1. Evidence-based medication treatment of tobacco use disorder in people with mental health and addictions

2. The prescriber role: The 5 As
Ask about tobacco use. Identify and document tobacco use status for every patient at every visit.
Advise to quit. In a clear, strong and personalized manner urge every tobacco user to quit.
Assess willingness to make a quit attempt. Is the tobacco user willing to make a quit attempt at this time?
Assist in quit attempt. For the patient willing to make a quit attempt, offer medication and provide or refer for counseling or additional treatment to help the patient quit. For patients unwilling to quit at the time, provide interventions designed to increase future quit attempts.
Arrange follow-up. For the patient willing to make a quit attempt, arrange for follow-up contacts, beginning within the first week after the quit date. For patients unwilling to make a quit attempt at the time, address tobacco dependence and willingness to quit at next clinic visit. 2
Dixon et al 2009

3. First line cessation meds
Bupropion, nicotine replacement, varenicline
Using medication doubles or triples chance of quitting
All have been shown effective in people with behavioral health conditions
Cessation medications reduce craving while quitting – studies show impact for use up to a year
Nicotine replacement and varenicline reduce nicotine withdrawal symptoms (look at withdrawal slides or video)
Much more effective if used in combination
NRT most effective in combination: daily patch plus prn gum
NRT with other medications may be more effective then either alone
Individual counseling or group/class teach quit skills
Counseling + combination pharmacotherapy = quit success

4. Assess tobacco use
Assessment enables tailored prescribing and effective coaching on how to use medication treatments
Type of tobacco used
Amount tobacco used
When tobacco used
Triggers and high risk situations
Previous quit attempts – what worked, what didn’t work, how meds and other treatments helps/hurt

5. Assess mental health and substance use disorders
Ensure patient is engaged in treatment
Tobacco cessation treatment can be integrated with mental health and addiction treatment at same time
Best if outpatients are stable
Inpatients benefit from full dose treatment to reduce withdrawal, because withdrawal symptoms can be confused with mental illness symptoms or withdrawal from other substances

6. Nicotine Replacement Therapy (NRT)
Available in: patch, gum, lozenge, spray
Patch Dosing: Apply patch to alternating arm every day:
21 mg/D X 6 wks, then 14 mg/D X 2 wks, 7 mg/d X 2 wks (total 10 weeks, OK to use up to 1 year)
Adjust dose based on how much people smoke: If smokes ≤1/2 pack/day then start with 14 mg/d patch plus prn gum or lozenge
Lozenge/gum dosing: 2 mg or 4 mg prn craving hourly 8Xday if used with patch, up to 24Xday without patch – adjust based on level of smoking
Combination daily NRT patch with prn NRT gum/lozenge is most effective
Start on quit date – OK to start a month earlier
Using prn gum or lozenge to cut down by skipping cigarettes increases self efficacy and can lead to cessation

7. USE NRT gum in advance of high risk situations
Nicotine blood levels
NRT gum blood levels are lower and increase slower than cigarette = less addictive but requires planning. Use 15 minutes before high risk situations

8. instructions for using nrt
Gum: Chew until taste flavor, then ‘park’ between teeth/gum and lining of cheek. Repeat, parking at different spot, for up to 30 minutes
Lozenge: Good for those with dentures. Suck until taste flavor, then ‘park’ between teeth/gum and lining of check. Repeat, parking at different spot, for up to 30 m.
The nicotine will be absorbed through oral mucosa, NOT swallowed. Nicotine takes 15 min to achieve peak
Avoid coffee/orange just before use; reduces absorption
People need to anticipate situations with urges; use in advance
If people develop nausea - they are swallowing the nicotine rather than allowing mucosal absorption
If people develop mucosal irritation - they are not moving the gum/lozenge around enough or need lower dose

9. instructions for using nrt
Patch: Apply 1 to upper arm 1st thing in the morning
Leave on for 24 hours, then remove and place new patch on adjacent area or other arm to avoid irritating skin.
If patient usually smokes within 30 minutes upon awakening, use gum or lozenge immediately as well as placing patch upon awakening
Use prn gum or lozenge to deal with cue-induced craving
Patch gives steady level of nicotine that suppresses withdrawal, but does not reduce cue-induced craving.
Is person a night smoker? If so, keep patch on at night and use nighttime NRT. If not, may need to remove patch to avoid dreams

10. NRT Safety and side effects Can people use NRT while smoking?
Yes, higher doses and smoking on patch is safe (Benowitz 1998; Zevin 1998)
Use in patients with cardiac and surgical disease is safe after stabilization (Silva 2016; Nolan 2015)
Nicotine slightly increases blood pressure and heart rate in lab but not in clinical use
Nicotine does not interact with behavioral health medications
Nicotine side effects
Headache, stomach upset, diarrhea, dizzy, insomnia, dream, local irritation at site of use
If side effects occur,
Remove NRT or stop smoking.
Adjust strategy (move location, reduce dose, change timing)

11. What to do if person says they tried it before and it didn’t work
Find out how it was used before: most people do not use high enough dose and/or use incorrectly
Address efficacy - adjust dose based on amount smoking – usually need higher dose or combination patch +gum or lozenge
Show them how to use it correctly – See Brunette video or other Youtube video demonstrations
Address side effects by teaching correct use and adjusting timing of use

12. Bupropion (Zyban) NE and DA reuptake inhibitor
Also commonly used as antidepressant
Dose: 300 mg/day (150 BID) – up to a year
Interactions: Inhibits hepatic enzyme 2D6, metabolized by 2B6, reduces seizure threshold
Consider reduce dose of these concomitant meds
aripiprazole, risperidone, iloperidone
Caution with all meds that may reduce seizure threshold
Potential interactions with many antidepressants
Safety/side effects
Insomnia, stomach upset, constipation, diarrhea, HTN
Most effective when used with Nicotine Replacement therapy patch plus lozenge or gum
Start 2 weeks before quit date

13. Varenicline (Chantix)
Alpha4beta2 nicotine acetylcholine agonist
Titrate up from 0.5 mg/day to 1.0 BID over 1 week mg BID 3-6 months
Monitor weekly for a period of time
Interactions - no significant – excreted in urine
Safety/side effects: Nausea, diarrhea, headache, agitation, suicidal or homicidal thoughts
Lower dose to address side effects

14. Comparative Summary of Neuropsychiatric Side effects (remember withdrawal also has effects)
NicotinePatch
Buproprion
Varenicline
Placebo*
Abnormal Dreams
41%
43%
39%
35%
Anxiety 9%
10% 8% 6%
Agitation 4% 5%
Depressed Mood
Anthenelli et al, The Lancet, 2016

15. Comparative Summary of Side effects (remember withdrawal also has effects)
Nicotine Patch
Patch + lozenge
Bupropion
Bup +
lozenge
Varenicline
Placebo*
Nausea
4.3
7.9
3.8-16*
5.0
52*
16-19*
Local irritation
Skin 15%
Throat 2-7%
Throat 2%
Smith et al, 2009; *Nides et al 2006

16. Flow sheet for use of cessation medication/NRT
Developed based on
Evidence of efficacy and safety in general population
Evidence of efficacy and safety in people with behaivoral health disorders
Consider most effective options first: varenicline and combinations
Safety and patient choice also guide medication selection

17. Get smoker to their baseline for their behavioral health condition and initiating abstinence from substances. Then assess whether, in the past year, was this patient:
Suicidal or homicidal
Significantly depressed
Violent
Unwilling to attend regular doctor’s appointments to monitor medications
Under 18 years old
A Guide for Choosing Smoking Cessation Medication in Mental Illness/addiction Tailoring based on research evidence (ANTHENELLI 2016; Bader 2009; Fiore 2008; Piper 2009; Evins 2010; Hitsman 2009)
No to all
VARENICLINE
3. Does patient:
Smoke 20 or more cigarettes a day
Have a history of failure at serious quit attempts
Have nicotine withdrawal when patient stops smoking, or
Failure on single daily low dose of NRT
Yes to any
2. Does patient have a history of:
Mania
Anxiety disorder
Seizure
Eating disorder
Under 18 years old
No to all
Yes to any
No to all
BUPROPION + High dose
combination NRT
BUPROPION +Low dose combination NRT
Yes to any
4. Does patient:
Smoke 20 or more cigarettes a day
Have nicotine withdrawal when patient stops smoking, or
Have a history of failure at serious
Failure on single daily low dose of NRT
quit attempt
Yes to any
No to all
High dose combination NRT
Low dose combination NRT
Combination Nicotine Replacement Therapy (NRT):
High dose NRT: 21mg patch plus immediate release Low dose NRT: 14mg patch plus immediate release
Immediate release: gum, lozenge, spray or inhaler up to 8 X day at appropriate strength. (Gum and lozenge come in either 2mg or 4 mg strength.)

18. What about after people quit?
Some behavioral health medications may need to be adjusted with smoking abstinence
Chemicals in smoke (polynuclear aromatic hydrocarbons) speed hepatic metabolism of many medications
Serum concentrations of medications that are stable in smokers may rise following abstinence as hepatic metabolism slows
Affected enzymes are CYP 1A1, 1A2, and 2E1
Abstinence associated with 30-42% reduction in 1A2 activity over the first 1-3 days of abstinence
Haldol, Prolixin, Olanzapine, Clozapine, Mellaril, Thorazine, Asenapine
Caffeine is also metabolized through 1A2
Therapeutic drug monitoring and 10% dose reduction for these meds has been recommended
Nicotine in NRT does not change metabolism
Monitor… for adverse effects, relapse to smoking

19. keep trying: Your persistence will help people quit
Many people take a long time to quit, or quit  relapse  try to quit again
Encourage people to keep trying, many people need several tries
Adjust (usually increase) dose for increased efficacy or switch cessation meds to address side effects
Encourage cessation counseling – people need to learn skills to resist urges to smoke
Teach stress management skills – people may relapse under stress
Use combinations if hasn’t been tried:
NRT combination; bupropion + NRT combo; varenicline + NRT

20. summary NRT and medications double or triple success of quit attempts
NRT and medications are not addictive and are safe for people with behavioral health disorders
Encourage behavioral intervention if not attending class/group – people need to learn skills to resist urges to smoke
Use combinations of cessation medications
Tailor treatment based on amount of smoking, timing of smoking, side effects and preferences
Be persistent! People may need to use for many months before they can quit. Meds prevent relapse after quit.

21. OTHER RESOURCES - WEBSITES
This site has a wide array of resources and links related to smoking cessation for people with mental illness. Included are lectures from various leaders in the field. This site has excellent lectures by Nancy Rigotti, Professor of Medicine at Harvard. Topics include motivational interviewing, pharmacotherapy, biology of nicotine. There are live patients with which you can interact to practice counseling strategies. This site has excellent lectures and simulated patients with a focus on smoking cessation in women and around pregancy. You can earn 4 CME credits for $25.

22. VIDEO LINKS FOR BRIEF LECTURES
Nicotine and nicotine withdrawal Nicotine replacement therapy Varenicline smoking cessation treatment for people with mental illness Quick facts about e-cigarettes for mental health and addiction clinicians

23. References Page 1 of 2
Anthenelli RM, et al. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet doi: /S (16) PubMed PMID: Bader P, McDonald P, Selby P. An algorithm for tailoring pharmacotherapy for smoking cessation: results from a Delphi panel of international experts. Tob Control 2009;18(1): Evins AE, Cather C, Pratt SA, et al. Maintenance treatment with varenicline for smoking cessation in patients with schizophrenia and bipolar disorder: a randomized clinical trial. JAMA. 2014;311(2): PMID: Fiore et al. Treating tobacco use and dependence Clinical practice guideline 2008 Update

24. References page 2 of 2
Fiore et al. Treating tobacco use and dependence Clinical practice guideline 2008 Update Gershon Grand RB et al. Short-term naturalistic treatment outcomes in cigarette smokers with substance abuse and/or mental illness. J ClinPsych 2007;68(6): Hitsman B, Moss TG, Montoya ID, George TP. Treatment of tobacco dependence in mental health and addictive disorders. Can J Psych ;54(6): Smith SS et al. A randomized placebo-controlled clinical trial of 5 smoking cessation pharmacotherapies. Arch Gen Psych 2009;66(11): Thurgood SL, McNeill A, Clark-Carter D, Brose LS. A Systematic Review of Smoking Cessation Interventions for Adults in Substance Abuse Treatment or Recovery. Nicotine Tob Res Tidey J. and Miller M. Smoking cessation and reduction in people with chronic mental illness BMJ 2015.