Background
Objectives
Methods
Search strategy
Inclusion criteria
Types of studies
Types of participants
Types of interventions
Types of outcome measure
Selection of included studies and data extraction
Data extraction
Assessment of risk of bias in included studies
Data synthesis
Unit of analysis issues
Results
Study characteristics
Study/design | Population | Interventions | Smoking abstinence outcomes | Secondary outcomes |
---|---|---|---|---|
Complex interventions | ||||
RCT | 298 clinically stable adult outpatients with ICD diagnosis of psychotic disorder who expressed an interest in quitting smoking and smoke ≥15 cigarettes per day. Australia 52% male, ethnicity not stated. | 1. Individual motivational interviewing/CBT 2. Usual care Intervention consisted of 8 × 1 hour sessions of manualised motivational interviewing and CBT over 10 weeks. | Continuous abstinence self report verified by expired CO < 10 ppm at 3,6, 12 months and 4 years 7 day point prevalence smoking abstinence verified by expired CO <10 ppm at 3, 6 12 months and 4 years | Change in psychiatric symptoms (BDI, BPRS, SF-12, STAI) |
Baker 2015 [32] RCT | 235 adult outpatients who expressed an interest in quitting smoking with ICD diagnosis of psychotic disorder and Smoking ≥15 cigarettes per day and with stable symptoms. Australia 59% male, 84% Australian born. | 1. Healthy lifestyle intervention (individual) 2. Telephone intervention Healthy lifestyle intervention consisted of manualised motivational interviewing and CBT delivered as a single 90 min sessions followed by 7 × 1 h sessions weekly then 3 fortnightly 1 h sessions then monthly 1 hour sessions for 6 months. The telephone intervention consisted of 1 face to face meeting followed by up to 16 × 10 minute manualised telephone sessions | 7 day point prevalence smoking abstinence verified by expired CO <10 ppm at 15 weeks and 12 months verified by expired CO measure Number of cigarettes per day FTND | Change in psychiatric symptoms (BBRS-24, BDI, SF-12 mental component) |
George 2000 [12] RCT | 45 participants with DSM IV schizophrenia or schizoaffective disorder with a FTND score of ≥5 United States 67% male, 62% white. | 1. ALA group programme + NRT patch 2. Specialised group programme + NRT patch *21 mg for 6 weeks then 14 mg for 2 weeks then 7md for 2 weeks ALA group consisted of 3 weekly 60 min manualised sessions of group counselling Specialised programme consisted of 3 weeks of 1 h motivational enhancement then 7 weeks 1 h of psychoeducation. All manualised | 7 day point prevalence abstinence at week 10, and 26 verified by expired CO <10 ppm. Continuous abstinence in last 4 weeks of treatment | Change in psychiatric symptoms (AIMS, BDI, PANSS, WEPS) |
Gilbody 2015 [33] RCT | 97 adult outpatients with DSM IV schizophrenia, schizoaffective disorder or bipolar disorder who expressed a desire to cut down or quit smoking and smoked ≥10 cigarettes per day. England 60% male, 87% white. | 1. Bespoke intervention 2. Usual care Intervention consisted of 8-10 × 30 min maunalised sessions tailored to the participants needs. | Smoking cessation at 12 months (CO ≤ 10 ppm) FTND Number of cigarettes per day | Change in psychiatric symptoms (SF-12, PHQ-9) |
Smith 2015 [34] RCT | 33 outpatients with DSM IV schizophrenia or schizoaffective disorder 73% male, 30% white. | 1. 5 sessions of transcranial direct current stimulation 2. 5 sessions of sham treatment | Self report number of cigarettes smoked and expired CO I week after final treatment session Urges to smoke | PANSS and PSYCHRATS hallucination scale |
Steinberg 2003 [15] RCT | 78 outpatients with DSM IV schizophrenia or schizoaffective disorder smoking ≥10 cigarettes per day United States 68% male, 77% white. | 1. Motivational interviewing (individual) 2. Psychoeducational intervention (individual) 3. Control Motivational interviewing consisted of 1 × 40 minute session. Psychoeducation consisted of 1 × 40 minute session Control consisted of 1 5 min session. | Expired CO at 1 week and 1 month Number of cigarettes per day Heaviness of smoking Contemplation ladder FTND Importance of quitting Confidence in ability to quit | |
Steinberg 2016 [36] RCT | 98 outpatients with DSM IV schizophrenia, schizoaffective disorder or Bipolar I 46% male, 61% white. | 1. Motivation interviewing 1 × 45 min personalised session 2. Interactive education 1 × 45 min non personalised session Motivational interviewing 1 45 min session manualised. Interactive education consisted of 1 × 45 min manualised session | Expired CO at 1 month Motivation to quit | |
Williams 2010 [23] RCT | 100 adult outpatients with DSM IV schizophrenia or schizoaffective disorder who Smoke ≥10 cigarettes per day and were willing to try and quit smoking. United States 64% male, 66% white. | 1. Treatment of nicotine addiction in schizophrenia + nicotine patch (individual) 2. Medication management + nicotine patch 3. (individual) *21 mg for 12 weeks and 14 mg for 4 weeks TANS consisted of 24 × 45 min sessions over 26 weeks of manualised motivational interviewing. MM consisted of 9 × 20 min sessions of manualised active education. | 7 day point prevalence abstinence at 3, 6 and 12 months verified by expired CO <10 ppm. Continuous abstinence at 3 months. | Change in psychiatric symptoms (BDI, PANSS) |
Wing 2012 [28] RCT | 15 DSM-IV schizophrenia or schizoaffective disorder, smoking ≥10 cigarettes per day for 3 years or more with expired CO ≥ 10 ppm and FTND score ≥ 4 and motivated to quit within the next month. Ethnicity and gender not reported. | 1. Trans cranial magnetic stimulation + weekly group therapy and nicotine patch (21 mg) 2. Sham + weekly group therapy and nicotine patch (21 mg) | Weekly (for 10 weeks) Smoking self report verified by expired CO. Tiffany questionnaire for smoking urges | Change in psychiatric symptoms (PANSS) Adverse events |
Bupropion studies | ||||
RCT | 19 DSM IV schizophrenia outpatients on a stable dose of antipsychotic medication for at least 4 weeks who smoke at least half a pack of cigarettes per day and express a wish to quit smoking United States 61% male, 89% white. | 1. Bupropion (150 mg per day) + CBT Quit Smoking Group 2. Placebo + CBT Quit Smoking group | 7 day point prevalence abstinence verified by expired CO < 9 ppm or serum cotinine <14 ng/ml at 12 and 24 weeks and 2 years Significant smoking reduction at12, 24 weeks and 2 years defined by ≥30% reduction in expired CO and ≥50% reduction in number of cigarettes per day | Change in psychiatric symptoms (BPRS, SANS, HamD, AIMS, Hillside Akathisia Scale, SAS) |
Evins 2005 [17] RCT | 19 DSM-IV schizophrenia or schizoaffective disorder outpatients and smokes 10 cigarettes per day with stable symptoms and on a stable dose of antipsychotic for >30 days HAM-D score ≤ 20 and willing to set a quit date within 4 weeks. United states 68% male, ethnicity not reported. | 1. Bupropion (150 mg) + behavioural therapy intervention 2. Placebo + behavioural therapy intervention | 7 day point prevalence abstinence at week and week 4, 12 and 24 verified by expired CO <9 ppm. 4 week continuous abstinence at week 24 Number of cigarettes smoked per day | Change in psychiatric symptoms (SANS, Ham-D, Ham-A, PANSSS, SAS, Barnes akathisia scale) Adverse events |
Evins 2007 [19] RCT | 51 adult outpatients DSM-IV Schizophrenia, capacity to consent, smokes 10 cigarettes per day with stable symptoms and on a stable dose of antipsychotic for 30 days and willing to set a quit date within 4 weeks United States 57% male, ethnicity not reported. | 1. Bupropion (150 mg 1 x daily 7 days then 150 mg 2× daily thereafter) + transdermal nicotine patch, nicotine polacrilex gum and CBT 2. Placebo + transdermal nicotine patch, nicotine polacrilex gum and CBT 21 mg/d 4 weeks, 21 mg/d 2 weeks then 7 mg/d 2 weeks 2 mg as needed up to 18 mg/d | 7 day point prevalence abstinence at week12, 24 and 52 verified by expired CO <8 ppm. 4 week continuous abstinence at week 8, 12, 24 and 52. | Change in psychiatric symptoms (SANS, Ham-D, STAI, PANSSS) |
Fatemi 2013 [30] RCT | 24 clinically stable DSM-IV schizophrenia or schizoaffective disorder, smoking ≥10 cigarettes per day expressing a motivation to quit or reduce smoking. United States Ethnicity and gender not reported. | 1. Bupropion + antismoking counselling 2. Varenicline + antismoking counselling 3. Placebo + antismoking counselling | Self report abstinence verified by CO Serum and urine levels of nicotine and cotinine | Change in psychiatric symptoms (BPRS, SAPS, SANS, BDI, CSSRS, WISDM, MNWS) Adverse events |
George 2002 [14] RCT | 32 clinically stable adult outpatients on a stable dose of medication with DSM IV schizophrenia or schizoaffective disorder smoking ≥10 cigarettes per day with expired CO > 10 ppm, plasma cotinine >150 ng/ml and scored ≥5 on FTND and ≥3 on an assessment measure of self-reported motivation indicating a strong desire to quit smoking. US 56% male, 63% white. | 1. Bupropion (150 mg 2× day) + specialised schizophrenia smoking cessation program 2.Placebo +specialised schizophrenia smoking cessation program | 7 day point prevalence abstinence at week 10, and 36 verified by expired CO <10 ppm. Tiffany questionnaire for smoking urges | Change in psychiatric symptoms (AIMS, BDI, PANSS, WEPS) |
George 2008 [21] RCT | 58 clinically stable outpatients with DSM IV schizophrenia or schizoaffective disorder on a stable dose of antipsychotic medication and smoking ≥10 cigarettes per day with expired CO > 10 ppm and scored ≥7 on the contemplation ladder United States 60% male, 48% white. | 1. Bupropion + manualised group behavioural therapy + NRT patch (21 mg) 2. Placebo + manualised group behavioural therapy NRT patch (21 mg) 150 mg per day days 1–3 and 150 mg 2 x day thereafter | 7 day point prevalence abstinence at week 10, and 26 verified by expired CO <10 ppm. 4 week continuous abstinence at week 10. | Change in psychiatric symptoms (BDI, PANS) Adverse events |
Weinberger 2008 [22] RCT | 5 clinically stable DSM-IV Bipolar disorder I outpatients smoking ≥10 cigarettes per day with expired CO ≥ 10 ppm United States 40% male, 100% white. | 1. Bupropion + manualised group behavioural therapy 2. Placebo + manualised group behavioural therapy (Days 1–3 75 mg 1 x day, days 4–7 150 mg 1 x day and 150 mg 2× day thereafter) | Abstinence at 10 weeks verified by expired CO <10 ppm. | Change in psychiatric symptoms (YMRS, BDI, Ham-D) Adverse events |
Weiner 2012 [25] RCT | 41 clinically stable adult outpatients with DSM IV schizophrenia or schizoaffective disorder who Smoke ≥10 and scored ≥ x on FTND United States 79% male. 72% white. | 1. Bupropion + group support programme 2. Placebo + group support programme (Days 1–3150 mg 1 x day and 150 mg 2× day thereafter) | Complete abstinence at 15 weeks defined by expired CO < 10 ppm at last 4 study visits. Complete abstinence at 6 months and 12 months self-report verified by CO < 10 ppm 7 day point prevalence abstinence at 15 weeks verified by CO < 10 ppm FTND | Change in psychiatric symptoms (BPRS, SANS, SAS) Adverse events |
Tidey 2011 [24] RCT | 57 clinically stable adult outpatients with DSM IV schizophrenia or schizoaffective disorder on a stable dose of psychoactive medication who Smoke ≥20 cigarettes per day and scored ≥6 on FTND and ≥4 on the contemplation ladder indicating some interest in quitting smoking United states 71% male, 75% white. | 1. Contingent + Bupropion (150 mg per day days 1–3 and 150 mg 2 x day thereafter) 2. Contingent + placebo 3. Bupropion (150 mg per day days 1–3 and 150 mg 2 x day thereafter) + non-contingent 4. Placebo +non contingent Non contingent = $25 dollar store card Contingent = $25 store card plus bonuses | Cotinine in urine CO breath measure Number of cigarettes per day At weeks 1,2,3 and 4 | Change in psychiatric symptoms (PANSS, UPDRS, AIMS) |
Varenicline studies | ||||
Chengappa 2014 [31] RCT | 60 adult outpatients with DSM-IV bipolar disorder on a stable dose of medication. Smoking ≥10 cigarettes per day with expired CO ≥ 10 ppm United States Ethnicity and gender not reported. | 1. Varenicline + smoking cessation counselling 2. Placebo + smoking cessation counselling1 × 0.5 mg per day days 1–3, 0.5 mg 2× per day days 4–7 then 1 mg 2× per day thereafter | 7 day point prevalence smoking abstinence verified by expired CO <10 ppm at 12 weeks and 24 weeks Continuous 4 week abstinence at 12 weeks | Change in Psychiatric symptoms (YMRS, MADRS, HARS, CGI) Adverse events |
Smith 2016 [35] RCT | 87 adult inpatients or outpatients with DSM IV schizophrenia or schizoaffective disorder who smoke at least 6 cigarettes per day or in the case of inpatients had flouted the smoking ban on several occasions. United States, Israel and China 85% male, 31% white. | 1. Varenicline + smoking prevention counselling 2. Placebo + smoking prevention counselling 1 × 0.5 mg per day days 1–3, 0.5 mg 2× per day days 4–7 then 1 mg 2× per day thereafter | Self-reported number of cigarettes smoked per day Expired CO, cotinine levels and urges to smoke. | Change in psychiatric symptoms (PANSS, SANS, Calgary Depression Scale) Adverse events |
Weiner 2011 [25] RCT | 9 Clinically stable adult outpatients with DSM IV schizophrenia or schizoaffective disorder for 3 years who smoke ≥10 and scored ≥4 on FTND. United States Ethnicity and gender not reported. | 1. Varenicline (1 mg 2× day) + individual smoking cessation counselling (ALA) 2. Placebo + individual smoking cessation counselling (ALA) | Smoking cessation at 12 weeks defined by expired CO < 10 at last 4 study visits. Change in CO | Change in psychiatric symptoms (BPRS) Adverse events |
Williams 2012 [27] RCT | 128 adult outpatients with DSM IV schizophrenia or schizoaffective disorder with stable symptoms who Smoke ≥15 and scored ≥7 on the contemplation ladder indicating a willing ness to quit in the next month and with no smoking abstinence in the last 3 months United States and Canada 76% male, 59% white. | 1. Varenicline 2. Placebo 1 × 0.5 mg per day days 1–3, 0.5 mg 2× per day days 4–7 then 1 mg 2× per day thereafter | 7 day point prevalence abstinence at 12 and 24 weeks verified by expired CO <10 ppm. Number of cigarettes per day | Change in psychiatric symptoms (SAS, C-SSRS, CGI, PANSS) Adverse events |
Wu 2012 [37] RCT | 5 psychiatrically stable DSM-IV bipolar disorder I or II on a stable dose of mood stabliser, smoking ≥10 cigarettes per day. Outpatients 40% male, 100% white | 1. Varenicline (1 mg 2× day) + smoking cessation counselling (group) 2. Placebo + smoking cessation counselling (group) | Smoking cessation verified by expired CO >10 ppm at 10 weeks and 6 months | Adverse events |
Nicotine Replacement Therapy (NRT) studies | ||||
Chen 2013 [29] RCT | 184 adult inpatients who were regular daily smokers with DSM-IV schizophrenia or schizoaffective disorder with stable symptoms. Taiwan93% male, ethnicity not stated. | 1. High dose NRT (31.2 mg for 4 weeks then 20.8 mg for 4 weeks) 2. Low dose NRT (20.8 mg for 8 weeks) | 7 day point prevalence self report verified by expired CO <10 ppm at 5 weeks and 8 weeks Number of cigarettes smoked per day FTND | Change in psychiatric symptoms (PANSSS, SAS) |
Dalak 1999 [11] RCT (within subject crossover) | 19 male veteran outpatients with DSM III schizophrenia, schizoaffective disorder Smoking ≥20 cigarettes per day on a stable antipsychotic regime. United States 100% male, 60% white. | 1. Nicotine patches (22 mg per day) 2. Placebo patches | Nicotine blood level Expired CO Cotinine blood level | Change in psychiatric symptoms (BPRS, SANS, HAM-D) Adverse events |
Gallagher 2007 [20] RCT | 181 stable adult outpatients with DSM-IV schizophrenia or schizoaffective disorder, smoking ≥10 cigarettes per day for 3 years or more with expired CO ≥ 10 ppm after 15 min smoke free. United States 52% male, 76% white. | 1. Contingent reinforcement (up to $480) 2. Contingent reinforcement (up to $480) + NRT patch (21 mg) 3. Self-quit group | Smoking cessation at week 20 and week 36 (Cotinine ≤15 ng/ml or expired CO ≤ 10 ppm) FTND | Change in psychiatric symptoms (BSI) |
Description of the interventions
Methodological quality
Adequate sequence generation | Allocation concealment | Blinding of participants and personnel | Blinding of outcome assessment | Incomplete outcome data addressed | Free of selective reporting | Free of other bias | Overall | |
---|---|---|---|---|---|---|---|---|
Baker 2006 [18] | Unclear | High Risk | High Risk | Low Risk | Low Risk | Low Risk | Low risk | High risk |
Baker 2015 [32] | Unclear | Unclear | High Risk | Low Risk | High Risk | Low Risk | Low risk | High |
Chen 2013 [29] | Unclear | Unclear | Unclear | Unclear | Low Risk | Unclear | Low risk | Unclear |
Chengappa 2014 [31] | Unclear | Unclear | Low Risk | Low Risk | Unclear | Low risk | Low risk | Unclear |
Dalak 1999 [11] | Unclear | Unclear | Unclear | Unclear | Unclear | High risk | High risk | Unclear |
Evins 2001 [13] | Unclear | Unclear | Unclear | Unclear | Low Risk | Unclear | Low risk | Unclear |
Evins 2005 [17] | Unclear | Unclear | Unclear | Unclear | Unclear | Unclear | High risk | Unclear |
Evins 2007 [19] | Unclear | Unclear | Unclear | Unclear | Unclear | Unclear | Low risk | Unclear |
Fatemi 2013 [30] | Unclear | Unclear | Unclear | Unclear | Unclear | Unclear | Unclear | Unclear |
Gallagher 2007 [20] | Unclear | Unclear | High Risk | High Risk | High risk | Unclear | Low risk | High |
George 2000 [12] | Unclear | Unclear | High Risk | Unclear | Unclear | Unclear | High risk | High |
George 2002 [14] | Unclear | Unclear | Low Risk | Low Risk | Low risk | Unclear | Low risk | Unclear |
George 2008 [21] | Unclear | Unclear | Unclear | Unclear | High risk | High risk | Low risk | High |
Gilbody 2015 [33] | Low Risk | Low Risk | High Risk | High Risk | Low Risk | High Risk | Low risk | High |
Steinberg 2003 [15] | Unclear | Unclear | High Risk | Low Risk | High Risk | Unclear | Low risk | High |
Tidey 2011 [24] | High Risk | High Risk | Low Risk | Low Risk | High Risk | Unclear | High risk | High |
Weinberger 2008 [22] | Unclear | Unclear | Unclear | Unclear | High Risk | Unclear | High risk | High |
Weiner 2011 [25] | Unclear | Unclear | Unclear | Unclear | Unclear | Unclear | Unclear | Unclear |
Weiner 2012 [26] | Unclear | Unclear | Unclear | Unclear | Low risk | Unclear | Low risk | Unclear |
Williams 2010 [23] | Unclear | Unclear | High Risk | Low Risk | High Risk | Unclear | High risk | High |
Williams 2012 [27] | Unclear | Unclear | Low Risk | Low Risk | Low Risk | Low Risk | Unclear | Unclear |
Wing 2012 [28] | Unclear | Unclear | Unclear | Unclear | Unclear | Unclear | Unclear | Unclear |
Wu 2012 [37] | Unclear | Unclear | Unclear | Unclear | Unclear | Unclear | Unclear | |
Steinberg 2016 [36] | Unclear | Unclear | High risk | Low risk | Low risk | Unclear | High risk | High |
Smith 2015 [34] | Low risk | Low risk | Low risk | Low risk | Unclear | Unclear | Low risk | Low risk |
Smith 2016 [35] | Low risk | Low risk | Low risk | Low risk | Low risk | Low risk | Unclear | Low risk |
Smoking abstinence
Bupropion versus placebo
Varenicline versus placebo
Specialist smoking cessation programme
Secondary outcomes
Change in psychiatric symptoms
Change in BMI | Change in psychiatric symptoms | Adverse events | Quit rate (%) intervention (I) control (C) | |
---|---|---|---|---|
Complex interventions | ||||
Not reported | Time-points: 4 months, 7 months, 13 months CDI: significantly lower score for intervention group p < 0.001 at all time-points BPRS: not significant at any time point SF-12 (mental): significantly lower score for intervention group p < 0.001 at all time-points STAI: significantly lower for intervention group p < 0.001 at 7 months | Not reported | 4 months I: 22/147 (15.0) C: 9/151 (6.0) 7 months I: 14/147 (9.5) C: 6/151 (4.0) 13 months I: 16/147 (10.9) C: 10/151 (6.6) 4 years I: 13/147 (8.8) C: 17/151 (11.3) | |
Baker 2015 [32] | Not reported | Time point 3.75, 12 months BPRS, BDI, GAF, SF-12 not significant | Not reported | 3 months I: 13/122(10.7) C: 13/113 (11.5) 12 months I: 8/122 (6.6) C: 7/113 (6.2) |
George 2000 [12] | Not reported | Time-points: 3 months, 8.5 months AIMS, BDI, PANSS, WEPS: not significant | Not reported | 3 months I: 10/28 (35.7) C: 6/17 (35.3) 8.5 months I: 3/28 (10.7) C: 3/17 (17.6) |
Gilbody 2015 [33] | Change in BMI not reported. Mean BMI at baseline and 12 month reported. | Time points 1,6,12 months PHQ-9, EQ-5D, SF-12 mental reported but not tested for significance | 21 events of which 12 SAEs, 10 in intervention 2 in usual care | 12 months I: 12/33 (36.3) C: 8/35 (22.9) |
Smith 2015 [34] | Not reported | Time point after final session PANSS and PYCHRATS no significant differences | 15 AEs in active treatment arm and 16 in sham treatment arm | Abstinence not reported |
Steinberg 2003 [15] | Not reported | Not reported | Not reported | Abstinence not reported |
Steinberg 2016 [36] | Not reported | Not reported | Not reported | 1 month I: 8/49 (16.3) C: 5/49 (10.2) |
Williams 2010 [23] | Not reported | Time-point 3 months BDI and PANSS positive and negative not significant | Not reported | 3 months I: 7/45 (15.6) C: 11/42 (26.2) 6 months I: 7/45 (15.6) C: 8/43 (18.6) 12 months I: 6/45 (13.3) C: 6/43 (14.0) |
Wing 2012 [28] | Not reported | No detail on secondary outcomes given | Not reported | Abstinence not reported |
Bupropion studies | ||||
Time-points 3 months, 6 months AIMS, SANS, SAS: not significant BPRS (total): significant decrease intervention group 0–3 months (p = 0.03) and 3–6 months (p = 0.02) BPRS (+ve symptoms): significant decrease intervention group 0–3 months (p = 0.03). Not significant 3-6 m. HAM-D: significant increase for placebo group 0–3 months (p < 0.01). Not significant 3-6 m. HAS: not significant | No adverse events | 1 months I: 3/9 (33.3) C: 1/9 (11.1) 3 months I: 1/9 (11.1) C: (0/9) (0.0) 6 months I: 1/9 (11.1) C: 0/9 (0.0) 24 months I: 2/9 (22.2) C: 2/9 (22.2) | ||
Evins 2005 [17] | Not reported | Time-points 3 months Barnes Akathisia Scale: not significant HAM-A, HAM-D, SANS, SAS, WEPS, PANSS (total): not significant PANSS (subscale); significant increase in excitement score placebo versus intervention group (P = 0.017) Significant decrease cognitive score intervention versus placebo (P = 0.029) Other subscales not significant | 3 events requiring withdrawal, 1 in the intervention, 2 group unknown | 1 months I: 9/25 (36.0) C: 2/28 (7.0) 3 months 4/25 (16.0) c: 2/28 (0.0) 3.5 months I: 2/25 (8.0) C: 1/28 (3.6) 6 months I: 1/25 (4.0) C: 1/28 (3.6) |
Evins 2007 [19] | Not reported | Time-points: 3 months AIMS, BDI, SANS, STAI, HAM-D, PANSS: not significant Barnes Akathisia Scale: significantly lower in intervention group (P = 0.005) SAS: significantly lower score in the intervention group (P = 0.016) | No SAEs | 2 months* I: 13/25 (52.0) C:5/26 (19.2) 3 months* I: 9/25 (36.0) C: 5/26 (19.2) 6 months* I: 5/25 (20.0) C: 2/26 (7.7) 15 months* I: 3/25 (12.0) C: 2/26 (7.7) |
Fatemi 2013 [30] | Not reported | Time point: 3 months Significant positive correlation between serum cotinine levels and BPRS total score (p = 0.014), BPRS +ve subscale score (p = 0.002), SAPS total composite score (p = 0.02) and SAPS delusion subscale score (p = 0.013) | Not fully reported | Abstinence not reported |
George 2002 [14] | Not reported | Time-points 2.5 months, 8.5 months AIMS, BDI, WEPS: not significant PANSS: significant decrease in intervention group for negative symptoms (P < 0.05; general positive subscales not significant | Not reported | 2.5 months I: 8/16 (50.0) C: 2/16 (12.5) 8.5 months I: 3/16 (18.8) C: 1/16 (6.3) |
George 2008 [21] | Not reported | Time-points: 2.5 months, 6.75 months BDI, PANSS: not significant | No SAEs | 2.5 months I: 10/29 (34.5) C: 3/29 (10.3) 6.75 months I: 4/29 (13.8) C: 0/29 (0.0) |
Weinberger 2008 [22] | Not reported | No details given on secondary outcomes | Not fully reported | 2.5 months I: 1 /2 (50.0) C: 0/3 (0.0) |
Weiner 2012 [26] | Not reported | Time-points: 2 weeks, 1 month, 2 months and 3.5 months BPRS, SANS: not significant | 5 SAEs in the intervention group and 2 in the placebo group | 3.5 months I: 8/24 (33.3) C: 3/22 (13.6) |
Tidey 2011 [24] | Not reported | Time-points 1,2, 3, 4 weeks PANSS, UPDRC ad AIMS not significant | Not fully reported incidence of specific AEs reported but not all | Abstinence not reported |
Varenicline studies | ||||
Chengappa 2014 [31] | Mean weight gain | Time-points 3, 6 months Scores for MADRS, YMRS, HARS and CGI reported but not tested for significance. | 6 SAEs in the intervention group and 4 in the placebo group | 3 months I: 15/31 (48.4) C: 3/29 (10.3) 6 months I: 6/31(19.4) C: 2/29 (6.9) |
Smith 2016 [35] | Not reported | Time-point 8 weeks Scores for PANSS, and SANS not significant when corrected for multiple comparisons. | Comparisons made between number of AEs in both groups. Concluded that no AE involving emergent psychiatric symptoms could be attributed to varenicline. | 8 weeks I:7/42 (16.7) C: 4/45 (8.9) |
Weiner 2011 [25] | Not reported | Time-points 3 months BPRS +ve items, anxiety/depression not significant | 8 side effects in the intervention group 2 in the placebo group | 4 months I: 3 /4 (0.75) C: 0/4 (0.0) |
Williams 2012 [27] | Not reported | Time-points: 3, 6 months PANSS not significant | 9 SAEs in the intervention group and 4 in the placebo group | 3 months I: 16/84 (19.0) C: 2/43 (4.7) 6 months I: 10/84 (11.9) C: 1/43 (2.3) |
Wu 2012 [37] | Not reported | Time-points 2.5 months Psychiatric symptoms not significantly changed | Not fully reported | 2.5 months I: 1/3 (33.3) C: 0/2 (0.0) 6 months I: 0/3 (0.0) C: 0/2 (0.0) |
NRT studies | ||||
Chen 2013 [29] | Not reported | Time-points: 2 months PANSS, SAS not significant | Not reported | 2 months I: 1/92 (1.1) C: 4/92 (4.3) I = high dose C = low dose |
Dalak 1999 [11] | Not reported | Time-points: day 2 AIMS: significantly increased score intervention group day 2 (p < 0.05) BPRS, HAM-D, SANS, SAS: not significant | Assessment for signs of nicotine toxicity none reported | Abstinence not reported |
Gallagher 2007 [20] | Not reported | Time points 5, 9 months BSI not significant | Not reported | 5 months Ia**: 23/60 (38.3) Ib***: 25/60 (41.7) C: 3/60 (5.0) 8.5 months Ia: 22/60 (36.7) Ib: 26/60 (43.3) C: 5/60 (8.3) |