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| ID | Type | Description | Link |
|---|---|---|---|
| R21DA045137 | U.S. NIH Grant/Contract | View source |
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Lab was shut down due to COVID as were nearing study completion
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CR + tDCS | Experimental | Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS) |
|
| CR + sham tDCS | Sham Comparator | Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS) |
|
| control CR + tDCS | Sham Comparator | Control Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS) |
|
| control CR + sham tDCS | No Intervention | Control Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation | Other | Transcranial direct current stimulation targeting the right inferior frontal gyrus |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to approximately 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to approximately 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Conklin, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | CR + tDCS | Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS) Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed. |
| FG001 | CR + Sham tDCS | Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS) Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed. |
| FG002 | Control CR + tDCS | Control Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS) Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus |
| FG003 | Control CR + Sham tDCS | Control Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
These number reflect participants who completed the study. 3 of 10 participants in CR + tDCS did not complete. 3 of 12 participants in control + tDCS did not complete. 3 of 11 participants in CR + tDCS did not complete. Total from Study Flow = 39 with 30 Completers
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| ID | Title | Description |
|---|---|---|
| BG000 | CR + tDCS | Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS) Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to approximately 4 weeks |
|
Participants were assessed for adverse events from the time they completed informed content to the end of their participation in the study, which was approximately 4 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CR + tDCS | Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS) Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Illness not related to study participation | Infections and infestations | Non-systematic Assessment | Participant was hospitalized Briefly due to illness not related to study participation. |
Study was unexpectedly shut down prior to completing recruitment due to COVID-19 protocols.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Conklin, Ph.D. | University of Pittsburgh | 4125869840 | conkca@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 12, 2018 | Nov 14, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D012559 | Schizophrenia |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D000072466 | Cognitive Remediation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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2 (CR, Control CR) x 2 (tDCS xSham tDCS)
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Participants were not informed of their randomization group until debreifing.
|
| Cognitive Remediation (CR) | Behavioral | Cognitive exercises on a computer designed to increase attention, memory, and processing speed. |
|
| Cigarette Puff Volume |
Change in mean cigarette puff volume |
| Baseline and at approximately 4 weeks |
| Latency to First Cigarette Puff | Change in mean latency to first cigarette puff | Baseline to approximately 4 weeks |
| 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) | Baseline to approximately 4 weeks |
| 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. | Baseline to approximately 4 weeks |
| 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. | Baseline to approximately 4 weeks |
| EEG (Electroencephalogram) Contingent Negative Variation (CNV) | 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) | 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) | 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 | 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 |
| Lab shut down due to COVID-19 |
|
| multiple technical issues |
|
| Hospitalized for COVID |
|
| Schedule change unable to attend sessions |
|
| BG001 |
| CR + Sham tDCS |
Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS) Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed. |
| BG002 | Control CR + tDCS | Control Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS) Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus |
| BG003 | Control CR + Sham tDCS | Control Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS) |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Nicotine Dependence Score | Level of dependence measured 0-7 with a higher score indicating more nicotine dependence. | Mean | Standard Deviation | units on a scale |
|
| OG001 | CR + Sham tDCS | Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS) Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed. |
| OG002 | Control CR + tDCS | Control Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS) Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus |
| OG003 | Control CR + Sham tDCS | Control Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS) |
|
|
|
| Secondary | 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. | Three subjects were removed from analyses due to misunderstanding the computerized rating system. | Posted | Mean | Standard Deviation | score on a scale | Baseline to approximately 4 weeks |
|
|
|
|
| Secondary | Cigarette Puff Volume | Change in mean cigarette puff volume | Participants who did not smoke at baseline during cue reactivity were excluded from the analyses. This included 1 from arm CR + tDCS, 2 from CR + sham tDCS, and 2 from control CR + tDCS. | Posted | Mean | Standard Deviation | Milliliters | Baseline and at approximately 4 weeks |
|
|
|
|
| Secondary | Latency to First Cigarette Puff | Change in mean latency to first cigarette puff | Participants who did not smoke at baseline during cue reactivity were excluded from this analysis. This included 1 from arm CR + tDCS, 2 from CR + sham tDCS, and 2 from control CR + tDCS. | Posted | Mean | Standard Deviation | seconds | Baseline to approximately 4 weeks |
|
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | milliseconds | Baseline to approximately 4 weeks |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | milliseconds | Baseline to approximately 4 weeks |
|
|
|
|
| Secondary | 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. | Subjects were removed from analysis if their data was too noisy from excessive coughing or moving around. | Posted | Mean | Standard Deviation | microvolts | Baseline to approximately 4 weeks |
|
|
|
|
| Secondary | EEG (Electroencephalogram) Contingent Negative Variation (CNV) | Difference in CNV between the A and X in the AX-CPT Task. More negative indicates larger CNV. | Subjects were removed from analysis if their data was too noisy from excessive coughing or moving around. | Posted | Mean | Standard Deviation | microvolts | Baseline to approximately 4 weeks |
|
|
|
|
| Secondary | 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. | Subjects were removed from analysis if their data was too noisy from excessive coughing or moving around. | Posted | Mean | Standard Deviation | microvolts squared | Baseline to approximately 4 weeks |
|
|
|
|
| Secondary | 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. | The baseline data for one subject in CR + tDCS did not save. | Posted | Mean | Standard Deviation | milliseconds | Baseline to approximately 4 weeks |
|
|
|
|
| Secondary | 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. | Participants who did not smoke at baseline during cue reactivity were excluded from this analysis. This included 1 from arm CR + tDCS, 2 from CR + sham tDCS, and 2 from control CR + tDCS. | Posted | Mean | Standard Deviation | puffs | Baseline to approximately 4 weeks |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | CR + Sham tDCS | Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS) Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Control CR + tDCS | Control Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS) Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus | 0 | 12 | 0 | 12 | 0 | 12 |
| EG003 | Control CR + Sham tDCS | Control Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS) | 0 | 11 | 0 | 11 | 0 | 11 |
|
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| D001523 | Mental Disorders |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |