Study/design | Population | Interventions | Smoking abstinence outcomes | Secondary outcomes |
---|---|---|---|---|
Complex interventions | ||||
Baker 2006 [18, 38] (including data from Baker 2010) 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 | ||||
Evins 2001 [13, 16] (including data from Evins 2004) 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 (31.2Â mg for 4Â weeks then 20.8Â mg for 4Â weeks) 2. Low dose NRT (20.8Â mg for 8Â weeks) | 7Â day point prevalence self report verified by expired CO <10Â ppm at 5Â weeks and 8Â 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) |