Cigarette Smoking, Cognition, Schizophrenia
Conditions
Keywords
Schizophrenia, Cigarette smoking, Cognition, Craving, MATRICS
Brief summary
This is a study of the effects of tDCS on smoking, craving for cigarettes, cognition, and psychiatric symptoms in schizophrenic patients who are current smokers or have a history of regular cigarette smoking. It assesses smoking with CO monitoring, nicotine and nicotine levels, and craving with QSU scale and response to craving slides. Cognition is measured by MCCB, symptoms are measured by PANSS and hallucination scale. This is a double-blind sham-controlled study with active tDCS 2ma or 20 minutes over 5 days, and sham tDCS for 40 seconds on each sham occasion.
Interventions
DEVICEtDCS
Transcranial Direct Current Stimulation
Sponsors
Nathan Kline Institute for Psychiatric Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of schizophrenia spectrum disorder History of cigarette smoking
Exclusion criteria
* Seizure disorder or current treated neurological illness Current Acute exacerbation of psychotic state
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Cigarette Craving | Baseline and after 5 tDCs sessions (mean time 8.7[SD 2.7] days after basleine) | The Brief Questionnaire on Smoking Urges (QSU-Brief) was used to measure cigarette cravings. Scores ranged from a minimum of 1 (Strongly Disagree) to a maximum of 7 (Strongly Agree) and were determined by self-reported responses to 10 statements about having cravings for smoking. Scores closer to 1 after treatment would indicate a better outcome. Responses to each of the 10 items in the scale were summed for one total score. With 10 items on this scale with a range of scores from 1 to 7, on each occasion of rating the minimum score would be 7 and the maximum score would be 70. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Cognitive Performance | Baseline and 1-3 days (mean 1.8 [SD 1.4] days after 5 tDCS sessions( mean 8.7 days after baseline) | The MATRICS Consensus Cognitive Battery (MCCB) was used to measure cognitive performance. Seven Domain scores and a Composite score are calculated by the proprietary MCCB Computer Scoring Program from raw scores on 10 individually administered subtests. We used the revised MCCB program (beta version) which allows for calculation of Domain and Composite scores with missing data. The Domain T-scores are percentile-ranked and range from \<20 (\<0.1 percentile) to \>80 (\>99.9 percentile). The Composite scores are also percentile-ranked and range from \<213 (T\<20, \<0.1 percentile) to \>487 (T\>80, \>99.9 percentile). Higher scores after baseline represent better outcomes. Here we report difference scores from post-treatment and baseline with positive difference scores representing better outcomes. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Psychiatric Symptoms | Baseline and after 5 tDCS sessions | The Positive and Negative Syndrome Scale (PANSS) was used to measure psychiatric symptoms. Item scores ranged from 1 (Absent) to 6 (Severe) for symptoms on the Positive Scale (total subscale range: 7-42), the Negative Scale (total subscale range: 7-42), and the General Psychopathology Scale (total subscale range:16-96). All three subscales were summed for the PANSS total score (total scale range: 30-180). Scores closer to 30 after baseline represented better outcomes. Here we report difference scores from post-treatment and baseline with negative difference scores representing better outcomes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active tDCS tDCS 2ma for 20 min with anode at DLPFC once a day for 5 days
tDCS: Transcranial Direct Current Stimulation | 17 |
| Sham tDCS tDCS 2 ma for 40 second s with anode at DLPFC for 5 days
tDCS: Transcranial Direct Current Stimulation | 16 |
| Total | 33 |
Baseline characteristics
| Characteristic | Active tDCS | Sham tDCS | Total |
|---|---|---|---|
| Age, Continuous | 46.7 years STANDARD_DEVIATION 11.1 | 44.9 years STANDARD_DEVIATION 9.2 | 45.9 years STANDARD_DEVIATION 10.1 |
| Race/Ethnicity, Customized race/ethnicity black-African american | 10 Participants | 9 Participants | 19 Participants |
| Race/Ethnicity, Customized race/ethnicity hispanic | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized race/ethnicity other | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized race/ethnicity white | 6 Participants | 4 Participants | 10 Participants |
| Region of Enrollment United States | 17 participants | 16 participants | 33 participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Male | 14 Participants | 10 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 16 |
| serious Total, serious adverse events | 0 / 17 | 0 / 16 |
Outcome results
Primary
Change From Baseline in Cigarette Craving
The Brief Questionnaire on Smoking Urges (QSU-Brief) was used to measure cigarette cravings. Scores ranged from a minimum of 1 (Strongly Disagree) to a maximum of 7 (Strongly Agree) and were determined by self-reported responses to 10 statements about having cravings for smoking. Scores closer to 1 after treatment would indicate a better outcome. Responses to each of the 10 items in the scale were summed for one total score. With 10 items on this scale with a range of scores from 1 to 7, on each occasion of rating the minimum score would be 7 and the maximum score would be 70.
Time frame: Baseline and after 5 tDCs sessions (mean time 8.7[SD 2.7] days after basleine)
Population: Findings are based on31 subjects (15 active tDCS and 16 sham tDCS) who completed this QSU-Brief questionnaire in at baseline and after 5 tDCS sessions.. Complete sample who entered study and were randomized were 33 subjects 24 male and 9 female, but all subjects did not complete QSU brief rating scale..
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS | Change From Baseline in Cigarette Craving | 14.40 Units on QSU-Brief Scale | Standard Error 3.57 |
| Sham tDCS | Change From Baseline in Cigarette Craving | 11.00 Units on QSU-Brief Scale | Standard Error 3.45 |
Secondary
Change From Baseline in Cognitive Performance
The MATRICS Consensus Cognitive Battery (MCCB) was used to measure cognitive performance. Seven Domain scores and a Composite score are calculated by the proprietary MCCB Computer Scoring Program from raw scores on 10 individually administered subtests. We used the revised MCCB program (beta version) which allows for calculation of Domain and Composite scores with missing data. The Domain T-scores are percentile-ranked and range from \<20 (\<0.1 percentile) to \>80 (\>99.9 percentile). The Composite scores are also percentile-ranked and range from \<213 (T\<20, \<0.1 percentile) to \>487 (T\>80, \>99.9 percentile). Higher scores after baseline represent better outcomes. Here we report difference scores from post-treatment and baseline with positive difference scores representing better outcomes.
Time frame: Baseline and 1-3 days (mean 1.8 [SD 1.4] days after 5 tDCS sessions( mean 8.7 days after baseline)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Active tDCS | Change From Baseline in Cognitive Performance | MATRICS Composite Diff Score | 3.47 MATRICS domain difference scores | Standard Deviation 4.09 |
| Active tDCS | Change From Baseline in Cognitive Performance | MATRICS Working Memory Diff Score | 4.04 MATRICS domain difference scores | Standard Deviation 5.7 |
| Active tDCS | Change From Baseline in Cognitive Performance | MATRICS Attention/Vigilance Diff Score | 4.25 MATRICS domain difference scores | Standard Deviation 7.17 |
| Sham tDCS | Change From Baseline in Cognitive Performance | MATRICS Composite Diff Score | -0.85 MATRICS domain difference scores | Standard Deviation 4.08 |
| Sham tDCS | Change From Baseline in Cognitive Performance | MATRICS Working Memory Diff Score | -3.29 MATRICS domain difference scores | Standard Deviation 5.68 |
| Sham tDCS | Change From Baseline in Cognitive Performance | MATRICS Attention/Vigilance Diff Score | -1.91 MATRICS domain difference scores | Standard Deviation 7.17 |
Other Pre-specified
Change From Baseline in Psychiatric Symptoms
The Positive and Negative Syndrome Scale (PANSS) was used to measure psychiatric symptoms. Item scores ranged from 1 (Absent) to 6 (Severe) for symptoms on the Positive Scale (total subscale range: 7-42), the Negative Scale (total subscale range: 7-42), and the General Psychopathology Scale (total subscale range:16-96). All three subscales were summed for the PANSS total score (total scale range: 30-180). Scores closer to 30 after baseline represented better outcomes. Here we report difference scores from post-treatment and baseline with negative difference scores representing better outcomes.
Time frame: Baseline and after 5 tDCS sessions
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Active tDCS | Change From Baseline in Psychiatric Symptoms | PANSS total diff score | -1.51 Units on a scale | Standard Deviation 8.01 |
| Active tDCS | Change From Baseline in Psychiatric Symptoms | PANSS postive diff score | -1.70 Units on a scale | Standard Deviation 3.1 |
| Active tDCS | Change From Baseline in Psychiatric Symptoms | PANSS Negative diff score | 1.06 Units on a scale | Standard Deviation 4.38 |
| Sham tDCS | Change From Baseline in Psychiatric Symptoms | PANSS total diff score | -2.37 Units on a scale | Standard Deviation 8.01 |
| Sham tDCS | Change From Baseline in Psychiatric Symptoms | PANSS postive diff score | -1.63 Units on a scale | Standard Deviation 3.1 |
| Sham tDCS | Change From Baseline in Psychiatric Symptoms | PANSS Negative diff score | 0.68 Units on a scale | Standard Deviation 4.38 |