Club Médical Interhospitalier du Hainaut Symposium 2002 « L utilisation clinique du CAMPRAL » Prof. I. Pelc CHU Brugmann - ULB Bruxelles - Belgique

MENTAL HEALTH CHARACTERISTICS bio psycho social aspects

ACAMPROSATE Acetyl homotaurinate de calcium CH 3 -CO-NH-CH 2 -CH 2 -CH 2 -SO 3 Ca

CAMPRAL ® : A MAJOR ADVANCE IN THE TREATMENT OF ALCOHOL DEPENDENCE The first drug specifically developed to work at a neurobiological level in the mechanisms of alcohol dependence A non-aversive, CNS-acting agent Offers positive help in maintaining abstinence after alcohol withdrawal when used in conjunction with psychotherapy and social support

Campral ® : A NOVEL ACTION IN ALCOHOL DEPENDENCE NORMAL CHRONIC ALCOHOLISM BALANCE WITHDRAWALCRAVING HYPER EXCITATION BALANCE Inh Exc Inh Exc BARAlc + Exc BRAIN + BAR Alc Inh Exc BRAIN + Inh Exc BRAIN + (learned association) InhExc Campral® + CRAVING BRAIN (learned association)

META-ANALYSIS Method of Hedges & Olkin, 1985 uIncluded 15 randomized placebo-controlled, double- blind studies l performed in 11 European countries l involved over 4,400 alcohol-dependent outpatients uConfirmed the significant effect of acamprosate versus placebo on abstinence parameters uSupports the generalizability of acamprosate data

STUDY SIZE

CUMULATIVE ABSTINENCE DURATION PROPORTION * * *p < 0.05 * * * * * * * * *

ACAMPROSATE EUROPEAN DOUBLE- BLIND, PLACEBO-CONTROLLED TRIALS Days to First Drink

ACAMPROSATE EUROPEAN DOUBLE-BLIND, PLACEBO-CONTROLLED TRIALS Rate of Total Abstinence (%) Overall Mean %: Acamprosate = 35.7% Placebo = 21.9% D = 13.8%

* * * * * *: p<0,001 N = 3,338 N = 2,876 N = 958 N = 2,262 N = 866 N = 1,679 % Days ABSTINENCE RATES FOR PATIENTS WHO REMAINED IN THE TRIALS Percentage of patients abstinent (treatment duration 3-12 months)

Acamprosate Placebo Continuous abstinence: time to first drink % Patients Treatment PeriodFollow-up Period Never had a drink FOLLOW-UP PERIOD (Sass et al.)

EFFECT OF CAMPRAL ON ABSTINENCE RATE, CUMULATIVE ABSTINENCE DURATION, COMPLIANCE TO TREATMENT AND CLINICAL GLOBAL IMPRESSION Results after 180 treatment days Pelc I BELGIUM * * * ** * p<0.05 ** p<0.005 Abstinence rateCADComplianceCGI Days % Patients

Cumulative Abstinence Duration in days by intervention type (per protocol) THERE IS NO DIFFERENCE IN CAD BETWEEN DIFFERENT TYPES OF PSYCHOTHERAPY IN PATIENTS ON Campral ®

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 = never1 = seldom 2 = sometimes3 = frequently according 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 = never1 = seldom 2 = sometimes3 = frequently according 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 = never1 = seldom 2 = sometimes3 = frequently according 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 time and interrater reliability: 0 = never2 = sometimes 1 = seldom3 = frequently

CONCLUSIONS CAD values in the NEAT were similar to those in randomised controlled studies Acamprosate increases QoL in enhancing abstinence. Acamprosate Treatment Outcomes Acamprosate AbstinenceQOL

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 coll University Hospital Brugmann Université Libre de Bruxelles BELGIUM CAPRISO STUDY

Efficacy Variables u Cumulative abstinence duration (CAD) in per cent u Clinical Global Impression u Medication compliance CAPRISO STUDY

Cumulative abstinence days (%) p < 0.23 CAPRISO STUDY

Influence of baseline variables on CAD % Contd p = (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 Regression analysis: R 2 =.49 CAPRISO STUDY

Rate of Complete Abstinence throughout a 6 month Period Evaluation after Detoxification CAPRISO STUDY Randomized Placebo-controlled Study * Randomized Psycho-social follow-up Study ** N = 104N = 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%