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

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University of Pittsburgh

Status

Terminated

Conditions

Smoking, Cigarette
Schizophrenia
Transcranial Direct Current Stimulation

Treatments

Other: Transcranial Direct Current Stimulation
Behavioral: Cognitive Remediation (CR)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03588728
R21DA045137 (U.S. NIH Grant/Contract)
tDCS

Details and patient eligibility

About

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.

Full 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.

Enrollment

39 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

39 participants in 4 patient groups

CR + tDCS
Experimental group
Description:
Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Treatment:
Behavioral: Cognitive Remediation (CR)
Other: Transcranial Direct Current Stimulation
CR + sham tDCS
Sham Comparator group
Description:
Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
Treatment:
Behavioral: Cognitive Remediation (CR)
control CR + tDCS
Sham Comparator group
Description:
Control Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Treatment:
Other: Transcranial Direct Current Stimulation
control CR + sham tDCS
No Intervention group
Description:
Control Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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