tDCS and Cognitive Training Intervention for Chronic Smokers With Schizophrenia (TACTICSS)
Primary Purpose
Transcranial Direct Current Stimulation, Smoking, Cigarette, Schizophrenia
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Cognitive Remediation (CR)
Sponsored by
About this trial
This is an interventional treatment trial for Transcranial Direct Current Stimulation focused on measuring Transcranial Direct Current Stimulation, Smoking, Schizophrenia
Eligibility Criteria
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
Sites / Locations
- University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Sham Comparator
Sham Comparator
No Intervention
Arm Label
CR + tDCS
CR + sham tDCS
control CR + tDCS
control CR + sham tDCS
Arm Description
Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
Control Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Control Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
Outcomes
Primary Outcome Measures
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS™): MATRICS Consensus Cognitive Battery (MCCB)
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.
Secondary Outcome Measures
Cue-Reactivity
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.
Cigarette Puff Volume
Change in mean cigarette puff volume
Latency to First Cigarette Puff
Change in mean latency to first cigarette puff
AX Version of the Continuous Performance Task (AX-CPT) Reaction Time
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)
AX Version of the Continuous Performance Task (AX-CPT) Reaction Time Variability
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.
EEG (Electroencephalogram) N170 Amplitude
Difference in change scores (post minus pre-intervention) in N170 Amplitude between smoking and neutral images. A more negative score indicates greater improvement.
EEG (Electroencephalogram) Contingent Negative Variation (CNV)
Difference in CNV between the A and X in the AX-CPT Task. More negative indicates larger CNV.
EEG (Electroencephalogram) Beta-Band Event-Related Desynchronization (ERD)
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.
Attention & Smoking Cue Exposure Task (ASCET)
Post minus Pre-intervention difference in Reaction time between smoking and neutral images presented with the ASCET task. A negative RT indicates improvement.
Total Number of Puffs
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.
Full Information
NCT ID
NCT03588728
First Posted
July 3, 2018
Last Updated
February 15, 2023
Sponsor
University of Pittsburgh
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT03588728
Brief Title
tDCS and Cognitive Training Intervention for Chronic Smokers With Schizophrenia
Acronym
TACTICSS
Official Title
tDCS and Cognitive Training Intervention for Chronic Smokers With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Lab was shut down due to COVID as were nearing study completion
Study Start Date
July 23, 2018 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
March 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transcranial Direct Current Stimulation, Smoking, Cigarette, Schizophrenia
Keywords
Transcranial Direct Current Stimulation, Smoking, Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
2 (CR, Control CR) x 2 (tDCS xSham tDCS)
Masking
Participant
Masking Description
Participants were not informed of their randomization group until debreifing.
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CR + tDCS
Arm Type
Experimental
Arm Description
Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Arm Title
CR + sham tDCS
Arm Type
Sham Comparator
Arm Description
Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
Arm Title
control CR + tDCS
Arm Type
Sham Comparator
Arm Description
Control Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Arm Title
control CR + sham tDCS
Arm Type
No Intervention
Arm Description
Control Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
Intervention Type
Other
Intervention Name(s)
Transcranial Direct Current Stimulation
Other Intervention Name(s)
tDCS
Intervention Description
Transcranial direct current stimulation targeting the right inferior frontal gyrus
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Remediation (CR)
Intervention Description
Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
Primary Outcome Measure Information:
Title
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS™): MATRICS Consensus Cognitive Battery (MCCB)
Description
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.
Time Frame
Baseline to approximately 4 weeks
Secondary Outcome Measure Information:
Title
Cue-Reactivity
Description
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.
Time Frame
Baseline to approximately 4 weeks
Title
Cigarette Puff Volume
Description
Change in mean cigarette puff volume
Time Frame
Baseline and at approximately 4 weeks
Title
Latency to First Cigarette Puff
Description
Change in mean latency to first cigarette puff
Time Frame
Baseline to approximately 4 weeks
Title
AX Version of the Continuous Performance Task (AX-CPT) Reaction Time
Description
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)
Time Frame
Baseline to approximately 4 weeks
Title
AX Version of the Continuous Performance Task (AX-CPT) Reaction Time Variability
Description
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.
Time Frame
Baseline to approximately 4 weeks
Title
EEG (Electroencephalogram) N170 Amplitude
Description
Difference in change scores (post minus pre-intervention) in N170 Amplitude between smoking and neutral images. A more negative score indicates greater improvement.
Time Frame
Baseline to approximately 4 weeks
Title
EEG (Electroencephalogram) Contingent Negative Variation (CNV)
Description
Difference in CNV between the A and X in the AX-CPT Task. More negative indicates larger CNV.
Time Frame
Baseline to approximately 4 weeks
Title
EEG (Electroencephalogram) Beta-Band Event-Related Desynchronization (ERD)
Description
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.
Time Frame
Baseline to approximately 4 weeks
Title
Attention & Smoking Cue Exposure Task (ASCET)
Description
Post minus Pre-intervention difference in Reaction time between smoking and neutral images presented with the ASCET task. A negative RT indicates improvement.
Time Frame
Baseline to approximately 4 weeks
Title
Total Number of Puffs
Description
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.
Time Frame
Baseline to approximately 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Conklin, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
tDCS and Cognitive Training Intervention for Chronic Smokers With Schizophrenia
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