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Prevalence of Alcohol Use Prevalence of Alcohol Use DisordersDisorders
Alcohol DependenceAlcohol Dependence 7.9 million (3.8%)7.9 million (3.8%)
Alcohol AbuseAlcohol Abuse 9.7 million (4.7%)9.7 million (4.7%)
NIAAA= National Institute on Alcohol Abuse and AlcoholismGrant BF, et al. Arch Gen Psychiatry. 2004;61:807-816.
Any Alcohol Use DisorderAny Alcohol Use Disorder17.6 million (8.5%)17.6 million (8.5%)
NIAAA – National Epidemiologic Survey onNIAAA – National Epidemiologic Survey onAlcohol and Related Conditions (NESARC)Alcohol and Related Conditions (NESARC)
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Epidemiology of Use and AbstentionEpidemiology of Use and Abstention
0
10
20
30
40
50
60
70
80
18-24 25-44 45-64 > 64
Drank past year
Lifetime abstainer
P
erce
nt
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Epidemiology of Heavy UseEpidemiology of Heavy Use
0
2
4
6
8
10
12
14
16
18-24 25-44 45-64 > 64
Heavy Use
Women: > 1 drink / day Men: > 2 drinks / day
Per
cen
t
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0
5
10
15
20
25
18-29 30-44 45-64 65+ 18-29 30-44 56-64 65+
Pe
rce
nt
Abuse Dependence
Men Women
12-mo. Prevalence of DSM-IV AUD Diagnoses
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Medications Approved in the Medications Approved in the US for Treatment of Alcohol US for Treatment of Alcohol
DependenceDependence
Disulfiram (Antabuse): 1949Disulfiram (Antabuse): 1949 Naltrexone (ReVia): 1994Naltrexone (ReVia): 1994 Acamprosate (Campral): 2004Acamprosate (Campral): 2004 Long-Acting Naltrexone (Vivitrol): Long-Acting Naltrexone (Vivitrol):
20062006
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NaltrexoneNaltrexone
Non-specific opioid receptor antagonistNon-specific opioid receptor antagonist Dose dependent binding to Dose dependent binding to , , and and
opioid receptorsopioid receptors FDA approved as adjunctive FDA approved as adjunctive
pharmacotherapy for the treatment of pharmacotherapy for the treatment of alcoholism alcoholism
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OpioidsOpioids Acute alcohol increases plasma Acute alcohol increases plasma -Endorphin -Endorphin
levels levels
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OpioidsOpioids Opioid antagonists reduce alcohol drinkingOpioid antagonists reduce alcohol drinking
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Clinical trialsClinical trials
Naltrexone has been shown to Naltrexone has been shown to Increase percentage of days abstinent from Increase percentage of days abstinent from
alcoholalcohol Reduce number of drinks/drinking dayReduce number of drinks/drinking day Increase time to relapseIncrease time to relapse Decrease craving for alcoholDecrease craving for alcohol
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Naltrexone (Revia) in the Treatment of Naltrexone (Revia) in the Treatment of Alcohol DependenceAlcohol Dependence
Number of Weeks Receiving Medication
10 2 3 4 5 6 7 8 9 10 11 120.00.1
0.2
0.40.50.60.70.80.9
1.0
0.3
Cum
ulat
ive
Pro
port
ion
with
No
Rel
apse
Naltrexone (N=35)
Placebo (N=35)
Volpicelli et al., Arch Gen Psychiatry, 1992
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Effect of Long-Acting Naltrexone on Effect of Long-Acting Naltrexone on Maintenance of AbstinenceMaintenance of Abstinence
0102030405060708090
100
Per
cent
with
out R
elap
se
p < 0.025
Placebo (n = 28) Vivitrex (n = 28)
Subjects with 4-day lead-in abstinence
1 2 3 54 6 7 8 109 11 12 13 1514 16 17 18 2019 21 22 23 2524 26 27 28 3029 31
Weeks
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COMBINE COMBINE (Anton et al., 2006)(Anton et al., 2006)
ASAM, 2007
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VA cooperative studyVA cooperative study
From Krystal et al 2001
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Cochrane review Cochrane review (Srisurapanont and Jarusuraisin 2002)(Srisurapanont and Jarusuraisin 2002)
NTX treatment can decrease the chance of NTX treatment can decrease the chance of alcohol relapse for 36% as compared to placebo alcohol relapse for 36% as compared to placebo treatment. In addition, the treatment is likely to treatment. In addition, the treatment is likely to reduce the chance of returning to drinking for 13%.reduce the chance of returning to drinking for 13%.
Short-term treatment of NTX for alcoholism gives Short-term treatment of NTX for alcoholism gives a meaningful benefit in preventing a relapse. a meaningful benefit in preventing a relapse.
Small to Modest efficacy!Small to Modest efficacy!
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Identifying predictors of robust Identifying predictors of robust treatment response to naltrexone treatment response to naltrexone
could improve clinical practice could improve clinical practice
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Potential predictors of naltrexone Potential predictors of naltrexone responseresponse
Family history of alcoholism Family history of alcoholism Monterosso et al., 2001; Rubio et al., 2005Monterosso et al., 2001; Rubio et al., 2005
OPRM1 OPRM1 opioid receptor gene polymorphisms opioid receptor gene polymorphisms Oslin et al., 2003Oslin et al., 2003
Age of onset of alcohol abuse Age of onset of alcohol abuse Rubio et al., 2005Rubio et al., 2005
Antisocial traits and heavier drinkersAntisocial traits and heavier drinkers Rohsenow et al., 2007Rohsenow et al., 2007
Higher level of alcohol craving Higher level of alcohol craving Volpicelli et al., 1995Volpicelli et al., 1995
Consistent drinking patterns Consistent drinking patterns Gueorguieva et al 2007Gueorguieva et al 2007
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Laboratory modelsLaboratory models Human clinical laboratory paradigms can Human clinical laboratory paradigms can
be used to model a variety of behaviors in be used to model a variety of behaviors in controlled conditions. controlled conditions. Careful experimental manipulations to Careful experimental manipulations to
understand the mechanisms underlying a understand the mechanisms underlying a behavior. behavior.
Can be used to evaluate medication signals Can be used to evaluate medication signals following a shorter treatment periodfollowing a shorter treatment period
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Laboratory models-Alcohol Laboratory models-Alcohol In the field of alcohol research, controlled In the field of alcohol research, controlled
human laboratory studies have been human laboratory studies have been used to study used to study different populations of drinkers different populations of drinkers
• (e.g., social drinkers, dependent drinkers, women, (e.g., social drinkers, dependent drinkers, women, high-risk individuals), high-risk individuals),
different types of cues different types of cues • (e.g., stress, social drinking, solitary drinking, (e.g., stress, social drinking, solitary drinking,
peer influences), peer influences), different types and schedules of alcohol different types and schedules of alcohol
• (e.g., beer, wine, hard liquor, IV alcohol; fixed (e.g., beer, wine, hard liquor, IV alcohol; fixed doses, scheduled administration, ad-lib drinking). doses, scheduled administration, ad-lib drinking).
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Laboratory models to study alcohol-Laboratory models to study alcohol-naltrexone interactionsnaltrexone interactions
Human laboratory-based paradigms have Human laboratory-based paradigms have been used to evaluate naltrexone’s been used to evaluate naltrexone’s effects ineffects in Social drinkers Social drinkers
• e.g. Swift et al 1994, King et al 1997 e.g. Swift et al 1994, King et al 1997 Non-treatment seeking alcohol dependent Non-treatment seeking alcohol dependent
drinkers drinkers • e.g. Anton et al 2004; Drobes et al 2004, e.g. Anton et al 2004; Drobes et al 2004,
Krishnan-Sarin et al 2007, O’Malley et al 2002 Krishnan-Sarin et al 2007, O’Malley et al 2002 Importantly, effects observed in laboratory Importantly, effects observed in laboratory
studies similar to those seen in clinical trialsstudies similar to those seen in clinical trials
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Alcohol Self-Administration Model (O’Malley, Krishnan-Sarin et al., 2002)
4 pm
Choice Block #1
5:00 pm
OutpatientTreatment
Priming Drink
Alcohol Reactivity
• craving
Ad-Lib Period
•4 drinks per choice period (.015 g/dl)
•$12 tab per choice period
(.03 g/dl)
Naltrexone pretreatment
Choice Block #2
6:00 pm 7 pm
Day 0
Day 6 Day 7
MET Intervention Discharge
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Figure 1
Naltrexone Dose
# of
dri
nks
+ S
E
0
2
4
6
FH +FH -
0
2
4
6 C: Females only
B: Males only
N=3 N=3N=4
N=5
N=3N=4
N=16
N=18 N=10N=7
N=9
N=10
# of
dri
nks
+ S
E
0
2
4
6
# of
dri
nks
+ S
E
A: Males and Females
N=12
N=19
N=12
N=21
N=14
N=14
0 mg 50 mg 100 mg
From Krishnan-Sarin et al., 2007
Naltrexone and FH of alcoholism