How to Address Tobacco

Disparity and Reduce

Dependence in Substance

Abuse Treatment Facilities

Jill M Williams, MD Director, Division of Addiction Psychiatry

Robert Wood Johnson Medical School

Disclosure

The faculty, Jill Williams, MD, has received grant funding from Pfizer, Inc. in the past

two years. Pfizer, Inc manufactures chantix. Dr. Williams will be discussing chantix

in her presentation.

The following people have no relevant financial, professional or personal

relationships to disclose:

CME/CNE Program Planner(s):

Robert Cohen, MD (CME Programs)

Marsha Marecki, EdD, WHNP-BC (CNE Programs)

Melanie Steilen, RN, BSN, ACRN (CNE Programs)

CME/CNE Program Reviewer(s):

Robert Cohen, MD (CME Programs)

Melanie Steilen, RN, BSN, ACRN (CNE Programs)

There are no commercial supporters of this activity. Accreditation status does not

imply endorsement by NJSNA, CAI, or ANCC of any commercial products or

services.

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Introduction/Presenter

Jill M. Williams, MD

Professor of Psychiatry

Director, Division of

Addiction Psychiatry

Rutgers- Robert Wood

Johnson Medical

School

New Brunswick,

Learning Objectives

• Review the high prevalence and consequences of tobacco use in

persons with other addictions.

• Discuss barriers that have prevented substance abuse staff from

addressing tobacco dependence in their clients

• Explain key concepts in brief assessments of tobacco dependence

including level of dependence and motivation to quit.

• Describe how treatment for tobacco dependence is an effective

method for increasing the success of quit attempts and the role a non-

prescriber can have in promoting treatment.

• Review evidence based treatments for tobacco dependence treatment

and how to integrate tobacco dependence treatment into recovery

plans.

Tobacco Use Rates in NJ

Addictions Treatment Settings

NJ ADADS 2001-2002

0

10

20

30

40

50

60

70

80

90

Tobacco Use Rates

US

NJ

Addictions

Residential

Methadone

Outpatient

Smoking Prevalence in

Addiction Treatment

• Review of 40 papers (over 20 years)

• Inpatient, outpatient, methadone programs

• Alcohol and drug treatment

• Median prevalence for a single year 76% (range 65% to 76%)

• Odds of smoking 2.25 times higher in methadone treatment as compared to other outpatient programs (Guydish, Passalacqua, Tajima, Chan, Chun & Bostrom, 2011)

Rationale Not to Treat Tobacco

Dependence in SUD Patients

• Not a real drug

• Fewer consequences / Not as disruptive to patients’ life

• Disruptive to SUD treatment

• Patients don’t want tobacco treatment

• Patients can’t quit smoking successfully

• Jeopardizes recovery from other substances

Not a Real Drug

0

100

200

300

400

500

600

700

800

900

1000

1100

0 1 2 3 4 5 hr

Time After Amphetamine

% o

f B

as

al R

ele

as

e

DA DOPAC HVA

Accumbens AMPHETAMINE

0

100

200

300

400

0 1 2 3 4 5 hr Time After Cocaine

% o

f B

as

al R

ele

as

e

DA DOPAC HVA

Accumbens COCAINE

0

100

150

200

250

0 1 2 3 hr

Time After Nicotine

% o

f B

as

al R

ele

as

e

Accumbens Caudate

NICOTINE

Source: Di Chiara and Imperato

Effects of Drugs on Dopamine Levels

Fewer Consequences; Not Immediate

• More alcoholics die from smoking

related diseases than from alcohol

related diseases

• Synergistic effects of alcohol and tobacco

↑ risk of developing pancreatitis and oral

cancers

• Smoking reduces recovery from cognitive

deficits during alcohol abstinence

Hurt et al, 1996; USDHHS 1982 Durazzo et al, 2007

Disruptive to SUD Treatment

• No increase in irregular discharges when

residential SUD settings went TF(NJ)

• ↑ Clients enrolled in treatment when facility

went TF (Kotz et al, 1993)

• Longer LOS when patients enrolled in smoking

cessation program (Burling et al., 1991).

• No increase in early discharges (Joseph, 1993).

Williams et al, 2005

2001 NJ Integration of Tobacco

Dependence Treatment into

Residential Substance Abuse

Treatment • In 1999, NJ established NJAC 8:42A

• Required residential addictions programs

– To provide tobacco assessment and treatment

– Prohibited tobacco products on the grounds of

facilities.

• Full implementation by Nov 2001.

• The state provided free nicotine patches and

gum to clients in these settings

• UMDNJ training and consultation

Staff shall not use

alcohol, tobacco or illegal

drugs during working

hours or when

representing the

treatment facility.

8:42A-3.5 (b) 1

Advantages of Addressing Tobacco

During Early Substance Recovery

• Structured environment focused on recovery

• Staff and peer support readily available

• Patients may be more motivated, believing this is the best time to quit

• Smoking quit rates in early substance recovery are the same as when treatment is delayed 6 mos (Joseph et al.,2003).

• Financial advantages if clients lack insurance

Joseph et al., 1990; Irving et al., 1994; Sees and Clark, 1993; Saxon et al.,

1997; Seidner et al., 1996; Foulds & Doverty, 2003: Joseph et al., 2002

Did the NJ 2001 implementation of the

Tobacco Provisions of the Licensure Standards result in an increase in premature client

discharges?

• NO

• There was no increase in irregular discharges.

• Rates were not statistically significant from discharge rates in previous years.

• The rates of irregular discharge were also not statistically significant between smokers and non-smokers.

Williams et al, 2005

Figure 1: Percent of New Jersey residential addictions treatment agencies reporting

tobacco-related activities before (1999) and after (2002) statewide Tobacco Licensure

Standards (n=30)

37

50

27

17

50

40

9097

87

67

87

73

0

20

40

60

80

100

Tob

acco

Ass

essm

ent

Tob

acco

Cou

nselin

g

NRT A

vaila

ble

Tob

. in D

isch

arge

Pla

n

Staff T

rain

ed o

n Tob

acco

Wri

tten

Sta

ff T

ob. P

olic

y

%

rep

orti

ng

acti

vit

y

1999

2002

Foulds et al., 2006

NJ Policy Resulted in Increased

Tobacco Treatment

03,5007,000

10,50014,00017,50021,00024,50028,00031,50035,000A

ug

No

v

Fe

b

Ma

y

Au

g

No

v

Fe

b

Ma

y

Au

g

No

v

Time Period

# A

dm

iss

ion

s

Total For All Major Program Types

August 2007 to December 2009

No Reduction in Program Admissions

Total For All Major Program Types OASAS NY

Tobacco-Free Implementation - July 2008

www.oasas.ny.gov

Patients Resistant to Tobacco

Treatment

• Two-thirds of smokers wanted to stop (41%) or cut down on tobacco use (24%) at time of admission to residential addictions treatment Williams et al, 2005

• Patients highly interested in treatment and believe inpt treatment is best time Orleans & Hutchinson, 1993; Shoptaw et al., 2002; Richter et al, 2001;

Nahvi, et al, 2006; Sees & Clark, 1993; Clemmey et al, 1997; Frosch et al, 1998; Clarke et al 2001; Joseph et al., 1990; Saxon et al., 1997; Joseph et al., 2002

Patients with SUD Can’t Quit Smoking

• H/o ETOH Just as likely to

succeed in quitting smoking as

other smokers

• Usual treatments effective

• Smokers learned skills in

recovering from alcohol that

helped them quit smoking

Hughes & Kalman, 2006

Lifetime Quitting

• Smokers with current alcohol

problems, were less likely to

have quit in their lifetime than

smokers with no problems

• ? Fewer quit attempts

Hughes & Kalman, 2006

Jeopardizes Recovery from other

Substances

• Several studies show no adverse effects on abstinence

Bobo et al. 1996, 1998; Hurt et al., 1994; Cornelius et al. 1997, 1999; Prochaska et al. 2004; Lemon et al, 2003; McCarthy et al, 2002; Shoptaw et al., 2002

• Quitting smoking may help with long-term abstinence from alcohol and other drugs

Smoking Cessation Treatment Does Not

Jeopardize Recovery from other Substances

META ANALYSIS OF 19 RANDOMIZED CONTROL

TRIALS WITH INDIVIDUALS IN CURRENT

ADDICTION TREATMENT OR RECOVERY

• SMOKING CESSATION INTERVENTIONS PROVIDED

DURING ADDICTIONS TREATMENT WERE

ASSOCIATED WITH A 25% INCREASED LIKELIHOOD

OF LONG-TERM ABSTINENCE FROM ALCOHOL AND

ILLICIT DRUGS

• SMOKING CESSATION WORKED WELL INITIALLY BUT

WAS DIFFICULT TO SUSTAIN IN THE GROUPS

• IN THE LATER STUDIES WHICH USED NRT’S,

SUCCESS WAS INCREASED

PROCHASKA ET AL JCCP 2004

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

Tobacco Treatment Availability

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

• 41% offer smoking cessation counseling or pharmacotherapy

• 38% offer individual/group counseling

• 17% provide quit-smoking medication

• More likely : medically oriented, more comprehensive services, recognize the health burden of smoking

Friedmann et al., JSAT 2008

Twelve Steps to Addressing Tobacco within

Addiction Treatment Programs

1. Acknowledge the Challenge to Address the Barriers and Integrate the Solutions

2. Establish a Leadership Group and Make a Commitment to Change

3. Create a Change Plan and Realistic Implementation Timeline

4. Start with easy program and system changes, including tobacco policies

5. Conduct Staff Training

6. Assess and Document in charts nicotine use, dependence, and prior treatments

7. Incorporate Tobacco Issues into all client education curriculum

8. Provide Medications for Nicotine Dependence Treatment

9. Provide treatment and recovery assistance for interested nicotine dependent staff

10. Integrate Motivation-Based Treatments throughout the program

11. Establish ongoing communication with 12-Step Recovery Groups, Professional Colleagues, and Referral Sources about system changes

12. Consider additional Addressing Tobacco Policies, including Smoke-Free Grounds

Assessment

• Level of Nicotine Dependence

• Motivation to Quit • First age smoked

• Years smoked

• Current amount

• Tobacco types (pipes, cigars, smokeless)

• Smokers in household

• Consequences of use- health or other

Tobacco Use Disorder

– withdrawal

– tolerance

– desire or efforts to cut down/ control use

– great time spent in obtaining/using

– reduced occupational, recreational

activities

– use despite problems

– larger amounts consumed than intended

– Craving; strong urges to use

Most tobacco users are addicted (2 or more)

DSM-5

Nicotine

Pharmacology

Pharmacology depends on delivery route

Reaches brain in 10 sec

Arterial levels 6-10x higher than venous

Half-life 2 hours

Metabolized to cotinine in liver

Russell et al., BMJ, 1983

Tobacco Withdrawal

Depressed mood

Insomnia

Irritability, frustration or anger

Anxiety

Difficulty concentrating

Restlessness

Increased appetite or weight gain

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 in Addiction Treatment are

Moderately to Severely Addicted to

Nicotine

0

5

10

15

20

25

30

35

40

45

50

0-5 min 6-30 min >31

0-5 min

6-30 min

>31

N=1882 smokers in NJ addictions treatment, 2001-2002;

Williams et al., 2005

MORE Nicotine Dependence

and Withdrawal in SUD

• Current, past or lifetime alcohol problems were associated with ↑nicotine dependence

• Smokers with SUD are more likely to report withdrawal symptoms

• Smokers with SUD have ↑likelihood of withdrawal-related discomfort and smoking relapse

Hughes & Kalman, 2006; Weinberger 2010

READINESS to QUIT in SPECIAL POPULATIONS

48%

41%

55%

43%

40%

22%

24%

24%

28%

20%

0% 20% 40% 60% 80% 100%

Methadone Clients

Psych. Inpatients

Depressed Outpatients

General Psych Outpts

General Population

Intend to quit in next 6 mo Intend to quit in next 30 days

* 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

Hard to Quit

Without

Treatment

70% of smokers report wanting to quit someday

Few people quit successfully without treatment

Only 1/3 of quitters (without treatment) remain

abstinent for 2 days

< 5% ultimately successful

on a given quit attempt

Pharmacological Treatment

Rationale

Reduce or eliminate withdrawal

Block reinforcing effects of nicotine

Manage negative mood states

Unlearn smoking behaviors

Cost-effective treatment

Lessen/delay weight gain

First-line Treatments

(FDA Approved)

• Nicotine Replacement

• Bupropion

Zyban/ Wellbutrin

• Varenicline

Chantix

Nicotine Medications

• Not a carcinogen

• Use high enough dose

• Scheduled better than PRN

• Use long enough time period

• Can be combined with bupropion

• Can be combined with each other

• Have almost no contraindications

• Have no drug-drug interactions

Nicotine Replacement • Smokers misinformed about safety/efficacy

• Risk-benefit ratio nicotine > tobacco

NRT for Smokers with Addictions

No reason not to use

Not introducing a “new drug”

Safer nicotine delivery vs. smoking

More patient education

Off-label ?? Longer time

?? Use when continuing to smoke small

amounts

Pharmacological Treatment

Nicotine Replacement Patch

Gum

Lozenge

Inhaler

Nasal Spray

Bupropion

Varenicline

Combination Therapies

Improves abstinence rates

Decreased withdrawal

Well tolerated

Kornitzer 1995

A randomized placebo-controlled clinical trial

of five smoking

cessation pharmacotherapies

• 1504 smokers

• 5 treatments and 5 placebo groups – nicotine lozenge

– nicotine patch

– bupropion SR

– nicotine patch + nicotine lozenge

– bupropion + nicotine lozenge

Piper et al., 2009

Odds Ratio for 6 months after Quit

Date

0

0.5

1

1.5

2

2.5

Loz

NP

Bup

Bup + Loz

NP + Loz

NP + Loz greatest time to relapse

all monotherapies > placebo

Smoking with NRT

• Relatively safe

• Harm Reduction

• Less reinforcing effects

• Withdrawal of treatment=punishment

for relapsing

Cut Down To Quit (CDTQ)

• NRT previously licensed in the UK for

quitting have recently been granted a new

licensed indication called ‘cut down to quit’

(CDTQ).

• Aims at smokers unwilling or unable to

stop smoking in the short term

• Gradually to cut down smoking over an

extended period while taking NRT

• Gum and inhaler

Wang et al., 2008

NRT Assisted Reduction

• 7 Smoking Reduction trials (four Nicotine gum, two inhaler, and one free choice NRT)

• 2767 smokers

• NRT for 6-18 months

• 6.75% of smokers receiving NRT had sustained abstinence for six months, 2X more those receiving placebo

• No statistically significant differences in adverse events and discontinuation because of adverse events

except nausea →more with NRT

• Whether smokers are motivated to reduce then quit or simply motivated to reduce may make little difference to the efficacy of NRT for smoking cessation Moore et al., BMJ, 2009

First-line Treatments

(FDA Approved)

• Nicotine Replacement

• Bupropion

Zyban/ Wellbutrin

• Varenicline

Chantix

Bupropion SR

• Start 150mg/day to dose of 150mg bid

• Nonsedating, activating antidepressant with effects on NE and DA systems

• Start 10-14 days prior to quit date

• Side effects- headache, insomnia

• Contraindicated in h/o seizures or bulemia

• Noncompetitive nicotinic receptor antagonist

Slemmer 2000

Varenicline Summary

• Selective a4B2 nicotinic

receptor partial agonist

• No drug-drug interactions

• Precaution in ESRD

• Dosed with food to reduce

nausea

Varenicline: a selective a4B2

nicotinic receptor partial agonist

Mesolimbic

system

Nucleus

accumbens

Ventral tegmental

area

Dopamine

Varenicline

Partial Agonist

• Partially stimulates receptor

• Some DA release at NAcc

• Prevents withdrawal

“Antagonist”

• Blocks nicotine binding a4B2

**Don’t use as combination

Varenicline vs Nicotine Patch

• Open label (N=776)

• 12 Week varenicline vs 10 week NP

• Nausea: varenicline (37%) > NP (10%)

Aubin et al., 2008 Continuous Abstinence, Week 9-12 Week 52

Varenicline and Alcohol

• No DB-PC studies

• Open-label, > 6 months sober

– 31% quit at 12 weeks (7dPP)

– No serious adverse events

• Short-term lab studies of heavy drinkers

– Smoked less on varenicline vs. placebo

– Had less alcohol craving and fewer heavy

drinking days on varenicline vs. placebo

• Varenicline reduces alcohol intake in rats

Hays 2011; McKee 2009; Fucito

2011

Varenicline Labeling Updates

Warning (Reported with Chantix)

Observe patients for serious

neuropsychiatric symptoms including

changes in behavior, agitation, depressed

mood, suicidal thoughts or behavior

Worsening of preexisting psychiatric

illness

Causal relationship not established

Clinical trials (N>5000; SI rate = placebo)

Sleep disturbance/ vivid dream www.PfizerPRO.com/chantix

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

Case Report Data

• Review of FDA's Adverse Event

Reporting System (AERS)

• Case reports for varenicline, bupropion

and NRT

• Suicidal/self-injurious behavior or

depression highest in varenicline group

• Not controlled, randomized studies

• Re-report of same case report data

Moore et al., 2011

Bupropion Adverse Effects French dataset: 700,000 patients

1682 cases of adverse reactions were reported

~ 1/3 of these involved SAR

Allergic reactions (31.2%), including angioedema and serum sickness-like reactions.

Serious neurological reactions were frequent (22.5%), mostly comprising seizures; almost half of these patients had history seizures or other risk factors.

Serious neuropsychiatric adverse events reported (17.3%), suicide attempts/suicides were a cause for concern, although risk factors (history of depression, suicide attempts, etc.) were described for 66% of patients experiencing these events.

Beyens et al., 2008

Medication Interactions with

Tobacco Smoke

• Smoking ↑ P450 enzyme system

• Polynuclear aromatic

hydrocarbons (tar)

• ↑ 1A2 isoenzyme activity

• Smoking ↑ metabolism of meds

– ↓ serum levels

• Smokers on higher medication

doses

Drugs Reduced by Smoking

Antipsychotics

Olanzapine Clozapine

Fluphenazine, Haloperidol, Chlorpromazine

Antidepressants Amitriptyline, doxepin, clomipramine, desipramine,

imipramine, fluvoxemine

Others Caffeine, theophylline, warfarin, propranolol,

acetominophen

Desai et al., 2001; Zevin & Benowitz 1999

Quitting Smoking

• Risk for medication

toxicity

• May ↑ levels acutely

• Consider dose

adjustment

• Clozapine toxicity

– Seizures

• Reduce caffeine

intake

• Nicotine (or

NRT) Does Not

Change

Medication Levels

• Nicotine

metabolized by

CYP2A6

Conclusions

• Medications should be used for all smokers

• No contraindication to NRT for outpatient smokers with other addictions

• Bupropion advantage in depressed smokers- two indications

• Varenicline more effective than other medication treatments

• Combinations more effective

Questions?