Nicotine Dependance, Schizophrenia, Tobacco Use Disorder
Conditions
Keywords
schizophrenia, varenicline, cognition, cigarette smoking
Brief summary
This is an open label pre-post study of the effects of clinical treatment with varenicline on 1) decreasing smoking in schizophrenic patients, 2) improving selected cognitive measures in schizophrenic patients, and 3) psychopathology in schizophrenic patients. Patients are assessed on subjective and objective measures of smoking, selected cognitive measures, and special chemical measures, during baseline testing and during 8 weeks of treatment with varenicline (1-2 mg/day).
Interventions
DRUGVarenicline
Varenicline 1-2 mg/day
Sponsors
University of Illinois at Chicago
Nathan Kline Institute for Psychiatric Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Clinical Diagnosis of Schizophrenia or Schizoaffective Psychosis * Recent History of Cigarette smoking * Ages 18-65
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self Report of Smoking | Baseline and during 2 months of treatment | Patients self-report of smoking cigarettes. Patients were interviewed weekly about the number of cigarettes smoked. Number of cigarettes smoked in the past week. |
| CO (Carbon Monoxide) Breathalyzer Level | baseline and during 2 months of treatment | Carbon Monoxide in breath ,parts per million |
| Plasma Cotinine | baseline 1 month and 2 months | cotinine level in plasma ng/ml. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RBANS Neuropsychological Battery | baseline and month 2 of treatment | The scale is Repeatable Battery for the Assessment to Neuropsychological Status (RBANS). This scale measures cognitive function in patients with schizophrenia. RBANS scores for list learning range from 0 to 40. RBANS Index scores for visual-spatial index, language index, and Total score range from 40-160. RBANS Total score is the sum of score of all the individual items ( items 1-12) on the RBANS scale. List Learning scores range from 0 to 40. Visual Spatial Construction index scores range from 0 to 30.. Higher scores on all these measures indicate better performance or better cognitive ability. |
| Change From Baseline in Psychiatric Symptoms | Baseline and 2 months later | 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). Higher numbers indicate more psychopathology. Therefore, if scores are reduced at post-baseline ratings, this would indicate lower psychopathology. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Varenciline open label varenicline 2mg/day
Varenicline: Varenicline 1-2 mg/day | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Varenciline |
|---|---|
| Age, Continuous | 40.1 years STANDARD_DEVIATION 8.4 |
| Race/Ethnicity, Customized african american | 11 Participants |
| Race/Ethnicity, Customized hispanic | 2 Participants |
| Race/Ethnicity, Customized white | 1 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
CO (Carbon Monoxide) Breathalyzer Level
Carbon Monoxide in breath ,parts per million
Time frame: baseline and during 2 months of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Varenciline | CO (Carbon Monoxide) Breathalyzer Level | CO level baseline | 8.97 ppm (carbon monoxide parts per million) | Standard Deviation 6.21 |
| Varenciline | CO (Carbon Monoxide) Breathalyzer Level | CO level month 1 | 5.7 ppm (carbon monoxide parts per million) | Standard Deviation 4 |
| Varenciline | CO (Carbon Monoxide) Breathalyzer Level | CO level month 2 | 4.85 ppm (carbon monoxide parts per million) | Standard Deviation 4.41 |
Primary
Plasma Cotinine
cotinine level in plasma ng/ml.
Time frame: baseline 1 month and 2 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Varenciline | Plasma Cotinine | baseline cotinine | 362.25 ng/ml | Standard Deviation 120.93 |
| Varenciline | Plasma Cotinine | 1 month cotinine | 181.75 ng/ml | Standard Deviation 144.08 |
| Varenciline | Plasma Cotinine | 2 month cotinine | 200.25 ng/ml | Standard Deviation 129.75 |
Primary
Self Report of Smoking
Patients self-report of smoking cigarettes. Patients were interviewed weekly about the number of cigarettes smoked. Number of cigarettes smoked in the past week.
Time frame: Baseline and during 2 months of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Varenciline | Self Report of Smoking | Cigarettes smoked baseline | 36.45 Cigarettes | Standard Deviation 63.03 |
| Varenciline | Self Report of Smoking | Cigarettes smoked month 1 | 17.25 Cigarettes | Standard Deviation 29.74 |
| Varenciline | Self Report of Smoking | Cigarettes smoked month 2 | 12.52 Cigarettes | Standard Deviation 20.11 |
Secondary
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). Higher numbers indicate more psychopathology. Therefore, if scores are reduced at post-baseline ratings, this would indicate lower psychopathology.
Time frame: Baseline and 2 months later
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Varenciline | Change From Baseline in Psychiatric Symptoms | PANSS total 2 months | 55.58 Units on the PANSS scale | Standard Deviation 9.41 |
| Varenciline | Change From Baseline in Psychiatric Symptoms | PANSS total baseline | 56.57 Units on the PANSS scale | Standard Deviation 12.72 |
| Varenciline | Change From Baseline in Psychiatric Symptoms | PANSS Positive baseline | 12.58 Units on the PANSS scale | Standard Deviation 5.41 |
| Varenciline | Change From Baseline in Psychiatric Symptoms | PANSS Positive 2 months | 12.00 Units on the PANSS scale | Standard Deviation 5.59 |
Secondary
RBANS Neuropsychological Battery
The scale is Repeatable Battery for the Assessment to Neuropsychological Status (RBANS). This scale measures cognitive function in patients with schizophrenia. RBANS scores for list learning range from 0 to 40. RBANS Index scores for visual-spatial index, language index, and Total score range from 40-160. RBANS Total score is the sum of score of all the individual items ( items 1-12) on the RBANS scale. List Learning scores range from 0 to 40. Visual Spatial Construction index scores range from 0 to 30.. Higher scores on all these measures indicate better performance or better cognitive ability.
Time frame: baseline and month 2 of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Varenciline | RBANS Neuropsychological Battery | RBANS list learning 2 months | 19.50 RBANS scores | Standard Deviation 4.19 |
| Varenciline | RBANS Neuropsychological Battery | RBANS total baseline | 59.00 RBANS scores | Standard Deviation 13.1 |
| Varenciline | RBANS Neuropsychological Battery | RBANS total 2 months | 59.17 RBANS scores | Standard Deviation 9.26 |
| Varenciline | RBANS Neuropsychological Battery | RBANS l;ist learning baseline | 15.75 RBANS scores | Standard Deviation 5.5 |
| Varenciline | RBANS Neuropsychological Battery | RBANS visuospatal index baseline | 73.58 RBANS scores | Standard Deviation 7.44 |
| Varenciline | RBANS Neuropsychological Battery | RBANS visuospatial index 2 months | 63.50 RBANS scores | Standard Deviation 8.07 |
| Varenciline | RBANS Neuropsychological Battery | RBANS language index baseline | 70.17 RBANS scores | Standard Deviation 13.23 |
| Varenciline | RBANS Neuropsychological Battery | RBANS language index 2 months | 83.50 RBANS scores | Standard Deviation 12.55 |