Smokers with MI or SMI Reduced Quitting over Lifetime

Mental Illness (MI) = anxiety, MDE, PTSD, psychoses, bipolar, drug dependenceSerious Mental Illness (SMI)= measured by K6

Hagman 2007; McClave 2010; Lasser 2000; Pratt & Brody 2010

Form

er S

mok

ers (

%) E= N x S

Exsmokers =(number trying to quit) x (success of attempts)

R West, 2013

Smokers with Depression Less Likely to Quit

fewer former smokers

Smoking Cessation in Outpatient SA treatment

• Part of CTN, included methadone sites• N=225 smokers 

SC adjunct or  treatment‐as‐usual (TAU) 9 weeks group counseling plus NP

• No difference in SC vs TAU–on rates of retention in SA tx–abstinence from primary substance–craving for primary substance.

Reid et al., 2008

Heaviness of Smoking Index=

Measure of Dependence

Number of cigarettes per day (cpd)

AM Time to first cigarette (TTFC)≤ 30 minutes = moderate ≤ 5 minutes = severe 

Heatherton 1991

Smokers with Depression Smoke More CPD & Are

More Dependent

Greater Nicotine Dependence in Serious Psychological Distress

0

10

20

30

40

50

60

70

NDSS TTFC 5 Mins TTFC 30 Mins

SPD

noSPD

%

2002 National Survey on Drug Use and Health; Hagman et al., 2008

SPD= Estimate of Serious Mental Illness

Smokers in Addiction Treatment Moderately to Severely Addicted

to Nicotine

N=1882 smokers in NJ addictions treatment, 2001-2002; Williams et al., 2005

Williams et al., NTR 2010

Individuals with Schizophrenia Highly Addicted

4 minute Nicotine Boost (ng/mL)

25.2 vs. 11.1 ; p<0.01

Greater nicotine intake per cigarette

Tobacco WithdrawalEmerge hours after last cigarette

Can last for (4) weeks

Depressed moodInsomniaIrritability, frustration or angerAnxietyDifficulty concentratingRestlessnessIncreased appetite or weight gain

DSM-5

Reduced Success Quitting in Smokers with Anxiety

Disorders

panic, social anxiety or GAD

More withdrawal symptoms

Piper et al., 2010

NRT and Agitationin Smokers w/Schizophrenia:

• 40 smokers in psych ER• 21mg patch vs placebo patch• Usual care for psychosis• Agitated Behavior was 33% less at 4 hours and 23% lower at 24 hours for NRT group

• Better response in lower dependence• Same magnitude of response as antipsychotic studies Allen 2011; Am J Psych

READINESS to QUIT in SPECIAL POPULATIONS

* No relationship between psychiatric symptom severity and readiness to quit

Smokers with mental illness or addictive disorders are just as ready to quit smoking as the general population of smokers.

Slide Courtesy J Prochaska; Acton 2001; Prochaska 2004; Prochaska 2006; Nahvi 2006

Barriers to Addressing Tobacco in Mental Health

• Undervalue of tobacco use as an addiction• Consumers/ families minimize the health risks of tobacco 

• Professionals/ MH systems have been slow to change  in addressing tobacco

• Lack the knowledge about effectiveness of treatment

• Lack of advocating for treatment• Lack of adequate reimbursement

Williams & Ziedonis, Addictive Behaviors, 2004

Clinicians Belief that patients were not interested in quitting was a major barrier to giving smoking cessation treatment

Almost HALF (42% of patients) answered “yes” to question Do you have an interest in quitting on their psychiatric assessmentfrom charts (49/117) reviewed same study

77% 83%

020406080100120

Himelhoch Williams

Williams et al., in press; Himelhoch et al., 2014

Which Approach to TakeImplement current

evidence based practices?

Public health modelPrimary care Brief strategies Limited insurance

coverageTelephone

counseling

Develop tailored approaches?

Clinical/ co-occurring treatment model

Behavioral healthFace to face Longer treatmentExpanded Medicaid and

Medicare coverage for treatment

Behavioral Health Professionals are Experts in Psychosocial Treatments

• Counseling = First‐line treatment

• Effective treatments: Individual or group; CBT, relapse prevention, social skills

• Intensive Treatments– Sessions > 10 minutes– More than 4 sessions– Tobacco treatment specialists– Behavioral health and/or addictions specialists

Need for Pharmacotherapy in Tobacco Users w/MI and SUD

No reason not to useNRT is not a “new drug”First line treatment/ Recommended all Comfortable detox for temporary abstinenceHigher levels of nicotine dependencePsychiatric inpatients not given NRT were > 2X likely to be discharged from the hospital AMA

Fiore 2008; Prochaska 2004

Old NRT Guidelines

With caution (talk to doctor) if:Recent MISmokes < 10 cpdPregnant/breastfeeding Adolescents (Not FDA approved)

Mild side effectsMostly localSystemic, less common

NRT Labeling Updates

• No significant safety concerns associated with using more than one NRT 

• No significant safety concerns associated with using NRT at the same time as a cigarette. 

• Use longer than 12 weeks is safeAPRIL2013 www.fda.gov/ForConsumers/ConsumerUpdates/ucm345087.htm

Varenicline and Suicide 80,660 smokers prescribed  NRT (~63k), varenicline (~11k), and 

bupropion (~6k);    UK, primary care

Compared with NRT, the hazard ratio for self harm among people prescribed varenicline was 1.12 (95% CI 0.67 to 1.88), and it was 1.17 (0.59 to 2.32) for people prescribed bupropion.

No clear evidence that varenicline was associated with an increased risk of fatal (n=2) or non‐fatal (n=166) self harm

No evidence that varenicline was associated with an increased risk of depression or suicidal thoughts

Gunnell et al., 2009; BMJ

Review of Studies forNeuropsychiatric Adverse Events

• 17 Pfizer‐sponsored studies (N=8027)– 1004 with psychiatric

• DOD (N=35,800) VAR vs NRT– No ↑ in hospitaliza ons for AE– Prior to FDA warning;  gen pop sample

• Depression, aggression/agitation, suicidal events and nausea

Gibbons et al., AJP, 2013

• VAR not significantly associated with suicidal thoughts or behavior (OR=0.57)

• VAR not significantly associated with depression (OR=1.01)

• VAR not significantly associated with aggression/ agitation (OR=1.27)

• Rates of NPAE   2.28% VAR vs  3.16% for NP

Varenicline‐Major Depression

• 525 past h/o or stable, treated MDE; >10 cpd

• MADRS, HAM, C‐SSRS, SBQ• 73% on antidepressants (SSRI or SNRI)

• VAR More effective vs placebo• Week 12 CAR: 35.9% vs 15.6%  for placebo  (OR 3.35; p<0.001)

• 24 and 52 week outcomes also significantAnthenelli et al., Ann Int Med, 2013

No Worsening of Depression ScoresNo difference in AEs (abnormal dreams, anxiety, agitation, restlessness, SI)

Anthenelli et al., Ann Int Med, 2013

Safety and Efficacy of Varenicline for Smoking Cessation Schizophrenia/ 

Schizoaffective Disorder

P=0.09

OR: 6.18 95% CI: 0.75, 50.71

P=0.046

OR: 4.74 95% CI: 1.03, 21.78

Parti

cipa

nts

(%)

10/83(11.9%)

2/43 (4.7%)

16/83 (19.0%)

1/43(2.3%)

Williams et al., J Clin Psychiatry 2012

At Weeks 12 and 24

Abs

tinen

t sub

ject

s (%

)

Week24

By weekVareniclinePlacebo

VareniclinePlacebo

No Worsening SchizophreniaPANSS by Week Mean Score

Mean baseline total scoreVarenicline: 55.8Placebo: 54.4

Total score

Week

No significant changes in PANSS from baseline in any treatment arm in total score

or sub-scores

Positive symptom score Negative symptom score

Anxiety item Depression item

Varenicline Placebo

Williams et al., J Clin Psychiatry 2012

Maintenance Varenicline Greater abstinence at 1 year

87 smokers with SCZ/ BPD from open label phase

Randomized at week 12 to 1mg BID

Evins, JAMA 2014; Pachas et al., JDD 2012

No treatment effect on psychiatric symptoms, health, BMI Evins, JAMA 2014; Pachas et al., JDD 2012

Improved Mental Health with Quitting Smoking

• Meta‐analysis 26 studies (14 gen pop, 4 psychiatric, 3 physical conditions, 2 psychiatric or physical, 2 pregnant, 1 post‐op) 

Taylor et al, BMJ, 2014

Reduced Access to Tobacco Treatment in Behavioral

Health Settings• Nicotine dependence documented in 2% of

mental health records• Only 1.5% of patients seeing an outpt

psychiatrist received treatment for smoking

Peterson 2003; Montoya 2005; Himelhoch 2014

Less than half (44%) of clinicians in community mental health sites ask their patients about smoking

State Hospital Smoking Survey2011; 206 Hospitals Surveyed; 80% response rate

Almost 80% no‐smoking on premisesLess than 35% treatment

Schacht et al., NASMHPD Research Institute, Inc. 2012

020406080100

2006 2007 2011

% TobaccoFree StateHospitals

Treatment

35%

Less than Half of US Substance Abuse Facilities Treat this Substance

National survey of  550 OSAT units (2004–2005)– 88% response rate

41% offer smoking cessation counselingor pharmacotherapy

38% offer individual/group counseling17% provide quit‐smoking medication 

Friedmann et al., JSAT 2008

41%

This probably isn't the best way to quit smoking

Conclusions

Reduced lifetime quitting Higher levels of nicotine dependence and psychosocial factors 

Need for combination (medications + counseling) approaches

Treatments safe and do not worsen illnessReduce barriers to treatment in behavioral health setting