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

NCT ID: NCT02128919

Last Updated: 2017-08-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia Cognition Cigarette Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active tDCS

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

Group Type EXPERIMENTAL

tDCS

Intervention Type DEVICE

Transcranial Direct Current Stimulation

Sham tDCS

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

Group Type SHAM_COMPARATOR

tDCS

Intervention Type DEVICE

Transcranial Direct Current Stimulation

Interventions

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tDCS

Transcranial Direct Current Stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of schizophrenia spectrum disorder History of cigarette smoking

Exclusion Criteria

* Seizure disorder or current treated neurological illness Current Acute exacerbation of psychotic state
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nathan Kline Institute for Psychiatric Research

OTHER

Sponsor Role lead

Responsible Party

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Robert C. Smith MD PhD

Research Psychiatrist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert C Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Nathsan Kline Institute for Psychiatric Research

Locations

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Nathan Kline Institute for Psychiatric Research

Orangeburg, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 26190299 (View on PubMed)

Other Identifiers

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309320

Identifier Type: -

Identifier Source: org_study_id

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