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Table 1 Study characteristics

From: Smoking cessation in severe mental ill health: what works? an updated systematic review and meta-analysis

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 (31.2 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)
  1. AIMS abnormal involuntary movement scale; ALA American Lung Association; BDI Beck Depression Index; BPRS Brief Psychiatric Rating Scale; CBT cognitive behaviour therapy; CGI-S Clinical Global Impression- Severity of Illness Scale; CO carbon monoxide; C-SSRS Columbia Suicide Severity of Illness Scale; DSM Diagnosis and Statistical Manual; Ham-D Hamilton Depression Rating Scale; FTND Fagerstrom Test fro Nicotine Dependence; ICD International Classification of Disease; MADRS Montgomery-Asberg Depression Scale; MNWS Minnesota Withdrawal Scale-Revised; NRT nicotine replacement therapy; PANSS: Positive and Negative Syndrome Scale; SANS Scale for Assessment of Negative Symptoms; SAS Simpson Angus Scale; SF-12 21 item Short Form Survey on general functioning; SRP Sustained Release Preparation; p.p.m. parts per million; STAI State Trait Anxiety Inventory; UPDRS Unified Parkinson’s Disease Rating Scale; WEPS Webster Extrapyramidial Movement Scale; WISDM Wisconsin Inventory of Smoking Dependence Motives; YMRS Young Mania Rating Scale