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. 2016 May 9;2016(5):CD006103. doi: 10.1002/14651858.CD006103.pub7
Study MNWS or WSWS QSU‐B Total Craving score mCEQ (for smokers)
Carson 2014
(wk 1)
1.0 mg bid vs placebo
At week 1, Likert scale:
Craving: V: 3.36; placebo: 4.45
Anxiety: V: 3.19; placebo: 4.25
Confidence: V: 7.95; placebo: 7.02
Motivation: V: 8.22; placebo: 7.50
 
Gonzales 2006
(wks 1 ‐ 7)
1.0 mg bid vs placebo
  Urge to smoke:  ‐0.54 (P < .001)  ES: ‐0.57*N Negative affect:  ‐0.19 (P < .001) ES: ‐0.30 Restlessness: ‐0.14 (P < .01)  ES: ‐0.16 Increased appetite: +0.12 (P = .04)  ES: 0.15 Insomnia: +0.05 (P = .36)  ES: 0.06  
 
‐0.45  (1.69 V, 2.13 P); P < 0.001; ES: ‐0.33
 
Baseline to wk 1: diff in changes between V&P: Smoking satisfaction: ‐0.60  (P < .001) ES: ‐0.47 Psych Reward: ‐0.50 (P < .001) ES: ‐0.37 Enjoy resp tract: ‐0.34 (P < .001) ES: ‐0.21 Craving reduction: ‐0.52 (P < .001) ES: ‐0.33 Aversion: ‐0.18 (P = .053) ES: ‐0.19
 
 
Jorenby 2006
(wks 1 ‐ 7)
1.0 mg bid vs placebo
 
Diff in mean change in: Urge to smoke:  ‐0.48 (P < .001) Negative affect:  ‐0.13 (P = 0.001) Restlessness:‐0.10(P = 0.05) Increased appetite: +0.07 (P = 0.22)  Insomnia: +0.10 (P = 0.07) 
 
‐0.44 ; (P < .001) [Factor 1 (pleasure) ‐0.56; (P < .001) Factor 2 (negative affect relief) ‐0.27 (P < .001)]
 
Baseline to wk 1: diff in changes between V&P: Smoking satisfaction: ‐0.44  (P < .001) Psych Reward: ‐0.32 (P < .001) Enjoy resp tract: ‐0.22 (P = 0.01) Craving reduction: ‐0.25 (P = 0.04) Aversion: 0 (P = 0.96)
 
 
Nides 2006
(wks 1 ‐ 7)
1.0 mg bid vs placebo
 
Diff in mean change in: Urge to smoke:  wk 1 ‐1.14; wk 2 ‐1.19; wk 3 ‐1.57; wk 4 ‐1.81; wk 5 ‐1.88; wk 6 ‐2.04; wk 7 ‐1.61(P < .001 for wks 1 ‐ 6, P < .01 wk 7)
 
Total score: wk 1 ‐7.00; wk 2 ‐10.71; wk 3 ‐12.72; wk 4 ‐14.08; wk 5 ‐13.24; wk 6 ‐14.94; wk 7 ‐14.38 (wks 1, 3, 5 P < .001, wks 2, 4, 6, 7 P < .01)
Baseline to wk 1: diff in changes between V&P: Smoking satisfaction: ‐1.62 Psych Reward: ‐0.35 Enjoy resp tract: ‐0.29 Craving reduction: ‐0.13 Aversion:‐0.79
 
Oncken 2006
(MNWS: wks 1 ‐ 12; mCEQ wks 1 ‐ 7)
1.0 mg bid vs placebo
 
Diff in mean change in Urge to Smoke score (extrapolated from graph): Wk 7: ‐0.2, Wk 12 ‐0.5; (P < .001 for both)
   
Baseline to wk 7: diff in changes between V&P: (extrapolated from graph) Smoking satisfaction: ‐1.3 (P < 0.01) Psych reward: ‐2.2 (P < 0.001)
Enjoy resp tract: ‐0.6 (P < 0.001)
 
 
Tonstad 2006
1.0 mg bid vs placebo
 
Diff in mean change in Urge to Smoke score (extrapolated from graph): All participants: Wk 13: ‐0.35, Wk 25 ‐0.25; Abstainers only:  Wk 13: ‐0.30, Wk 25 +0.02
 
   
 
 
Tsai 2007
(wks 1 ‐ 6)
1.0 mg bid vs placebo
 
 
Diff in mean change in Urge to Smoke: Wks 1 ‐ 6: ‐0.40 (P < 0.001)
 
Mean total score, wks 1 ‐ 6: ‐0.39 (P < 0.001)
 
 
Mean diff wks 1 ‐ 6:  V vs P: Smoking satisfaction: ‐0.39 (P < 0.008)
 
Nakamura 2007
(wks 1 ‐ 7)
1.0 mg bid vs placebo
(Nicotine‐dependent group only)
 
Diff in mean change in: Urge to Smoke score: ‐0.51 (P < 0.001) Negative Affect score: ‐0.28 (P < 0.001) Restlessness score: ‐0.38 (P < 0.001) Appetite+ score: ‐0.09 (P = 0.481) Insomnia score: 0.56 (P = 0.380)
 
Mean total score: ‐0.51 (P < 0.001) Factor 1 [pleasure] mean diff: ‐0.60 (P < 0.001) Factor 2 [negative affect] mean diff: ‐0.38 (P < 0.001)
 
Mean diff wks 1 ‐ 7:  V vs P: Smoking satisfaction: ‐0.74 (P < 0.001) Psych reward: ‐0.53 (P < 0.001) Enjoy resp tract: ‐1.00 (P < 0.001) Craving reduction: ‐0.45 (P < 0.001)
Aversion:‐0.38 (P < 0.0007)
 
Steinberg 2011
1.0 mg bid vs placebo
At 4 wks, Varenicline group had score of ‐1.45, placebo +0.11
 
Aubin 2008
(wks 1 ‐ 7)
1.0 mg bid vs NRT
 
 
Diff in mean change in: Urge to Smoke score: ‐0.32 (P < 0.001); E.S. ‐0.37 Negative Affect score: ‐0.16 (P < 0.001); E.S. ‐0.21 Restlessness score: ‐0.20 (P < 0.001); E.S. ‐0.21 Appetite + score: 0.09 (P = 0.116); E.S. 0.12 Insomnia score: ‐0.07 (P = 0.207); E.S. ‐0.07
 
   
Mean diff wks 1 ‐ 7:  V vs NRT: Smoking satisfaction: ‐0.54 (P < 0.001); E.S. ‐0.43 Psych reward: ‐0.32 (P = 0.001) E.S. ‐0.26 Enjoy resp tract: ‐0.39 (P < 0.001); E.S. ‐0.25 Craving reduction: ‐0.52 (P < 0.001); E.S. ‐0.32 Aversion: ‐0.07 (P = 0.436); E.S. 0.08
Niaura 2008
1 ‐ 4 x 0.5 mg ad lib
Diff in Urge to smoke, all pts: Wk 1: ‐0.4; Wk 2: ‐0.4; Wk 3 ‐0.6; Wk 4 ‐0.5; Wk 5 ‐0.6; Wk 6 ‐0.5; Wk 7 ‐0.4; Wk 12 ‐0.6.
Diff in withdrawal, all pts: Wk 1: ‐0.4; Wk 2: ‐0.7; Wk 3 ‐0.7; Wk 4 ‐1.1; Wk 5 ‐0.3; Wk 6 ‐0.4; Wk 7 ‐0.2; Wk 12 ‐0.9.
Diff in changes between V&P:
Smoking satisfaction:   Enjoy resp tract: Wk 1 ‐0.1; Wk 2 ‐0.3; Wk 3 ‐0.4; Wk 4 ‐0.5; Wk 5 ‐0.5; Wk 6 ‐0.5; Wk 7 ‐0.4
Tsukahara 2010
1.0 mg bid vs NRT
Diff in withdrawal score (all symptoms), V vs NRT: Wk 2 2.36; Wk 4 0.64; Wk 8 0.78; Wk 12 0.08
Cinciripini 2013 Significantly higher reward score (∼ 3.8) in placebo relapsers than in varenicline relapsers (∼ 2.7; P = 0.01)
(extrapolated from graph)
Evins 2014 WSWS measured over 12 wks open‐label varenicline:
Total score: Baseline:59.9 ‐ wk 12: 50.77
Urge to smoke: Baseline: 11.85 ‐ wk12: 8.2 Irritability: Baseline: 5.62 ‐ wk 12: 4.46
Depression: Baseline: 6.61 ‐ wk 12: 5.8
Increased appetite: Baseline: 11.79 ‐ wk 12: 11.88
Difficulty concentrating: Baseline: 5.86 ‐ wk 12: 5.15
Insomnia: Baseline: 8.52 ‐ wk 12: 8.25
Anxiety: Baseline: 8.84 ‐ wk 12: 7.04
Tønnesen 2013 For V vs placebo at 12 wks:
Craving: ‐0.26 for V (P < 0.0001)
Appetite: ‐0.14 for V (P = 0.001)
Total symptoms score: ‐0.16 (P = 0.002)
Hajek 2015 Smoking enjoyment ratings up to TQD:
Baseline/pre‐randomizarion: V: 2.5, placebo: 2.5
Day 15 (≤ 3 mg/day): V: 1.8, placebo: 2.1
Day 18 (≤ 4 mg/day): V: 1.7, placebo: 2.1
TQD (day 21; ≤ 5 mg/day): V: 1.6, placebo: 2.0