TACTICSS: tDCS and Cognitive Training Intervention for Chronic Smokers With Schizophrenia
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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:
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:
|
| No Intervention: control CR + sham tDCS Control Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS) |
Outcome Measures
Primary Outcome Measures
- MATRICS Consensus Cognitive Battery [Baseline and at two weeks]
Change in cognitive measures of MATRICS Cognitive Battery Assessment
Secondary Outcome Measures
- Cue-Reactivity [Baseline and at two weeks]
Change in cue-induced craving
- Number of Cigarette Puffs [Baseline and at two weeks]
Change in mean number of cigarette puffs
- Cigarette Puff Volume [baseline and at two weeks]
Change in mean cigarette puff volume
- Latency to First Cigarette Puff [Baseline and at two weeks]
Change in mean latency to first cigarette puff
- AX Version of the Continuous Performance Task (AX-CPT) Reaction Time [Baseline and at two weeks]
Difference in Reaction time between smoking and neutral images
- AX Version of the Continuous Performance Task (AX-CPT) Reaction Time Variability [Baseline and at two weeks]
Difference in Reaction time variability between smoking and neutral images
- EEG (electroencephalogram) N170 Amplitude [Baseline and at two weeks]
Difference in N170 Amplitude between smoking and neutral images
- EEG (electroencephalogram) Contingent Negative Variation (CNV) [Baseline and at two weeks]
Difference CNV between the A and X in the AX-CPT Task
- EEG (electroencephalogram) Beta-Band Event-Related Desynchronization (ERD) [Baseline and at two weeks]
Difference ERD between the A and X in AX-CPT
- EEG (electroencephalogram) P300 Amplitude [Baseline and at two weeks]
Difference in P300 Amplitude in response to Stop Signal Task
- Attention & Smoking Cue Exposure Task (ASCET) [Baseline and at two weeks]
Difference in Reaction time between smoking and neutral images
- Stop Signal Computer Task [Baseline and at two weeks]
Change in Time to response inhibition
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Currently meets DSM-5 criteria for Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, or Delusional Disorder.
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Ability to provide written informed consent
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Smoke ≥ 7 cigarettes per day
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Expired breath CO ≥ 10 ppm at screening
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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
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Alcohol or Substance Dependence past 3 months (caffeine allowed, nicotine is part of inclusion criteria).
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Pregnant or lactating
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Psychiatric hospitalization in past 3 months
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Suicidal and/or aggressive behavior past 3 months
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Implanted cardiac or brain medical devices
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Latex allergy
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Scalp irritation or recent shaving of scalp
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Use of other smoking cessation medication
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History of head trauma
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History of ECT
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- University of Pittsburgh
- National Institute on Drug Abuse (NIDA)
Investigators
- Principal Investigator: Cynthia Conklin, PhD, University of Pittsburgh
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- tDCS
- R21DA045137