Transcranial Direct Current StimulationTACTICSSNCT03588728
tDCS and Cognitive Training Intervention for Chronic Smokers With Schizophrenia
A study testing Transcranial Direct Current Stimulation and Cognitive Remediation (CR) in people with Transcranial Direct Current Stimulation and Smoking, Cigarette, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Transcranial Direct Current Stimulation, Smoking, Cigarette, Schizophrenia
- What is being tested?
- Transcranial Direct Current Stimulation and Cognitive Remediation (CR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2018to 12 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- Latex allergy
- Scalp irritation or recent shaving of scalp
- Use of other smoking cessation medication
- History of head trauma
- History of ECT
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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.
- Being tested
- Transcranial Direct Current Stimulation, Cognitive Remediation (CR)
- Keywords
- Transcranial Direct Current Stimulation, Smoking, Schizophrenia
- Medical subject headings
- Cigarette Smoking, Schizophrenia, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationOther
Also called tDCS
Transcranial direct current stimulation targeting the right inferior frontal gyrus
Cognitive Remediation (CR)Behavioural
Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
| Study group | Role | What they receive |
|---|---|---|
| CR + tDCS | Experimental | Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS) Receives: Other: Transcranial Direct Current Stimulation; Behavioral: Cognitive Remediation (CR) |
| CR + sham tDCS | Sham comparator | Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS) Receives: Behavioral: Cognitive Remediation (CR) |
| control CR + tDCS | Sham comparator | Control Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS) Receives: Other: Transcranial Direct Current Stimulation |
| control CR + sham tDCS | No intervention | Control Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to approximately 4 weeks
Secondary outcomes (10)
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.
Measured: Baseline to approximately 4 weeks
Cigarette Puff Volume
Change in mean cigarette puff volume
Measured: Baseline and at approximately 4 weeks
Latency to First Cigarette Puff
Change in mean latency to first cigarette puff
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to approximately 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start23 Jul 2018
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Why it stopped: Lab was shut down due to COVID as were nearing study completion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Transcranial Direct Current StimulationStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2 (CR, Control CR) x 2 (tDCS xSham tDCS)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Cynthia Conklin, University of Pittsburgh
- Investigators
- Cynthia Conklin, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588728
- Sponsor's protocol ID
- tDCS
- Other IDs
- R21DA045137
- Acronym
- TACTICSS
- Status last verified
- Dec 2022
- First submitted
- 3 Jul 2018
- Last updated
- 13 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- tDCS and Cognitive Training Intervention for Chronic Smokers With Schizophrenia
- ClinicalTrials.gov ID
- NCT03588728
- Acronym / sponsor ID
- TACTICSS / tDCS
- Keywords
- Transcranial Direct Current Stimulation, Smoking, Schizophrenia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lab was shut down due to COVID as were nearing study completion
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 17 Jul 2018 (actual)
- Results
- Posted 13 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 2 (CR, Control CR) x 2 (tDCS xSham tDCS)
| Arm | Type | Receives |
|---|---|---|
| CR + tDCS | Experimental | Other: Transcranial Direct Current Stimulation, Behavioral: Cognitive Remediation (CR)Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS) |
| CR + sham tDCS | Sham comparator | Behavioral: Cognitive Remediation (CR)Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS) |
| control CR + tDCS | Sham comparator | Other: Transcranial Direct Current StimulationControl 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulationAlso: tDCSTranscranial direct current stimulation targeting the right inferior frontal gyrus | Other | CR + tDCS, control CR + tDCS |
| Cognitive Remediation (CR)Cognitive exercises on a computer designed to increase attention, memory, and processing speed. | Behavioural | CR + sham tDCS, CR + tDCS |
Primary outcome
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.
10 secondary outcomes
Cue-Reactivity
Time frame: Baseline to approximately 4 weeks
Cigarette Puff Volume
Time frame: Baseline and at approximately 4 weeks
Latency to First Cigarette Puff
Time frame: 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 Continuous Performance Task (AX-CPT) Reaction Time Variability
Time frame: Baseline to approximately 4 weeks
EEG (Electroencephalogram) N170 Amplitude
Time frame: Baseline to approximately 4 weeks
EEG (Electroencephalogram) Contingent Negative Variation (CNV)
Time frame: Baseline to approximately 4 weeks
EEG (Electroencephalogram) Beta-Band Event-Related Desynchronization (ERD)
Time frame: Baseline to approximately 4 weeks
Attention & Smoking Cue Exposure Task (ASCET)
Time frame: Baseline to approximately 4 weeks
Total Number of Puffs
Time frame: Baseline to approximately 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Conklin, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation and Cognitive Remediation (CR) in people with Transcranial Direct Current Stimulation and Smoking, Cigarette, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS™): MATRICS Consensus Cognitive Battery (MCCB) (time frame: Baseline to approximately 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.