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![](3D"slide0017_image001.gif")
An
Evidence-Based Clinician’s Guide to the New Pharmacothe=
rapies
for Alcoholism
Barbara J. Mason, Ph.D.
Pearson Family Professor,
Committee on the Neurobiology of Addictive Disorders
<=
/b>
Co-Director, The Pearson Center for Alcoholism and Addicti=
on
Research
Tel: 858-784-7324; E-mail: mason@scripps.edu
![](3D"slide0017_image003.gif")
Financ=
ial
Disclosure
Dr. Mason serves or has served as a consultant and=
/ or
member of the speakers bureau for Lipha, Merck, Fo=
rest,
DuPont, and Alkermes.
The To=
ll of
Alcohol Dependence
•Over 8.1 m=
illion
alcohol-dependent people in the United
States
•<=
/span>Economic cost: $185 billion per year
•<=
/span>100,000 deaths per year
•
•
•
•
•From: Fuller, R.K., Gord=
is,
E.
•Editorial: Naltrexone
Treatment for Alcohol Dependence
•NEJM 345:1770-1771, 2001=
•
“Relapse prevention is the central concern of alcoholism treatment.”
Enoch Gordis, M.D.
Former Director,
National Institute= on Alcohol Abuse and Alcoholism
Enoch Gordis, M.D.
Former Director,
National Institute= on Alcohol Abuse and Alcoholism
![](3D"slide0167_image005.gif")
Converging Acute Actions of Drugs of =
Abuse on the Ventral
Tegmental Area and Nucleus Accumbens
From: Nestler EJ, Nat Neurosci, 2005, 8:1445-1449.
![3D"Cycle](3D"slide0156_image006.gif")
Cycle =
of
Alcoholism
Protracted
Withdrawal
Binge/
Intoxification
Acute
Withdrawal
Goals
for Pharmacotherapy in
Alcohol Dependence
Alcohol Dependence
•<=
/span>reduce the intensity of binges
<=
/div>
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•
•<=
/span>assist in abstaining from use
•
•decrease u=
rges
to drink
•
•normalize
dysregulated brain systems
•
•reduce sym=
ptoms
associated with relapse, e.g., negative
affect, insomnia
FDA-Approved Medications for <= br> Alcohol Dependence
1994-present
<=
span
style=3D'font-weight:normal;visibility:hidden'>•
<=
span
style=3D'font-size:75%;font-weight:normal'>•Naltrexone
(ReVia) 1994
<=
span
style=3D'font-size:75%;font-weight:normal'>•Acamprosate
(Campral) 2004
<=
span
style=3D'font-size:31%;font-weight:normal;visibility:hidden'>•
Similarities
Between
Acamprosate and Naltrexone
Acamprosate and Naltrexone
<=
span
style=3D'font-size:75%;font-weight:normal'>•demonstrat=
ed
efficacy relative to placebo
<=
span
style=3D'font-size:75%;font-weight:normal'>•well
tolerated
<=
span
style=3D'font-size:75%;font-weight:normal'>•no interac=
tion
with alcohol
<=
span
style=3D'font-size:75%;font-weight:normal'>•no abuse
liability, tolerance or rebound effects
<=
span
style=3D'font-size:75%;font-weight:normal'>•acceptable=
to
alcoholics
<=
span
style=3D'font-size:75%;font-weight:normal'>•not a
panacea
Differences
Between
Acamprosate and Naltrexone
Acamprosate and Naltrexone
•may act on
different behavioral aspects of alcoholism
<=
span
style=3D'font-size:75%;font-weight:normal'>•have diffe=
rent
safety and adverse event profiles
Mechan=
isms
of Action
•Naltrexone
•Neural
pathway: endogenous opioid
system
•Functional
antagonist: reduce rewarding
effects of drinking
•
•Acamprosate
•<=
/span>Neural pathway:&n=
bsp;
glutamate (NMDA)
•Taurine an=
alog:
normalizes alcohol-induced hyperexcitability
•
Naltr=
exone
•
•Summary of
Double-Blind, Place=
bo-Controlled
•Clinical Trials=
Naltrexone
50 mg/d:
Rate of Total Abstinence
Rate of Total Abstinence
![](3D"slide0080_image008.gif")
3 mos.
Naltrexone
50 mg/d:
Relapse to Heavy Drinking
Relapse to Heavy Drinking
![](3D"slide0069_image010.gif")
*
*
*
*p &l=
t;
0.05
![3D"Text](3D"slide0069_image011.gif")
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12=
mos.
Commonly
Occurring Adverse Events (AE’s) in the Naltrexone Open Label Safety Study
(N =3D 570)*
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(N =3D 570)*
•Most common new-=
onset
AE’s
•Nausea 9.8=
%
•<=
/span>Headache 6.6%
•
•Discontinuations=
due
to AE’s 15.0%
•Primarily
nausea
•
•*Doses up to 200=
mg/d
Croop=
et
al. 1997
Summar=
y of
Benefits of Naltrexone
•Reduces ri=
sk of
relapse to heavy drinking
•
•<=
/span>Shows beneficial effects in short term treatment of
• alcohol dependence especiall=
y in
compliant patients
•
•Efficacy ma=
y be
facilitated by long-acting formulations
• that reduce non-compliance&#=
13;
•
•Effective =
in
difficult to treat populations
•
•<=
/span>Has a good safety profile
•
Risks =
and
Limitations of Naltrexone
•Short-acti=
ng
•
•Dose depen=
dent
hepatotoxicity: obtain baseline and follow
up liver function tests (LFT’s)
•
•<=
/span>Induces opiate withdrawal
•
•Reports of
increased depression in depressed patients
•
•Reports of
interaction with nonsteroidal anti-inflammatory
medications
•
•To optimize
therapy, compliance with medication should
be facilitated and cognitive behavioral therapy administered concomitantly
•
Acamp=
rosate
2g/d
•
•Summary of
Double-Blind, Place=
bo-Controlled
•Clinical Trials=
Acamprosate
International Double-Blind Trials
Rate of Total Abstinence
Rate of Total Abstinence
*
*
*
*
*
*
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*
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*
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*
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#8804;3 mos.
![3D"Text](3D"slide0042_image014.gif")
___
6 mos.
![3D"Text](3D"slide0042_image015.gif")
___
12 mos.
Acamprosate
International Double-Blind Trials
Days to First Drink<= /div>
![](3D"slide0043_im=)
=
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![3D"Text](3D"slide0043_image019.gif")
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PowerPoint Presentation
Adverse Events Reported in ≥ 3% of Patients Treated with Acamprosate Versus Placebo
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Days to First Drink<= /div>
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=
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=
12 mos.
Efficacy
of Acamprosate in Reduction of Drinking
•Mean Numbe=
r of
Drinks per Week*
•
• Acamprosate Placebo P
Value
•
•Day 30 12.36 20.27
<0.001
•
•Day 90 11.14 18.11
<0.001
•
•Day 180 10.5 16.03
<0.001
•
•Day 360 8.1=
2 21.35 =
;
<0.001
•
•
•*Data f=
rom
1010 patients who took ≥ 1 drink from 15 placebo-controlled studies =
; =
Chick=
et
al. 2003
Adverse Events Reported in ≥ 3% of Patients Treated with Acamprosate Versus Placebo
• <=
span
style=3D'font-size:63%'>Acamprosate Placebo
• (n =3D 2019) =
;
(n =3D 1706)
•
•Diarrhea 16% 10%
•
•Asthenia =
;
6% =
; &n=
bsp;
5%
•
•Nausea =
;
4% =
; &n=
bsp;
3%
•
•Pruritus =
;
4% =
; &n=
bsp;
3%
•
•Flatulence =
; &n=
bsp; =
;
3% =
; &n=
bsp;
2%
•
•
Campr=
al
package insert, Forest Pharmaceuticals
Summary=
of
Benefits of Acamprosate
•Reliably shows beneficial effects in the long term=
treatment of alcohol dependence across a range of behavioral therapies
• Shows sust=
ained
efficacy post treatment
• Has an exc=
ellent
safety profile
• Has no ser=
ious
adverse events
•Increases =
the
rate of abstinence relative to placebo
Risks a=
nd
Limitations of Acamprosate
•There are no observed health risks in >1.5 mill=
ion patients treated since 1989
•To optimize
therapy, patients should be motivated
to have abstinence as their treatment goal
On-Line
Resources for Alcoholism Treatment
Providers
•www.alco=
holfree.info Patient
education and self-help handouts
=
•
•www.asam=
.org Patient
assessment and levels of care criteria
•
•www.niaa=
a.nih.gov Clinician’s
guide to alcoholism treatment, Project MATCH, <=
span
style=3D'mso-tab-count:1;width:3.93%'> <=
span
style=3D'font-size:63%'> COMBINE
manuals
•
•www.alcoho=
lics-anonymous.org AA
Physicians members
• guide to medications
•
•www.aaap=
.org Subspecialty
information <=
span
style=3D'font-size:63%'> regarding
addiction psychiatry
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oobG/MIND/dia1/053006jh