted: May 1, 2014
• Study Start: April 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 30, 2017
• Results First Posted: August 25, 2017

Record last verified: 2017-08

Locations

US (1)