Trial Outcomes & Findings for EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking (NCT NCT03262662)
NCT ID: NCT03262662
Last Updated: 2025-09-26
Results Overview
Number of participants with bio-verified (cotinine level of 15 ng/mL or less) self-reported continuous abstinence from smoking (not even a puff) during the final four weeks of treatment
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
320 participants
Primary outcome timeframe
Self-report Treatment Weeks 12-15; bio-verification ~Week 16
Results posted on
2025-09-26
Participant Flow
Participant milestones
| Measure |
Extended Run-In
\*\* 4 weeks of varenicline prior to the target quit date (TQD) \*\*
\+ 11 weeks of post-TQD varenicline
Standard varenicline dosing titration in initial week of therapy (one 0.5 mg tablet orally daily x 3 days, then one 0.5 mg tablet twice daily x 4 days); then 1 mg twice daily thereafter.
Brief individual counseling at clinic visits
Varenicline: oral varenicline tablets
Brief smoking cessation counseling: \~10-minute individual counseling at each of 6 clinic visits
|
Standard Run-In
\*\* 3 weeks of placebo followed by 1 week of varenicline prior to the target quit date (TQD) \*\*
\+ 11 weeks of post-TQD varenicline
Standard varenicline dosing titration in initial week of therapy (one 0.5 mg tablet orally daily x 3 days, then one 0.5 mg tablet twice daily x 4 days); then 1 mg twice daily thereafter.
Brief individual counseling at clinic visits
Varenicline: oral varenicline tablets
Brief smoking cessation counseling: \~10-minute individual counseling at each of 6 clinic visits
|
|---|---|---|
|
Overall Study
STARTED
|
163
|
157
|
|
Overall Study
Retained at Wk 15 (EOT)
|
127
|
126
|
|
Overall Study
Retained at Wk 28 (6-month Follow-up)
|
124
|
121
|
|
Overall Study
COMPLETED
|
163
|
157
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Baseline cotinine data were missing for one participant in the standard run-in group.
Baseline characteristics by cohort
| Measure |
Extended Run-In
n=163 Participants
\*\* 4 weeks of varenicline prior to the target quit date (TQD) \*\*
\+ 11 weeks of post-TQD varenicline
Standard varenicline dosing titration in initial week of therapy (one 0.5 mg tablet orally daily x 3 days, then one 0.5 mg tablet twice daily x 4 days); then 1 mg twice daily thereafter.
Brief individual counseling at clinic visits
Varenicline: oral varenicline tablets
Brief smoking cessation counseling: \~10-minute individual counseling at each of 6 clinic visits
|
Standard Run-In
n=157 Participants
\*\* 3 weeks of placebo followed by 1 week of varenicline prior to the target quit date (TQD) \*\*
\+ 11 weeks of post-TQD varenicline
Standard varenicline dosing titration in initial week of therapy (one 0.5 mg tablet orally daily x 3 days, then one 0.5 mg tablet twice daily x 4 days); then 1 mg twice daily thereafter.
Brief individual counseling at clinic visits
Varenicline: oral varenicline tablets
Brief smoking cessation counseling: \~10-minute individual counseling at each of 6 clinic visits
|
Total
n=320 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
90 Participants
n=163 Participants
|
89 Participants
n=157 Participants
|
179 Participants
n=320 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=163 Participants
|
68 Participants
n=157 Participants
|
141 Participants
n=320 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=163 Participants
|
4 Participants
n=157 Participants
|
8 Participants
n=320 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
159 Participants
n=163 Participants
|
153 Participants
n=157 Participants
|
312 Participants
n=320 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=163 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=320 Participants
|
|
Age, Continuous
|
53.8 years
STANDARD_DEVIATION 10.3 • n=163 Participants
|
53.5 years
STANDARD_DEVIATION 10 • n=157 Participants
|
53.7 years
STANDARD_DEVIATION 10.1 • n=320 Participants
|
|
Race/Ethnicity, Customized
Race · White/Caucasian
|
122 Participants
n=163 Participants
|
118 Participants
n=157 Participants
|
240 Participants
n=320 Participants
|
|
Race/Ethnicity, Customized
Race · Black/African American
|
33 Participants
n=163 Participants
|
34 Participants
n=157 Participants
|
67 Participants
n=320 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian / Alaska Native
|
1 Participants
n=163 Participants
|
2 Participants
n=157 Participants
|
3 Participants
n=320 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
4 Participants
n=163 Participants
|
3 Participants
n=157 Participants
|
7 Participants
n=320 Participants
|
|
Race/Ethnicity, Customized
Race · More than 1 race
|
2 Participants
n=163 Participants
|
0 Participants
n=157 Participants
|
2 Participants
n=320 Participants
|
|
Race/Ethnicity, Customized
Race · Refused / prefer not to answer
|
1 Participants
n=163 Participants
|
0 Participants
n=157 Participants
|
1 Participants
n=320 Participants
|
|
Region of Enrollment
United States
|
163 participants
n=163 Participants
|
157 participants
n=157 Participants
|
320 participants
n=320 Participants
|
|
Cigarettes per day
|
17.9 Cigarettes per day
STANDARD_DEVIATION 7.2 • n=163 Participants
|
18.4 Cigarettes per day
STANDARD_DEVIATION 7.3 • n=157 Participants
|
18.1 Cigarettes per day
STANDARD_DEVIATION 7.2 • n=320 Participants
|
|
Salivary cotinine
|
312 ng/mL
STANDARD_DEVIATION 158 • n=163 Participants • Baseline cotinine data were missing for one participant in the standard run-in group.
|
312 ng/mL
STANDARD_DEVIATION 164 • n=156 Participants • Baseline cotinine data were missing for one participant in the standard run-in group.
|
312 ng/mL
STANDARD_DEVIATION 161 • n=319 Participants • Baseline cotinine data were missing for one participant in the standard run-in group.
|
PRIMARY outcome
Timeframe: Self-report Treatment Weeks 12-15; bio-verification ~Week 16Population: Intent-to-treat analysis.
Number of participants with bio-verified (cotinine level of 15 ng/mL or less) self-reported continuous abstinence from smoking (not even a puff) during the final four weeks of treatment
Outcome measures
| Measure |
Extended Run-In
n=163 Participants
\*\* 4 weeks of varenicline prior to the target quit date (TQD) \*\*
\+ 11 weeks of post-TQD varenicline
Standard varenicline dosing titration in initial week of therapy (one 0.5 mg tablet orally daily x 3 days, then one 0.5 mg tablet twice daily x 4 days); then 1 mg twice daily thereafter.
Brief individual counseling at clinic visits
Varenicline: oral varenicline tablets
Brief smoking cessation counseling: \~10-minute individual counseling at each of 6 clinic visits
|
Standard Run-In
n=157 Participants
\*\* 3 weeks of placebo followed by 1 week of varenicline prior to the target quit date (TQD) \*\*
\+ 11 weeks of post-TQD varenicline
Standard varenicline dosing titration in initial week of therapy (one 0.5 mg tablet orally daily x 3 days, then one 0.5 mg tablet twice daily x 4 days); then 1 mg twice daily thereafter.
Brief individual counseling at clinic visits
Varenicline: oral varenicline tablets
Brief smoking cessation counseling: \~10-minute individual counseling at each of 6 clinic visits
|
|---|---|---|
|
Number of Participants With Continuous Abstinence at End-of-Treatment (EOT) as Assessed by Self-Report and Bio-verification
|
64 Participants
|
57 Participants
|
SECONDARY outcome
Timeframe: Treatment Week 1 vs. Treatment Week 4 (final week before TQD)Population: This analysis is not based on ITT, as only participants with complete TLFB data for Weeks 1 and 4 were included in the analysis; early in the trial, pre-quit TLFB was not consistently obtained due to staff error.
Percent change in smoking behavior (self-reported cigarettes per day; CPD) from timeline follow-back (TLFB) interviews during the pre-quit phase of the study.
Outcome measures
| Measure |
Extended Run-In
n=128 Participants
\*\* 4 weeks of varenicline prior to the target quit date (TQD) \*\*
\+ 11 weeks of post-TQD varenicline
Standard varenicline dosing titration in initial week of therapy (one 0.5 mg tablet orally daily x 3 days, then one 0.5 mg tablet twice daily x 4 days); then 1 mg twice daily thereafter.
Brief individual counseling at clinic visits
Varenicline: oral varenicline tablets
Brief smoking cessation counseling: \~10-minute individual counseling at each of 6 clinic visits
|
Standard Run-In
n=123 Participants
\*\* 3 weeks of placebo followed by 1 week of varenicline prior to the target quit date (TQD) \*\*
\+ 11 weeks of post-TQD varenicline
Standard varenicline dosing titration in initial week of therapy (one 0.5 mg tablet orally daily x 3 days, then one 0.5 mg tablet twice daily x 4 days); then 1 mg twice daily thereafter.
Brief individual counseling at clinic visits
Varenicline: oral varenicline tablets
Brief smoking cessation counseling: \~10-minute individual counseling at each of 6 clinic visits
|
|---|---|---|
|
Pre-quit Change in Cigarettes Smoked Per Day
|
-38.8 percent change in CPD
Standard Error 2.7
|
-17.5 percent change in CPD
Standard Error 2.8
|
SECONDARY outcome
Timeframe: Self-report Treatment Weeks 12-28; bio-verification ~Week 16 and ~Week 29Number of participants with continuous abstinence at the 6-month follow-up (no self-reported smoking during weeks 12-28 AND cotinine level 15 ng/mL or less at EOT and 6 month follow-up)
Outcome measures
| Measure |
Extended Run-In
n=163 Participants
\*\* 4 weeks of varenicline prior to the target quit date (TQD) \*\*
\+ 11 weeks of post-TQD varenicline
Standard varenicline dosing titration in initial week of therapy (one 0.5 mg tablet orally daily x 3 days, then one 0.5 mg tablet twice daily x 4 days); then 1 mg twice daily thereafter.
Brief individual counseling at clinic visits
Varenicline: oral varenicline tablets
Brief smoking cessation counseling: \~10-minute individual counseling at each of 6 clinic visits
|
Standard Run-In
n=157 Participants
\*\* 3 weeks of placebo followed by 1 week of varenicline prior to the target quit date (TQD) \*\*
\+ 11 weeks of post-TQD varenicline
Standard varenicline dosing titration in initial week of therapy (one 0.5 mg tablet orally daily x 3 days, then one 0.5 mg tablet twice daily x 4 days); then 1 mg twice daily thereafter.
Brief individual counseling at clinic visits
Varenicline: oral varenicline tablets
Brief smoking cessation counseling: \~10-minute individual counseling at each of 6 clinic visits
|
|---|---|---|
|
Number of Participants With Continuous Abstinence at 6-Month Follow-Up as Assessed by Self-Report and Bio-verification
|
37 Participants
|
29 Participants
|
Adverse Events
Pre-Treatment Phase (Intake Visit & Clinic 1): Extended Run-In Group
Serious events: 0 serious events
Other events: 125 other events
Deaths: 0 deaths
Pre-Treatment Phase (Intake Visit & Clinic 1): Standard Run-In Group
Serious events: 0 serious events
Other events: 121 other events
Deaths: 0 deaths
Pre-Quit Run-In Manip Phase (Clinic 2 & 3): Extended Run-In Group
Serious events: 1 serious events
Other events: 131 other events
Deaths: 0 deaths
Pre-Quit Run-In Manip Phase (Clinic 2 & 3): Standard Run-In Group
Serious events: 0 serious events
Other events: 104 other events
Deaths: 0 deaths
Early Quit Phase (Clinic 4 & 5): Extended Run-In Group
Serious events: 2 serious events
Other events: 116 other events
Deaths: 0 deaths
Early Quit Phase (Clinic 4 & 5): Standard Run-In Group
Serious events: 2 serious events
Other events: 104 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pre-Treatment Phase (Intake Visit & Clinic 1): Extended Run-In Group
n=163 participants at risk
Pre-Treatment Phase: Intake Visit and Clinic 1 assessments occurred prior to initiating treatment
Brief smoking cessation counseling: \~10-minute individual counseling at each clinic visit
|
Pre-Treatment Phase (Intake Visit & Clinic 1): Standard Run-In Group
n=157 participants at risk
Pre-Treatment Phase: Intake Visit and Clinic 1 assessments occurred prior to initiating treatment
Brief smoking cessation counseling: \~10-minute individual counseling at each clinic visit
|
Pre-Quit Run-In Manip Phase (Clinic 2 & 3): Extended Run-In Group
n=157 participants at risk
Pre-Quit Run-In Manipulation Phase (3 weeks):
All participants began taking study medication following Clinic 1
The extended run-in group took varenicline:
Varenicline dosing titration in initial week of therapy (one 0.5 mg tablet orally daily x 3 days, then one 0.5 mg tablet twice daily x 4 days); then 1 mg twice daily thereafter.
Brief smoking cessation counseling: \~10-minute individual counseling at each clinic visit
|
Pre-Quit Run-In Manip Phase (Clinic 2 & 3): Standard Run-In Group
n=147 participants at risk
Pre-Quit Run-In Manipulation Phase (3 weeks):
All participants began taking study medication following Clinic 1
The standard run-in group took placebo.
Brief smoking cessation counseling: \~10-minute individual counseling at each clinic visit
|
Early Quit Phase (Clinic 4 & 5): Extended Run-In Group
n=150 participants at risk
Early Quit Phase (3 weeks):
The extended run-in group continued varenicline, two 0.5 mg varenicline twice daily during Week 4 (to match the placebo group and maintain the blind); 1 mg twice daily thereafter.
Brief smoking cessation counseling: \~10-minute individual counseling at each clinic visit
|
Early Quit Phase (Clinic 4 & 5): Standard Run-In Group
n=146 participants at risk
Early Quit Phase (3 weeks)
Varenicline dosing titration in Week 4 (one 0.5 mg tablet and 3 placebo orally daily x 3 days, then one 0.5 mg tablet and 1 placebo twice daily x 4 days); then 1 mg twice daily thereafter.
Brief smoking cessation counseling: \~10-minute individual counseling at each clinic visit
|
|---|---|---|---|---|---|---|
|
Renal and urinary disorders
pyelonephritis/nephrolithiasis
|
0.00%
0/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.00%
0/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.00%
0/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.00%
0/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.00%
0/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.68%
1/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
Renal and urinary disorders
urinary tract infection
|
0.00%
0/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.00%
0/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.00%
0/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.00%
0/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.67%
1/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.00%
0/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
Skin and subcutaneous tissue disorders
Scabies
|
0.00%
0/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.00%
0/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.00%
0/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.00%
0/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.67%
1/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.00%
0/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
Cardiac disorders
Bilateral hand swelling
|
0.00%
0/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.00%
0/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.00%
0/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.00%
0/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.00%
0/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.68%
1/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
Gastrointestinal disorders
bowel obstruction/laparotomy for lysis of adhesions
|
0.00%
0/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.00%
0/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.64%
1/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.00%
0/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.00%
0/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.00%
0/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
Musculoskeletal and connective tissue disorders
urinary frequency and incisional pain 3 days after elective inguinal hernia repair
|
0.00%
0/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.00%
0/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.00%
0/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.00%
0/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.67%
1/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
0.00%
0/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
Other adverse events
| Measure |
Pre-Treatment Phase (Intake Visit & Clinic 1): Extended Run-In Group
n=163 participants at risk
Pre-Treatment Phase: Intake Visit and Clinic 1 assessments occurred prior to initiating treatment
Brief smoking cessation counseling: \~10-minute individual counseling at each clinic visit
|
Pre-Treatment Phase (Intake Visit & Clinic 1): Standard Run-In Group
n=157 participants at risk
Pre-Treatment Phase: Intake Visit and Clinic 1 assessments occurred prior to initiating treatment
Brief smoking cessation counseling: \~10-minute individual counseling at each clinic visit
|
Pre-Quit Run-In Manip Phase (Clinic 2 & 3): Extended Run-In Group
n=157 participants at risk
Pre-Quit Run-In Manipulation Phase (3 weeks):
All participants began taking study medication following Clinic 1
The extended run-in group took varenicline:
Varenicline dosing titration in initial week of therapy (one 0.5 mg tablet orally daily x 3 days, then one 0.5 mg tablet twice daily x 4 days); then 1 mg twice daily thereafter.
Brief smoking cessation counseling: \~10-minute individual counseling at each clinic visit
|
Pre-Quit Run-In Manip Phase (Clinic 2 & 3): Standard Run-In Group
n=147 participants at risk
Pre-Quit Run-In Manipulation Phase (3 weeks):
All participants began taking study medication following Clinic 1
The standard run-in group took placebo.
Brief smoking cessation counseling: \~10-minute individual counseling at each clinic visit
|
Early Quit Phase (Clinic 4 & 5): Extended Run-In Group
n=150 participants at risk
Early Quit Phase (3 weeks):
The extended run-in group continued varenicline, two 0.5 mg varenicline twice daily during Week 4 (to match the placebo group and maintain the blind); 1 mg twice daily thereafter.
Brief smoking cessation counseling: \~10-minute individual counseling at each clinic visit
|
Early Quit Phase (Clinic 4 & 5): Standard Run-In Group
n=146 participants at risk
Early Quit Phase (3 weeks)
Varenicline dosing titration in Week 4 (one 0.5 mg tablet and 3 placebo orally daily x 3 days, then one 0.5 mg tablet and 1 placebo twice daily x 4 days); then 1 mg twice daily thereafter.
Brief smoking cessation counseling: \~10-minute individual counseling at each clinic visit
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.0%
13/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
8.3%
13/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
28.7%
45/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
17.7%
26/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
32.0%
48/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
28.8%
42/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
Gastrointestinal disorders
Vomiting
|
0.61%
1/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
1.3%
2/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
7.0%
11/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
3.4%
5/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
6.7%
10/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
6.2%
9/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.9%
8/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
5.7%
9/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
12.1%
19/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
5.4%
8/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
8.7%
13/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
8.2%
12/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
Gastrointestinal disorders
Indigestion
|
10.4%
17/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
8.3%
13/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
8.3%
13/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
4.1%
6/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
6.7%
10/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
6.2%
9/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
Gastrointestinal disorders
Diarrhea
|
7.4%
12/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
8.3%
13/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
8.3%
13/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
4.8%
7/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
8.0%
12/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
3.4%
5/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
Gastrointestinal disorders
Constipation
|
9.8%
16/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
7.0%
11/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
14.0%
22/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
15.6%
23/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
16.7%
25/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
19.2%
28/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
Gastrointestinal disorders
Dry mouth
|
15.3%
25/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
23.6%
37/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
21.0%
33/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
29.3%
43/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
19.3%
29/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
25.3%
37/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
Gastrointestinal disorders
Flatulence
|
1.8%
3/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
9.6%
15/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
7.0%
11/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
10.2%
15/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
8.0%
12/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
6.8%
10/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
Gastrointestinal disorders
Gas
|
11.7%
19/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
14.6%
23/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
17.8%
28/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
13.6%
20/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
16.7%
25/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
15.8%
23/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
Psychiatric disorders
Agitation
|
22.7%
37/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
19.7%
31/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
20.4%
32/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
17.7%
26/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
19.3%
29/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
28.1%
41/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
Psychiatric disorders
Depressed Mood
|
12.3%
20/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
17.2%
27/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
13.4%
21/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
10.9%
16/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
15.3%
23/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
9.6%
14/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
Psychiatric disorders
Irritability
|
35.6%
58/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
31.8%
50/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
35.0%
55/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
32.0%
47/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
32.7%
49/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
38.4%
56/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
Psychiatric disorders
Hostility
|
5.5%
9/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
1.3%
2/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
6.4%
10/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
3.4%
5/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
7.3%
11/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
4.1%
6/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
Psychiatric disorders
Anxiety
|
22.1%
36/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
21.7%
34/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
16.6%
26/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
17.0%
25/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
16.7%
25/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
21.9%
32/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
General disorders
Insomnia
|
15.3%
25/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
18.5%
29/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
18.5%
29/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
18.4%
27/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
22.0%
33/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
19.9%
29/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
General disorders
Abnormal dreams
|
3.7%
6/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
5.7%
9/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
26.1%
41/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
10.2%
15/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
23.3%
35/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
16.4%
24/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
General disorders
Other Sleep Problems
|
14.1%
23/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
18.5%
29/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
15.9%
25/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
9.5%
14/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
14.7%
22/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
10.3%
15/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
Cardiac disorders
Increased Heart Rate
|
6.7%
11/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
1.9%
3/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
5.1%
8/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
4.8%
7/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
3.3%
5/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
2.7%
4/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
Cardiac disorders
Chest Pain
|
5.5%
9/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
3.8%
6/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
5.7%
9/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
3.4%
5/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
4.7%
7/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
2.7%
4/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
Nervous system disorders
Headache
|
23.9%
39/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
29.9%
47/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
19.7%
31/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
26.5%
39/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
17.3%
26/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
19.9%
29/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
Nervous system disorders
Dizziness
|
8.0%
13/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
6.4%
10/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
14.0%
22/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
6.1%
9/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
8.0%
12/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
6.2%
9/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
Nervous system disorders
Attention Disturbance
|
2.5%
4/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
6.4%
10/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
6.4%
10/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
4.1%
6/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
2.7%
4/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
6.8%
10/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
General disorders
Fatigue
|
23.9%
39/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
27.4%
43/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
17.8%
28/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
22.4%
33/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
18.7%
28/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
21.9%
32/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
|
General disorders
Weakness
|
8.6%
14/163 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
5.7%
9/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
5.1%
8/157 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
4.8%
7/147 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
5.3%
8/150 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
6.8%
10/146 • Adverse events were assessed at intake and clinic visits which occurred across the first two months of treatment.
At each visit, participants completed a 32-item symptom checklist, as in prior work. Suicidality was assessed at each visit with the Columbia Suicide Severity Rating Scale. Here, data on adverse events are reported for each of three treatment phasesphases (pre-treatment phase \[intake visit \& clinic visit 1); pre-quit run-in manipulation phase \[clinic visits 2\&3; extended run-in group taking varenicline, standard run-in group taking placebo\], and early quit phase \[clinic visits 4\&5\]).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place