tDCS and Cognitive Training Intervention for Chronic Smokers With Schizophrenia (TACTICSS)

February 15, 2023 updated by: Cynthia Conklin, University of Pittsburgh
This study is being done to develop new methods to help smokers with schizophrenia to successfully reduce their smoking and/or quit. This is not a treatment study, but will help find new techniques to create better treatments. Specifically, the investigators are interested in learning more about how thoughts and attention problems associated with schizophrenia might play a role in smoking, as well as the impact of cognitive (thinking, reasoning, and remembering) training and brain stimulation on these symptoms and on actual smoking.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Adults with severe mental illness (SMI) are three times more likely to smoke than non-SMI adults, consuming 35-44% of all cigarettes in the U.S.; and, the highest rates of tobacco-related illnesses and death are among smokers with schizophrenia. Unfortunately, not only are patients with schizophrenia less likely to receive smoking treatments, but cessation medications are only modestly effective in helping this subset of smokers quit. Therefore, it is vital to discover new treatment adjuncts that specifically aid this high-risk subset of smokers to achieve successful abstinence. Toward that end, the investigators propose a novel non-pharmacologic technique that directly targets both cognitive impairment, an avenue considerable past research suggests may be particularly effective to exploit in smokers with schizophrenia, and reactivity to prepotent stimuli, shown to be enhanced in smokers with schizophrenia. Combining a subset of cognitive enhancement therapy known as Cognitive Remediation (CR), with another safe and effective technique, Transcranial Direct Current Stimulation (tDCS), the investigators propose a new cognitive training method aimed at enabling smokers with schizophrenia to gain greater control over smoking and stimuli-induced reactivity (e.g., craving). Recent studies have found significant tDCS-induced cognitive enhancement, as well as reduction in both cue-induced craving and smoking behavior among healthy smokers. This combined with knowledge of the cognitive deficits that exist among individuals with schizophrenia, and clear evidence of a relationship between cognitive function and smoking treatment success, provides the rationale for testing novel CR + tDCS to target underlying mechanisms of smoking among individuals with schizophrenia. Specifically, the proposed study will examine the extent to which targeted cognitive enhancement with CR + tDCS, leads to changes in cognitive control, cue-provoked craving, reaction time and ERP measures of attentional bias; as well as the impact of these changes on smoking behavior and intention and confidence to quit among 80 smokers with schizophrenia. The goal of this study is to inform the development of new non-medication, noninvasive, therapeutic techniques to specifically target smoking among patients with schizophrenia. The long term goal is to establish an effective treatment adjunct to help smokers with schizophrenia successfully achieve abstinence.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Currently meets DSM-5 criteria for Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, or Delusional Disorder.
  • Ability to provide written informed consent
  • Smoke ≥ 7 cigarettes per day
  • Expired breath CO ≥ 10 ppm at screening
  • Stable medication regimen for ≥ 4 weeks (If on more than one psychotropic medication, main antipsychotic will be considered for stability)

Exclusion Criteria:

  • Epilepsy or Current Seizure Disorder
  • Alcohol or Substance Dependence past 3 months (caffeine allowed, nicotine is part of inclusion criteria).
  • Pregnant or lactating
  • Psychiatric hospitalization in past 3 months
  • Suicidal and/or aggressive behavior past 3 months
  • Implanted cardiac or brain medical devices
  • Latex allergy
  • Scalp irritation or recent shaving of scalp
  • Use of other smoking cessation medication
  • History of head trauma
  • History of ECT

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CR + tDCS
Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Other: Transcranial Direct Current Stimulation
Transcranial direct current stimulation targeting the right inferior frontal gyrus
Other Names:
  • tDCS
Behavioral: Cognitive Remediation (CR)
Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
Sham Comparator: CR + sham tDCS
Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
Behavioral: Cognitive Remediation (CR)
Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
Sham Comparator: control CR + tDCS
Control Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Other: Transcranial Direct Current Stimulation
Transcranial direct current stimulation targeting the right inferior frontal gyrus
Other Names:
  • tDCS
No Intervention: control CR + sham tDCS
Control Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS™): MATRICS Consensus Cognitive Battery (MCCB)
Time Frame: Baseline to approximately 4 weeks
the MATRICS Consensus battery (MCCB) is a cognitive battery of tests for assessing cognition-enhancing treatments for schizophrenia through a broadly based scientific evaluation of measures. Change in cognitive measures of MATRICS Consensus Cognitive Battery (MCCB). Post-intervention minus baseline. Scale is scored 0-100. Difference score range is (-100 to 100) with positive scores reflecting improvement.
Baseline to approximately 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cue-Reactivity
Time Frame: Baseline to approximately 4 weeks
Change in cue-induced craving indexed as change in self-report craving on the questionnaire of smoking urges, 4-item version (QSU-4) from baseline to end of intervention. Craving rating range = 0-100. Difference scores range from (-100 to 100) with a negative score reflecting improvement.
Baseline to approximately 4 weeks
Cigarette Puff Volume
Time Frame: Baseline and at approximately 4 weeks
Change in mean cigarette puff volume
Baseline and at approximately 4 weeks
Latency to First Cigarette Puff
Time Frame: Baseline to approximately 4 weeks
Change in mean latency to first cigarette puff
Baseline to approximately 4 weeks
AX Version of the Continuous Performance Task (AX-CPT) Reaction Time
Time Frame: Baseline to approximately 4 weeks
AX version of the CPT measures a participant's active maintenance and cognitive control. In this task, the participant is presented with a series of trials in which they are instructed to make a response which distinguishes between stimuli. Here the stimuli included are: smoking, nonsmoking, person, non-person). Assessment is of Post - Pre intervention difference in reaction time to respond to stimuli on the AX Version of the Continuous Performance Task (AX-CPT)
Baseline to approximately 4 weeks
AX Version of the Continuous Performance Task (AX-CPT) Reaction Time Variability
Time Frame: Baseline to approximately 4 weeks
Post minus pre-intervention difference Reaction time variability for hits on the AX Version of the Continuous Performance Task (AX-CPT). A negative value indicates improvement.
Baseline to approximately 4 weeks
EEG (Electroencephalogram) N170 Amplitude
Time Frame: Baseline to approximately 4 weeks
Difference in change scores (post minus pre-intervention) in N170 Amplitude between smoking and neutral images. A more negative score indicates greater improvement.
Baseline to approximately 4 weeks
EEG (Electroencephalogram) Contingent Negative Variation (CNV)
Time Frame: Baseline to approximately 4 weeks
Difference in CNV between the A and X in the AX-CPT Task. More negative indicates larger CNV.
Baseline to approximately 4 weeks
EEG (Electroencephalogram) Beta-Band Event-Related Desynchronization (ERD)
Time Frame: Baseline to approximately 4 weeks
Difference in ERD between the A and X in AX-CPT during EEG assessment of Beta-Band Event-Related Desynchronization (ERD). More negative values indicate greater Beta-band ERD at post-intervention.
Baseline to approximately 4 weeks
Attention & Smoking Cue Exposure Task (ASCET)
Time Frame: Baseline to approximately 4 weeks
Post minus Pre-intervention difference in Reaction time between smoking and neutral images presented with the ASCET task. A negative RT indicates improvement.
Baseline to approximately 4 weeks
Total Number of Puffs
Time Frame: Baseline to approximately 4 weeks
Change in number of puffs on cigarettes assessment during smoking topography measurement during the cue reactivity task. Number of puffs was assessed during pre-training cue reactivity and again during post-training cue reactivity.
Baseline to approximately 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2018

Primary Completion (Actual)

March 12, 2020

Study Completion (Actual)

March 12, 2020

Study Registration Dates

First Submitted

July 3, 2018

First Submitted That Met QC Criteria

July 3, 2018

First Posted (Actual)

July 17, 2018

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tDCS
  • R21DA045137 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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