A Phase 3 interventional study of placebo and varenicline (CP-526,555) in Smoking Cessation, sponsored by Pfizer. Completed at 14 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-04-15.
Sponsored by Pfizer · Phase 3 and Interventional
Study will determine whether patients with schizophrenia or schizoaffective disorder can be helped to quit smoking safely while using varenicline and receiving smoking cessation counseling.
This is a safety study.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 128 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Randomization 2:1 treatment to placebo
Drug: placebo
Drug: varenicline (CP-526,555)
Randomization 2:1 treatment to placebo
One week of titration up to 1mg bid and 11 weeks of dosing at 1mg bid
Also known as: Chantix, Champix
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs are any untoward medical occurrence in a clinical investigation participant administered a product or medical device. The event does not need to be causally related to the study treatment or usage. SAEs include any untoward medical occurrence that results in death, are life threatening, requires hospitalization or prolongation of hospitalization, results in disability or incapacity or are a congenital anomaly or birth defect in the offspring of a study participant. Lack of efficacy was to be reported as an AE when it was associated with an SAE.
Time frame: Baseline up to 30 days after last dose of study treatment or up to Week 16
Number of Participants With Psychiatric Adverse Events
Psychiatric Adverse Event symptoms included, but were not restricted to, depression, anxiety, hostility, perceptual / thinking disturbance, suicidal ideation, or suicidal behavior based on clinical judgment and use of the Positive and Negative Syndrome Scale and Columbia Classification Algorithm of Suicide assessments.
Time frame: Baseline up to Week 24
Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Total Score
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Total scores range from 30 to 210 with higher scores indicating more extreme symptoms.
Time frame: Baseline to Week 12
Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Total Score
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Total scores range from 30 to 210 with higher scores indicating more extreme symptoms.
Time frame: Baseline to Week 24
Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Positive symptoms (productive symptoms) associated with schizophrenia (delusions, conceptual disorganization, and hallucinatory behavior) are rated on a scale from 1 (absent) to 7 (extreme); total positive subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.
Time frame: Baseline to Week 12
Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Positive symptoms (productive symptoms) associated with schizophrenia (delusions, conceptual disorganization, and hallucinatory behavior) are rated on a scale from 1 (absent) to 7 (extreme); total positive subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.
Time frame: Baseline to Week 24
Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Negative symptoms (deficit features) associated with schizophrenia (blunted affect, emotional withdrawal, poor rapport, and passive / apathetic social withdrawal) are rated on a scale from 1 (absent) to 7 (extreme); total negative subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.
Time frame: Baseline to Week 12
Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Negative symptoms (deficit features) associated with schizophrenia (blunted affect, emotional withdrawal, poor rapport, and passive / apathetic social withdrawal) are rated on a scale from 1 (absent) to 7 (extreme); total negative subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.
Time frame: Baseline to Week 24
Change From Baseline to Week 12 in Simpson Angus Rating Scale (SARS)
10-item rating scale to assess the severity of extrapyramidal symptoms rated on a 5-point scale 0 (normal) to 4 (highest severity). Items measured are gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella tap, tremor, and salivation. Global score calculated by summing individual item scores and dividing by the total number of items; range is 0 to 40 with higher scores indicating greater severity.
Time frame: Baseline to Week 12
Change From Baseline to Week 24 in Simpson Angus Rating Scale (SARS)
10-item rating scale to assess the severity of extrapyramidal symptoms rated on a 5-point scale 0 (normal) to 4 (highest severity). Items measured are gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella tap, tremor, and salivation. Global score calculated by summing individual item scores and dividing by the total number of items; range is 0 to 40 with higher scores indicating greater severity.
Time frame: Baseline to Week 24
Number of Participants With Suicidal Behavior and / or Ideation ("Yes" Response) on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Treatment Phase
C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a "yes" response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a "yes" response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent).
Time frame: Week 1 to Week 12 (Treatment phase)
Number of Participants With Suicidal Behavior or Suicical Ideation ("Yes" Response ) on the Columbia Suicide-Severity Rating Scale (C-SSRS) During the Post Treatment Phase
C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a "yes" response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a "yes" response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent).
Time frame: Week 13 to Week 24 (Post treatment phase)
Number of Participants With Shift From Baseline to Week 12 in Clinical Global Impressions Scale-Severity (CGI-S) Score
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.
Time frame: Baseline (Bsl) to Week 12
Number of Participants With Shift From Baseline to Week 24 in Clinical Global Impressions Scale-Severity (CGI-S) Score
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.
Time frame: Baseline to Week 24
Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1
CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.
Time frame: Baseline, Week 1
Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12
CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.
Time frame: Baseline, Week 12
Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24
CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.
Time frame: Baseline, Week 24
Number of Participants With 7-day Point Prevalence of Non-smoking at Week 12
7-day point prevalence of non-smoking measured as the number of participants who maintained complete abstinence from cigarette smoking or other nicotine use in the previous 7 days before the Week 12 visit and had an end-expiratory carbon monoxide (CO) measurement of ≤10 parts per million (ppm).
Time frame: Week 12
Number of Participants With 7-day Point Prevalence of Non-smoking at Week 24
7-day point prevalence of non-smoking measured as the number of participants who maintained complete abstinence from cigarette smoking or other nicotine use in the previous 7 days before the Week 24 visit and had an end-expiratory carbon monoxide (CO) measurement of ≤10 parts per million (ppm).
Time frame: Week 24
Number of Participants With at Least a 50 Percent (%) Reduction From Baseline to Week 12 and Week 24 in the Number of Cigarettes Smoked Per Day
Measured as at least a 50% reduction from baseline in cigarettes smoked per day averaged over the past 7 days at Week 12 and Week 24.
Time frame: Baseline, Week 12, Week 24
Change From Baseline to Week 12 and Week 24 in the Number of Cigarettes Smoked Per Day
Measured as mean number of cigarettes smoked per day averaged over the past 7 days at Week 12 and Week 24.
Time frame: Baseline, Week 12, Week 24
| Milestone | Varenicline | Placebo |
|---|---|---|
| Started | 85 | 43 |
| Completed | 71 | 40 |
| Not completed | 14 | 3 |
| Withdrew: Randomized, not treated | 1 | 0 |
| Withdrew: Adverse event | 3 | 0 |
| Withdrew: Withdrawal by subject | 4 | 0 |
| Withdrew: Lost to follow-up | 2 | 2 |
| Withdrew: Other | 4 | 1 |
| Milestone | Varenicline | Placebo |
|---|---|---|
| Started | 71 | 40 |
| Completed | 61 | 37 |
| Not completed | 10 | 3 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Withdrawal by subject | 4 | 2 |
| Withdrew: Lost to follow-up | 4 | 1 |
| Withdrew: Other | 1 | 0 |
AEs are any untoward medical occurrence in a clinical investigation participant administered a product or medical device. The event does not need to be causally related to the study treatment or usage. SAEs include any untoward medical occurrence that results in death, are life threatening, requires hospitalization or prolongation of hospitalization, results in disability or incapacity or are a congenital anomaly or birth defect in the offspring of a study participant. Lack of efficacy was to be reported as an AE when it was associated with an SAE.
| participants | Varenicline | Placebo |
|---|---|---|
| Serious Adverse Events | 5 | 4 |
| Adverse Events | 70 | 35 |
Psychiatric Adverse Event symptoms included, but were not restricted to, depression, anxiety, hostility, perceptual / thinking disturbance, suicidal ideation, or suicidal behavior based on clinical judgment and use of the Positive and Negative Syndrome Scale and Columbia Classification Algorithm of Suicide assessments.
| participants | Varenicline | Placebo |
|---|---|---|
| Abnormal dreams | 6 | 4 |
| Aggression | 0 | 1 |
| Agitation | 0 | 1 |
| Anxiety | 4 | 4 |
| Depressed mood | 2 | 1 |
| Depression | 4 | 3 |
| Hallucination auditory | 4 | 1 |
| Hallucination visual | 1 | 0 |
| Initial insomnia | 1 | 0 |
| Insomnia | 8 | 2 |
| Nervousness | 1 | 0 |
| Nightmare | 1 | 0 |
| Panic reaction | 1 | 0 |
| Paranoia | 2 | 0 |
| Psychiatric symptom | 1 | 0 |
| Restlessness | 1 | 0 |
| Sleep disorder | 1 | 1 |
| Suicidal ideation | 5 | 3 |
| Suicide attempt | 1 | 0 |
| Tension | 1 | 0 |
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Total scores range from 30 to 210 with higher scores indicating more extreme symptoms.
| scores on a scale | Varenicline | Placebo |
|---|---|---|
| Baseline mean | 55.88 ± 9.5 | 54.47 ± 10.67 |
| Mean change at Week 12 (n=68, 39) | -5.19 ± 8.99 | -3.46 ± 7.52 |
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Total scores range from 30 to 210 with higher scores indicating more extreme symptoms.
| scores on a scale | Varenicline | Placebo |
|---|---|---|
| Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Total Score | -4.77 ± 10.63 | -3.27 ± 7.98 |
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Positive symptoms (productive symptoms) associated with schizophrenia (delusions, conceptual disorganization, and hallucinatory behavior) are rated on a scale from 1 (absent) to 7 (extreme); total positive subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.
| scores on a scale | Varenicline | Placebo |
|---|---|---|
| Baseline mean | 13.43 ± 3.23 | 13.53 ± 4.15 |
| Mean change at Week 12 (n=68, 39) | -1.87 ± 3.34 | -1.33 ± 2.83 |
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Positive symptoms (productive symptoms) associated with schizophrenia (delusions, conceptual disorganization, and hallucinatory behavior) are rated on a scale from 1 (absent) to 7 (extreme); total positive subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.
| scores on a scale | Varenicline | Placebo |
|---|---|---|
| Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score | -1.49 ± 3.8 | -1.68 ± 2.82 |
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Negative symptoms (deficit features) associated with schizophrenia (blunted affect, emotional withdrawal, poor rapport, and passive / apathetic social withdrawal) are rated on a scale from 1 (absent) to 7 (extreme); total negative subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.
| scores on a scale | Varenicline | Placebo |
|---|---|---|
| Baseline mean | 14.75 ± 4.12 | 14.79 ± 4.95 |
| Mean change at Week 12 (n=68, 39) | -1 ± 3.37 | -1.33 ± 2.97 |
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Negative symptoms (deficit features) associated with schizophrenia (blunted affect, emotional withdrawal, poor rapport, and passive / apathetic social withdrawal) are rated on a scale from 1 (absent) to 7 (extreme); total negative subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.
| scores on a scale | Varenicline | Placebo |
|---|---|---|
| Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score | -1.43 ± 3.68 | -0.68 ± 3.76 |
10-item rating scale to assess the severity of extrapyramidal symptoms rated on a 5-point scale 0 (normal) to 4 (highest severity). Items measured are gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella tap, tremor, and salivation. Global score calculated by summing individual item scores and dividing by the total number of items; range is 0 to 40 with higher scores indicating greater severity.
| scores on a scale | Varenicline | Placebo |
|---|---|---|
| Baseline mean | 1.452 ± 2.061 | 1.139 ± 1.846 |
| Mean change at Week 12 (n=68, 39) | -0.42 ± 1.341 | 0.102 ± 1.984 |
10-item rating scale to assess the severity of extrapyramidal symptoms rated on a 5-point scale 0 (normal) to 4 (highest severity). Items measured are gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella tap, tremor, and salivation. Global score calculated by summing individual item scores and dividing by the total number of items; range is 0 to 40 with higher scores indicating greater severity.
| scores on a scale | Varenicline | Placebo |
|---|---|---|
| Change From Baseline to Week 24 in Simpson Angus Rating Scale (SARS) | -0.37 ± 1.253 | -0.29 ± 1.221 |
C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a "yes" response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a "yes" response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent).
| participants | Varenicline | Placebo |
|---|---|---|
| Number of Participants With Suicidal Behavior and / or Ideation ("Yes" Response) on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Treatment Phase | 9 | 4 |
C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a "yes" response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a "yes" response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent).
| participants | Varenicline | Placebo |
|---|---|---|
| Number of Participants With Suicidal Behavior or Suicical Ideation ("Yes" Response ) on the Columbia Suicide-Severity Rating Scale (C-SSRS) During the Post Treatment Phase | 6 | 0 |
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.
| participants | Varenicline | Placebo |
|---|---|---|
| Mildly ill Bsl to Borderline ill Week 12 | 1 | 0 |
| Mildly ill Bsl to Moderately ill Week 12 | 1 | 1 |
| Moderately ill Bsl to Borderline ill Week 12 | 1 | 0 |
| Moderately ill Bsl to Mildly ill Week 12 | 4 | 1 |
| Markedly ill Bsl to Moderately ill Week 12 | 1 | 0 |
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.
| participants | Varenicline | Placebo |
|---|---|---|
| Mildly ill Bsl to Borderline ill Week 24 | 1 | 0 |
| Mildly ill Bsl to Moderately ill Week 24 | 1 | 1 |
| Mildly ill Bsl to Markedly ill Week 24 | 1 | 0 |
| Moderately ill Bsl to Borderline ill Week 24 | 1 | 0 |
| Moderately ill Bsl to Mildly ill Week 24 | 5 | 1 |
| Markedly ill Bsl to Moderately ill Week 24 | 1 | 0 |
CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.
| participants | Varenicline | Placebo |
|---|---|---|
| Very much improved | 0 | 0 |
| Much improved | 3 | 0 |
| Minimally improved | 4 | 3 |
| No change | 67 | 37 |
| Minimally worse | 5 | 3 |
| Much worse | 0 | 0 |
| Very much worse | 0 | 0 |
CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.
| participants | Varenicline | Placebo |
|---|---|---|
| Very much improved | 1 | 0 |
| Much improved | 1 | 0 |
| Minimally improved | 5 | 4 |
| No change | 55 | 35 |
| Minimally worse | 6 | 0 |
| Much worse | 0 | 0 |
| Very much worse | 0 | 0 |
CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.
| participants | Varenicline | Placebo |
|---|---|---|
| Very much improved | 2 | 0 |
| Much improved | 2 | 1 |
| Minimally improved | 8 | 5 |
| No change | 46 | 31 |
| Minimally worse | 2 | 0 |
| Much worse | 1 | 0 |
| Very much worse | 0 | 0 |
7-day point prevalence of non-smoking measured as the number of participants who maintained complete abstinence from cigarette smoking or other nicotine use in the previous 7 days before the Week 12 visit and had an end-expiratory carbon monoxide (CO) measurement of ≤10 parts per million (ppm).
| participants | Varenicline | Placebo |
|---|---|---|
| Number of Participants With 7-day Point Prevalence of Non-smoking at Week 12 | 16 | 2 |
7-day point prevalence of non-smoking measured as the number of participants who maintained complete abstinence from cigarette smoking or other nicotine use in the previous 7 days before the Week 24 visit and had an end-expiratory carbon monoxide (CO) measurement of ≤10 parts per million (ppm).
| participants | Varenicline | Placebo |
|---|---|---|
| Number of Participants With 7-day Point Prevalence of Non-smoking at Week 24 | 10 | 1 |
Measured as at least a 50% reduction from baseline in cigarettes smoked per day averaged over the past 7 days at Week 12 and Week 24.
| participants | Varenicline | Placebo |
|---|---|---|
| Week 12 | 54 | 22 |
| Week 24 | 34 | 18 |
Measured as mean number of cigarettes smoked per day averaged over the past 7 days at Week 12 and Week 24.
| cigarettes per day | Varenicline | Placebo |
|---|---|---|
| Week 12 (n=68, 39) | -14.23 (-15.95 to -12.51) | -10.58 (-12.73 to -8.42) |
| Week 24 (n=61, 37) | -9.55 (-12.00 to -7.10) | -9.32 (-12.36 to -6.28) |
Collected over Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Varenicline | — | 5/84 (6%) | 48/84 (57.1%) |
| Placebo | — | 4/43 (9.3%) | 25/43 (58.1%) |
| Event | Varenicline | Placebo |
|---|---|---|
| HyperglycaemiaMetabolism and nutrition disorders | 0/84 | 1/43 |
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/84 | 1/43 |
| AggressionPsychiatric disorders | 0/84 | 1/43 |
| Suicidal ideationPsychiatric disorders | 1/84 | 1/43 |
| Chest painGeneral disorders | 1/84 | 0/43 |
| ConvulsionNervous system disorders | 1/84 | 0/43 |
| DepressionPsychiatric disorders | 1/84 | 0/43 |
| Psychiatric symptomPsychiatric disorders | 1/84 | 0/43 |
| Suicide attemptPsychiatric disorders | 1/84 | 0/43 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 1/84 | 0/43 |
| Event | Varenicline | Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 20/84 | 6/43 |
| HeadacheNervous system disorders | 9/84 | 8/43 |
| VomitingGastrointestinal disorders | 9/84 | 4/43 |
| InsomniaPsychiatric disorders | 8/84 | 2/43 |
| Abnormal dreamsPsychiatric disorders | 6/84 | 4/43 |
| AnxietyPsychiatric disorders | 4/84 | 4/43 |
| Abdominal pain upperGastrointestinal disorders | 7/84 | 1/43 |
| DiarrhoeaGastrointestinal disorders | 7/84 | 2/43 |
| Upper respiratory tract infectionInfections and infestations | 6/84 | 1/43 |
| IrritabilityGeneral disorders | 5/84 | 3/43 |
| Age, Customized(participants) | Varenicline | Placebo | Total |
|---|---|---|---|
| 18 to 34 years | 33 | 11 | 44 |
| 35 to 44 years | 10 | 9 | 19 |
| 45 to 64 years | 42 | 23 | 65 |
| Sex: Female, Male(Participants) | Varenicline | Placebo | Total |
|---|---|---|---|
| Female | 20 | 10 | 30 |
| Male | 65 | 33 | 98 |
| Number of participants with suicidal behavior and / or ideation on Columbia Suicide Severity Rating(participants) | Varenicline | Placebo | Total |
|---|---|---|---|
| Number | 0 | 1 | 1 |
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