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Varenicline Effects In Schizophrenic Smokers

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ClinicalTrials.gov Identifier: NCT00548470
Recruitment Status : Completed
First Posted : October 24, 2007
Results First Posted : September 5, 2017
Last Update Posted : September 20, 2018
Sponsor:
Collaborator:
University of Illinois at Chicago
Information provided by (Responsible Party):
Robert C. Smith MD PhD, Nathan Kline Institute for Psychiatric Research

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Schizophrenia
Tobacco Use Disorder
Nicotine Dependance
Intervention Drug: Varenicline
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Varenciline
Hide Arm/Group Description

open label varenicline 2mg/day

Varenicline: Varenicline 1-2 mg/day

Period Title: Overall Study
Started 14
Completed 12
Not Completed 2
Arm/Group Title Varenciline
Hide Arm/Group Description

open label varenicline 2mg/day

Varenicline: Varenicline 1-2 mg/day

Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
40.1  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
0
   0.0%
Male
14
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
white
1
   7.1%
african american
11
  78.6%
hispanic
2
  14.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
1.Primary Outcome
Title Self Report of Smoking
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenciline
Hide Arm/Group Description:

open label varenicline 2mg/day

Varenicline: Varenicline 1-2 mg/day

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: Cigarettes
Cigarettes smoked baseline 36.45  (63.03)
Cigarettes smoked month 1 17.25  (29.74)
Cigarettes smoked month 2 12.52  (20.11)
2.Primary Outcome
Title CO (Carbon Monoxide) Breathalyzer Level
Hide Description Carbon Monoxide in breath ,parts per million
Time Frame baseline and during 2 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenciline
Hide Arm/Group Description:

open label varenicline 2mg/day

Varenicline: Varenicline 1-2 mg/day

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ppm (carbon monoxide parts per million)
CO level baseline 8.97  (6.21)
CO level month 1 5.7  (4.00)
CO level month 2 4.85  (4.41)
3.Primary Outcome
Title Plasma Cotinine
Hide Description cotinine level in plasma ng/ml.
Time Frame baseline 1 month and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenciline
Hide Arm/Group Description:

open label varenicline 2mg/day

Varenicline: Varenicline 1-2 mg/day

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ng/ml
baseline cotinine 362.25  (120.93)
1 month cotinine 181.75  (144.08)
2 month cotinine 200.25  (129.75)
4.Secondary Outcome
Title RBANS Neuropsychological Battery
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenciline
Hide Arm/Group Description:

open label varenicline 2mg/day

Varenicline: Varenicline 1-2 mg/day

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: RBANS scores
RBANS total baseline 59.00  (13.10)
RBANS total 2 months 59.17  (9.26)
RBANS l;ist learning baseline 15.75  (5.50)
RBANS list learning 2 months 19.50  (4.19)
RBANS visuospatal index baseline 73.58  (7.44)
RBANS visuospatial index 2 months 63.50  (8.07)
RBANS language index baseline 70.17  (13.23)
RBANS language index 2 months 83.50  (12.55)
5.Secondary Outcome
Title Change From Baseline in Psychiatric Symptoms
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenciline
Hide Arm/Group Description:

open label varenicline 2mg/day

Varenicline: Varenicline 1-2 mg/day

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: Units on the PANSS scale
PANSS total baseline 56.57  (12.72)
PANSS total 2 months 55.58  (9.41)
PANSS Positive baseline 12.58  (5.41)
PANSS Positive 2 months 12.00  (5.59)
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Varenicline
Hide Arm/Group Description

open label varenicline 2mg/day

Varenicline: Varenicline 1-2 mg/day

All-Cause Mortality
Varenicline
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Varenicline
Affected / at Risk (%) # Events
Total   0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Varenicline
Affected / at Risk (%) # Events
Total   2/14 (14.29%)    
Gastrointestinal disorders   
nausea * [1]  2/14 (14.29%)  2
*
Indicates events were collected by non-systematic assessment
[1]
nausea reported on varenicline
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Robert C Smith MD
Organization: Nathan Kline Institute for psychaitric Research
Phone: 845-398-6531
Responsible Party: Robert C. Smith MD PhD, Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier: NCT00548470     History of Changes
Other Study ID Numbers: 06I/C34-0
First Submitted: October 22, 2007
First Posted: October 24, 2007
Results First Submitted: December 17, 2016
Results First Posted: September 5, 2017
Last Update Posted: September 20, 2018