DRINKING HABITS - Self-rating Scale (1)I use to drink:
1. When I meet someone
2. When I have some trouble, to forget them
3. Out of habit
4. For the taste
5. For the taste which became a habit
6. It's a family habit
7. To pep up
8. In the company of my spouse
9. Because I like to drink
10. When I feel lonely
11. To raise my morale
12. To avoid trembling the day after a bout of heavy drinking
13. For professional reasons
14. When I feel abandoned
Each item is rated as:0 = never 1 = seldom2 = sometimes 3 = frequentlyaccording to the global situation during the last 6 months
DRINKING HABITS - Self-rating Scale (2)I use to drink:
15. When I have problems which I can't tolerate
16. With a meal
17. When I find myself with a group of drinkers
18. To feel better
19. Before doing something
20. To kill time
21. In the evening to relax
22. To pick me up
23. When I am offered a drink
24. When I feel isolated
25. To be in a good mood when I am with other people
26. When I am bored
27. When I am busy with something
28. When I feel tense, anxious
29. Before meeting someone
Each item is rated as:0 = never 1 = seldom2 = sometimes 3 = frequentlyaccording to the global situation during the last 6 months
DRINKING HABITS - Self-rating Scale (3)I use to drink:
30. When I feel down
31. When I am in a particular surrounding
32. I enjoy drinking
33. To show that I can drink as much or more than anyone
34. To be less anxious, the day after a bout heavy drinking
35. When I am influenced by others to drink
36. When I have to do something unusual
37. To be different from my everyday self
38. Before speaking to certain persons
39. To avoid feeling lousy, the day after a bout of heavy drinking
40. As an escape, to avoid reality
41. To feel more selfassured in certain situations
42. To isolate myself
43. When I feel tired, exhausted
44. After the first drink I can't stop
45. To help me fall asleep at night
Each item is rated as:0 = never 1 = seldom2 = sometimes 3 = frequentlyaccording to the global situation during the last 6 months
MODES OF DRINKING: ALCOHOLISM
1. SOCIAL:in a social setting
2. HABIT:from habit, for the taste
3. STRESS:to escape psychological difficulties
4. PHYSICAL DEPENDENCE:to avoid withdrawal symptoms
5. STIMULUS:as a stimulus for activity, for assertiveness
Each mode is rating on a 4 level scale, validated for timeand interrater reliability:0 = never 2 = sometimes1 = seldom 3 = frequently
ANGER 70 %
This person feels angerThis person feels anger
1 2 3 4 5 6 7Not at allNot at all Very intensivelyVery intensively
INTENSITY SCORES AS FUNCTION OF GROUP AND FACIAL EXPRESSION
Note. * p<.05; ** p<.01 Kornreich et al. (2001) Journal of Studies on Alcohol
Emotional Facial Expressions
0
0,5
1
1,5
2
2,5
3
3,5
4
Happiness Anger Sadness Disgust Fear
Normal Controls
Abstinent Alcoholics
Recently detoxified Alcoholics
*
** **
** **Intensity
scores
9,47(0,53)
8,93 (1,14)
9,33 (0,71)
5,13 (1,62)
0
1
2
3
4
5
6
7
8
9
10
Serial recall Alphabetical RecallCondition
Controls
Alcoholics
*
COMPARISONS BETWEEN PERFORMANCES ON THE SERIAL AND THE ALPHABETICAL
RECALL SCORES ON THE ALPHA-SPAN TEST
Effect of group: F1,58=43.6, p<.001; Effect of condition: F1,58=90.9, p<.001 Interaction between group and condition: F1,58=54.6, p<.001* Post-hoc analysis indicated that ALC performed lower only in alphabetic recall (p<.01)
Score
AVERAGE NUMBER OF ERRORS MADE BY ALCOHOLICS AND CONTROLS
ON THE HAYLING TEST
0,2
4,2
0,23
8
0
1
2
3
4
5
6
7
8
9
Initiation (Section A) Inhibition (Section B)Condition
Controls
Alcoholics
***
Note. *** p<.001
Points
of
penalty
RELATIONSHIP BETWEEN POSITIVE AND NEGATIVE REINFORCEMENT
drug POSITIVE REINFORCEMENTchemical drug reward Glu, GABA, DA/endorphins
drugdrugadapt
adapt CHRONIC DRUG TOLERANCEneurochemical adaptation Glu RS, GABAA Rs, ? DA/Es
drug adapt adaptNEGATIVE REINFORCEMENTexposure of neuronal adaptationearly minor signs of withdrawal
adaptationWITHDRAWAL SIGNSuntil adaptation is removed
DETOXIFICATION IS RELATIVELY EASYDETOXIFICATION IS RELATIVELY EASYMAJOR THERAPEUTIC PROBLEMS BEGIN HEREMAJOR THERAPEUTIC PROBLEMS BEGIN HERE
CONDITIONING OF REINFORCEMENTS = CRAVING?
+ CUE + CUE + CUE
D D D Repeated pairing"conditions"associated stimulus ("cue")
CUE
POSITIVE ASPECTS OF CRAVINGConditioned stimulus (cue) elicits anticipation of drug rewarde.g. relaxation, euphoria, excitement
+ CUE + CUE + CUE
DD
D Cue becomesconditionedstimulus for adaptation
CUE
NEGATIVE ASPECTS OF CRAVINGConditioned stimulus (cue) elicits "pseudo-withdrawal"e.g. anxiety, dysphoria, depression, tremor, etc.
AA
A
A
THE MECHANISMS OF ALCOHOL DEPENDENCE
Adaptation to alcohol as the basis for the Withdrawal SyndromeAdaptation to alcohol as the basis for the Withdrawal Syndrome
Excitation
InhibitionAlcohol administration Withdrawal
Acute effect
Withdrawalsyndrome
Development of tolerance
Littleton JM.Addiction, 1995
Immediate CNS depressant effects of ethanol become limited by neurochemical adaptation
Exposure of adaptation causes hyperexcitation
Campral®: A NOVEL ACTION IN
ALCOHOL DEPENDENCENORMALNORMAL CHRONIC ALCOHOLISMCHRONIC ALCOHOLISM
BALANCE
WITHDRAWALWITHDRAWAL CRAVINGCRAVINGHYPEREXCITATION
BALANCE
Inh Exc Inh Exc
BAR Alc+
Exc BRAIN+
BAR AlcInh
Exc
Exc BRAIN+
Inh
Exc
Exc BRAIN+ (learned
association)
Inh Exc
Campral® + CRAVING BRAIN
(learned association)
EFFECT OF Campral® ON DISRUPTED NEUROTRANSMISSION
Acutealcoholintake
Chronicexposureto alcohol
Adaptation
EAA**Excitatory Amino Acids Glutamate in particular
GABAGABA
GABA +
EAA -
EAA
Campral®
META-ANALYSIS Method of Hedges & Olkin, 1985
Included 15 randomized placebo-controlled, double-Included 15 randomized placebo-controlled, double-blind studiesblind studies
performed in 11 European countriesperformed in 11 European countries involved over 4,400 alcohol-dependent outpatientsinvolved over 4,400 alcohol-dependent outpatients
Confirmed the significant effect of acamprosate versus Confirmed the significant effect of acamprosate versus placebo on abstinence parametersplacebo on abstinence parameters
Supports the generalizability of acamprosate data Supports the generalizability of acamprosate data
CUMULATIVE ABSTINENCE DURATION PROPORTION
0
0,1
0,2
0,3
0,4
0,5
0,6
0,7
Campral
Placebo
*
*
*p < 0.05
**
**
**
*
* *
0
20
40
60
80
100
120
140
160
180
Paille et al, '95
Sass et al, '96
Whitworth et al, '96
Barrias et al, '97
Geerlings et al, '97
Pelc et al, '97
Poldrugo, '97
Chick et al, '00
Tempesta et al, '00
AcamprosatePlacebo
ACAMPROSATE EUROPEAN DOUBLE-BLIND, PLACEBO-CONTROLLED TRIALS
Days to First Drink
ACAMPROSATE EUROPEAN DOUBLE-BLIND, PLACEBO-CONTROLLED TRIALS
Rate of Total Abstinence (%)
0%
10%
20%
30%
40%
50%
60%
Lhuintre et al, '85
Pelc et al, 92
Ladewig et al, '93
Paille et al, '95
Rousseaux et al, '96
Sass et al, '96
Whitworth et al, '96
Barrias et al, '97
Geerlings et al, '97
Pelc et al, '97
Poldrugo, '97
Besson et al, '98
Chick et al, 00
Tempesta et al, '00
Gual et al. '01
Acamprosate
Placebo
Overall Mean %:
Acamprosate = 35.7%
Placebo = 21.9%
D = 13.8%
RESULTS: % ABSTAINERS IN PATIENTS ON TREATMENT
5 TRIALS (TREATMENT DURATION: 12 MONTHS)
0102030405060708090
100
0 30 90 180 270 360
acamprosate placebo%
Days
**
* **
*: p<0,001
40
50
60
70
80
90
100
0 30 90 180 270 360
Acamprosate Placebo
***
**
*: p<0,001
N = 3,338 N = 2,876 N = 958N = 2,262 N = 866N = 1,679
%
Days
ABSTINENCE RATES FOR PATIENTS WHOREMAINED IN THE TRIALS
Percentage of patients abstinent(treatment duration 3-12 months)
0
10
20
30
40
50
60
70
80
90
100
Acamprosate
Placebo
Continuous abstinence: time to first drink
% P
atie
nts
Treatment Period Follow-up Period
Never had a drink
FOLLOW-UP PERIOD(Sass et al.)
600 120 180 240 300 360 420 480 540 660600 720
EFFECT OF CAMPRAL ON ABSTINENCE RATE, CUMULATIVE ABSTINENCE
DURATION, COMPLIANCE TO TREATMENT AND CLINICAL GLOBAL IMPRESSION
0
10
20
30
40
50
60
Acamprosate Placebo
Results after 180 treatment daysPelc IBELGIUM
*
*
*
**
* p<0.05** p<0.005
Abstinence rate CAD Compliance CGI
Days
% P
atie
nts
NEW EUROPEAN ALCOHOLISM TREATMENT (NEAT) ACAMPROSATE PROGRAM
Open label, multicenter, multinational (5)Open label, multicenter, multinational (5) 1 281 alcohol-dependent patients1 281 alcohol-dependent patients 6-month study duration6-month study duration Concurrent group, individual, relapse prevention or Concurrent group, individual, relapse prevention or
brief intervention therapybrief intervention therapy Comparisons of acamprosate efficacy across therapy Comparisons of acamprosate efficacy across therapy
conditions found conditions found significant improvement in all groups in maintaining significant improvement in all groups in maintaining
abstinence and reducing relapse durationabstinence and reducing relapse duration no difference between behavioral therapy groupsno difference between behavioral therapy groups
0 50 100 150 200 250
Group therapy + CAMPRAL
Individual therapy +CAMPRAL
Cognitive therapy + CAMPRAL
Brief intervention + CAMPRAL
Total
Cumulative Abstinence Duration in daysby intervention type (per protocol)
THERE IS NO DIFFERENCE IN CAD BETWEEN DIFFERENT TYPES
OF PSYCHOTHERAPY IN PATIENTS ON Campral®
CONCLUSIONS (1)
Of all patients included
1. HRQoL in markedly reduced in alcoholic patients
2. The greater deficit is related to mental and social functioning
3. QoL at baseline is influenced by severity of alcoholism, health, employment status, age and gender
Of compliant patients
4. Treatment normalised QoL in three months
5. Abstinence and compliance are the best predictor of QoL at study end
CONCLUSIONS (2)
CAD values in the NEAT were similar to those in randomised controlled studies
Acamprosate increases QoL in enhancing abstinence.
Acamprosate
Abstinence
QOL •
Acamprosate Treatment Outcomes
FURTHER QUESTIONS
1. The Role of the Environment
2. The Role of Cognitive Functioning
3. The Time Factor
Role of Social Support - Brief Intervention and Motivational contact on the efficacy of
Acamprosate during the follow-up of detoxified alcoholic patients
Pr I. PELC and collUniversity Hospital Brugmann Université Libre de BruxellesBELGIUM
CAPRISO STUDY
Introduction (1)
Importance of "Supportive Treatment" (Social support Brief intervention-motivational Contact) in the follow-up of alcoholic patients is well documented
Studies combining pharmacotherapy and various psychosocial intervention are more seldom
Differential outcome regarding allocation of patients according to "clinical based experience" (Ansoms and coll, Belgium, 2000) or to "Patient - Treatment matching" (Project Match, USA, 1993) is not conclusive
CAPRISO STUDY
Introduction (2)
Success in implementing a "General helping process" and providing a "General well-being feeling " to the patients during follow-up, seems to be key factors throughout the various psychotherapeutic procedures during follow-up (I. Pelc, 1977 and 1985)
"Although social support has been repeatedly identified as a strong correlate of recovery from alcohol problems, enhancing social support has seldom been a focus of treatment research" (M.B. Sobell and coll., 2000)
CAPRISO STUDY
Efficacy Variables
Cumulative abstinence duration
(CAD) in per cent
Clinical Global Impression
Medication compliance
CAPRISO STUDY
Influence of baseline variables on CAD %
34
60
3541
0
20
40
60
Female Male
Fu
No Fu
5853 49
30
0
20
40
60
25-45 years 49-55 years
Fu
No Fu
%
Age
Gender
p = 0.21 (interaction test)
p = 0.33 (interaction test)
CAPRISO STUDY
Influence of baseline variables on CAD %%
Marital status
Education
5462
33
65
0
20
40
60
Nonmarried
Married
Fu
No Fu
4958 58
2833
67
0
20
40
60
None Secondary University
Fu
No Fu
%
p = 0.09 (interaction test)
p = 0.20 (interaction test)
CAPRISO STUDY
Influence of baseline variables on CAD %
3529
52
19
3734
37
53
72
45
0
20
40
60
Work Sick Disability Jobless Retired
Fu
No Fu
%
Employmentstatus
p = ns (interaction test)
CAPRISO STUDY
30
525655
0
20
40
60
FH + FH -
Fu
No Fu
%
Family history
p = 0.14 (interaction test)
51
65
4135
0
20
40
60
No SHG SHG
Fu
No Fu
Influence of baseline variables on CAD % Cont’d
p = 0.008 (interaction test)
Attendance to Self Help Group
CAPRISO STUDY
Structural modelling representation of regression analysis on CAD
Education
Marital status
F.U.
Female
SHG +
CAD
0.12
0.19
0.29
-0.24
-0.22
Regression analysis: R2 = .49
CAPRISO STUDY
30
40
50
60
70
80
90
100
V1 V2 V3 V4 V5 V6 V7 V8
No Fu
Fu
Medication Compliance
*: P<0.01
*
%
visit
CAPRISO STUDY
Rate of Complete Abstinence throughout a 6 month Period Evaluation after Detoxification
CAPRISO STUDY
RandomizedPlacebo-controlled
Study *
RandomizedPsycho-social follow-up
Study **
N = 104 N = 100
* Acamprosate in the treatment of alcohol dependence: a 6 months post-detoxification study - I. Pelc and coll, 1992
* * Capriso Study I. Pelc and coll, 2001
Placebo Acamprosate
4% 24%
Acamprosate
No Fu Fu
14% 32%
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