Trial Outcomes & Findings for Varenicline Effects In Schizophrenic Smokers (NCT NCT00548470)

NCT ID: NCT00548470

Last Updated: 2018-09-20

Results Overview

Patients self-report of smoking cigarettes. Patients were interviewed weekly about the number of cigarettes smoked. Number of cigarettes smoked in the past week.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 14 participants
• Primary outcome timeframe: Baseline and during 2 months of treatment
• Results posted on: 2018-09-20

Participant Flow

Participant milestones

Measure	Varenciline open label varenicline 2mg/day Varenicline: Varenicline 1-2 mg/day
Overall Study STARTED	14
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Varenicline Effects In Schizophrenic Smokers

Baseline characteristics by cohort

Measure	Varenciline n=14 Participants open label varenicline 2mg/day Varenicline: Varenicline 1-2 mg/day
Age, Continuous	40.1 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race/Ethnicity, Customized white	1 Participants n=5 Participants
Race/Ethnicity, Customized african american	11 Participants n=5 Participants
Race/Ethnicity, Customized hispanic	2 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Varenciline n=12 Participants open label varenicline 2mg/day Varenicline: Varenicline 1-2 mg/day
Self Report of Smoking Cigarettes smoked baseline	36.45 Cigarettes Standard Deviation 63.03
Self Report of Smoking Cigarettes smoked month 1	17.25 Cigarettes Standard Deviation 29.74
Self Report of Smoking Cigarettes smoked month 2	12.52 Cigarettes Standard Deviation 20.11

PRIMARY outcome

Timeframe: baseline and during 2 months of treatment

Carbon Monoxide in breath ,parts per million

Outcome measures

Measure	Varenciline n=12 Participants open label varenicline 2mg/day Varenicline: Varenicline 1-2 mg/day
CO (Carbon Monoxide) Breathalyzer Level CO level baseline	8.97 ppm (carbon monoxide parts per million) Standard Deviation 6.21
CO (Carbon Monoxide) Breathalyzer Level CO level month 1	5.7 ppm (carbon monoxide parts per million) Standard Deviation 4.00
CO (Carbon Monoxide) Breathalyzer Level CO level month 2	4.85 ppm (carbon monoxide parts per million) Standard Deviation 4.41

PRIMARY outcome

Timeframe: baseline 1 month and 2 months

cotinine level in plasma ng/ml.

Outcome measures

Measure	Varenciline n=12 Participants open label varenicline 2mg/day Varenicline: Varenicline 1-2 mg/day
Plasma Cotinine baseline cotinine	362.25 ng/ml Standard Deviation 120.93
Plasma Cotinine 1 month cotinine	181.75 ng/ml Standard Deviation 144.08
Plasma Cotinine 2 month cotinine	200.25 ng/ml Standard Deviation 129.75

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Varenciline n=12 Participants open label varenicline 2mg/day Varenicline: Varenicline 1-2 mg/day
RBANS Neuropsychological Battery RBANS total baseline	59.00 RBANS scores Standard Deviation 13.10
RBANS Neuropsychological Battery RBANS total 2 months	59.17 RBANS scores Standard Deviation 9.26
RBANS Neuropsychological Battery RBANS l;ist learning baseline	15.75 RBANS scores Standard Deviation 5.50
RBANS Neuropsychological Battery RBANS list learning 2 months	19.50 RBANS scores Standard Deviation 4.19
RBANS Neuropsychological Battery RBANS visuospatal index baseline	73.58 RBANS scores Standard Deviation 7.44
RBANS Neuropsychological Battery RBANS visuospatial index 2 months	63.50 RBANS scores Standard Deviation 8.07
RBANS Neuropsychological Battery RBANS language index baseline	70.17 RBANS scores Standard Deviation 13.23
RBANS Neuropsychological Battery RBANS language index 2 months	83.50 RBANS scores Standard Deviation 12.55

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Varenciline n=12 Participants open label varenicline 2mg/day Varenicline: Varenicline 1-2 mg/day
Change From Baseline in Psychiatric Symptoms PANSS total baseline	56.57 Units on the PANSS scale Standard Deviation 12.72
Change From Baseline in Psychiatric Symptoms PANSS total 2 months	55.58 Units on the PANSS scale Standard Deviation 9.41
Change From Baseline in Psychiatric Symptoms PANSS Positive baseline	12.58 Units on the PANSS scale Standard Deviation 5.41
Change From Baseline in Psychiatric Symptoms PANSS Positive 2 months	12.00 Units on the PANSS scale Standard Deviation 5.59

Adverse Events

Varenicline

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Varenicline n=14 participants at risk open label varenicline 2mg/day Varenicline: Varenicline 1-2 mg/day
Gastrointestinal disorders nausea	14.3% 2/14 • Number of events 2 • 12 weeks

Additional Information

Robert C Smith MD

Nathan Kline Institute for psychaitric Research

Phone: 845-398-6531

Email: rsmith@nki.rfmh.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place