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P.6.a.012 Trazodone treatment in the sleep disturbances of alcohol-dependent patients after detoxification
P.6.a Addiction – Alcohol (clinical) related with the admission, a shorter length of stay was observed (16.1±1.59 days vs. 26.41±2.95 days, p < 0.005). Conclusions: – Our data show that dual diagnosis is a common clinical problem in patients with AUD. – A higher prevalence of personality disorders and depressive disorders (referring to nonSUD-PD) and nicotine, cocaine, sedative and cannabis use disorders (referring to SUD) was observed in AUD sample. References [1] Fein G et al, 2007, Sub-diagnostic psychiatric comorbidity in alcoholics. Drug Alcohol Depend 87, 139–145. [2] Spanish National Report, 2005, Spanish Drug Observatory (OED). Government Delegation for the National Plan on Drugs (DGPND). [3] European Monitoring Centre for Drugs and Drug Addiction, year Annual report 2006: the state of the drugs problem in Europe.
P.6.a.012 Trazodone treatment in the sleep disturbances of alcohol-dependent patients after detoxification A. Ciobanu1 ° , A. Dragan2 , A. Danciu3 . 1 Psychiatric Hospital “Al Obregia”, 9-th Department, Bucharest, Romania; 2 Individual Medical Cabinet, Psychiatry, Bucharest, Romania; 3 Constantin and Elena Hospital, Psychiatry, Ilfov, Romania Objectives: Some evidence indicates that the trazodone may be effective in maintain abstinence in alcohol-dependent patients and can improve the sleep disturbances. The primary objective of this study was to evaluate cumulative abstinence duration (CAD) who was defined as the totaled number of abstinent days recorded on all diary cards for the period between first day of study and end of medication. The second objective was to evaluate the correlation between the quality of sleep and the alcohol relapse. Methods: 150 patient, 18–65 years, 112 men, diagnosed by DSM IV criteria with alcohol dependence and sleep disturbances (associated /no with depression) completed the treatment standard of alcohol detoxification. After detoxification the patients were divided in 2 groups: group A with 82 patients with depressive episode who associated sleep disturbance and group B with 68 patients only with sleep disturbance. Group A was subdivided in subgroup A1: 52 patients at first depressive episode and subgroup A2: 30 patients at recurrent depressive episode. The dose of trazodone was flexible between 150–300 mg/ day for 6 month of study. During the 6 month, with visit at every 3 month, it was evaluate efficacy of trazodone in group A versus efficacy in group B, and subgroup A1 versus subgroup A2. We use the following efficacy variables: Questionnaire for sleep improvement, cumulative abstinence duration (CAD), time to first relapse, continuous abstinence rates. Exclusion criteria: receiving disulfiram, abused drugs, serious medical or psychiatric disorders, pregnancy. Results: The correlation between quality of sleep and relapse: All compliance patients described a good/very good improvement of quality of sleep after 3 month of treatment with trazodone. At the end of the study all compliance patients who take trazodone were abstinent and they don’t have relapsed. At more than 70% patients who were noncompliance we found relapse, and at 20% we found relapse with hospitalization. The time to first relapse: The mean time of abstinence prior to the first relapse was longer in subgroup A1 (156 days) than subgroup A2 (84 days).
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Continuous abstinence: More patients on group B (46%) remained continuously abstinent during the 6 month of treatment, than patients on group A (25%) CAD. The mean duration of abstinence was 145 days on group B and 128 days on group A. The number of relapses with hospitalization was more in subgroup A2 (n = 8). The most relapses were associated with four high-risk situations: panic disorder, frustration and anger, social problems, interpersonal temptation. The treatment was well tolerated during the period of study. Somnolence was reported in some case at begin of the study but after 2 weeks of treatment that adverse event disappear. Conclusions: 1. The results of this investigation demonstrate the efficacy of trazodone in treatment of sleep disturbance at patients with/without depression. 2. The most important results were reported at patients who received trazodone and diagnosed only with sleep disturbance who not associated depression. 3. The results were better at subgroup A1 than subgroup A2. References [1] Barrick C, Connors GJ, 2003, Relapse prevention and maintaining abstinence in older adults with alcohol use disorders. Drugs Aging 19, 583–594. [2] Hunt WA, Barnett LW, Branch LG, 1971, Relapse rates in addictions programs. J Clin Psychol 27, 455–456. [3] Polisch JM, Armor DJ, Braiker HB, 1981, Stability and change in drinking patterns. In: The Course of Alcoholism: Four Years After Treatment. New York: John Wiley & Sons, pp. 159–200.
P.6.a.013 Efficacy and tolerability of quetiapine, combined with naltrexone, in the treatment of alcohol dependence J. Guardia1 , C. Roncero2 , J.L. Galan3 ° , C. Barcons4 , M. Casas5 . 1 Hospital de la Santa Creu i Sant Pau, Unidada de Conductas Adictivas, Barcelona, Spain; 2 Hospital Universitario Vall d’Hebron. Universidad Autonoma de Barcelona., Psiquitria., Barcelona, Spain; 3 AstraZeneca Farmaceutica Spain, cns, Madrid, Spain; 4 Hospital Universitario Vall d’Hebron, Psiquiatria, Barcelona, Spain; 5 Hospital Universitario Vall d’Hebron. Universidad Autonoma de Barcelona., Psiquiatria, Barcelona, Spain Objective: The purpose of this study was to assess the efficacy and tolerability of quetiapine combined with naltrexone (opioid antogonist with anticraving effect approved for alcoholism) in the treatment of alcohol dependence. Method: This was a 12-week, randomized, double-blind, placebo-controlled, parallel study with quetiapine or placebo, combined with naltrexone. After detoxification patients received naltrexone (50 mg/day) for 1 week. Subsequently, patients were randomized to quetiapine 25 mg/day or placebo. The dose of quetiapine was increased by 25 mg/day per week until a dose of 200 mg/day was reached at week 8 following which patients received this dose for a further 3 weeks. After 11 weeks, quetiapine or placebo were reduced progressively until being stopped at week 12. The patients received treatment with naltrexone for 4 more weeks. The primary outcome measure was percentage of days that the patient had alcohol drinks, amount of alcohol drinks taken each time and relapse rate. Secondary objectives evaluated the levels of craving with the Visual Analogue Scale and Obsessive
P.6.a.012 Trazodone treatment in the sleep disturbances of alcohol-dependent patients after detoxification A. Ciobanu1 ° , A. Dragan2 , A. Danciu3 . 1 Psychiatric Hospital “Al Obregia”, 9-th Department, Bucharest, Romania; 2 Individual Medical Cabinet, Psychiatry, Bucharest, Romania; 3 Constantin and Elena Hospital, Psychiatry, Ilfov, Romania Objectives: Some evidence indicates that the trazodone may be effective in maintain abstinence in alcohol-dependent patients and can improve the sleep disturbances. The primary objective of this study was to evaluate cumulative abstinence duration (CAD) who was defined as the totaled number of abstinent days recorded on all diary cards for the period between first day of study and end of medication. The second objective was to evaluate the correlation between the quality of sleep and the alcohol relapse. Methods: 150 patient, 18–65 years, 112 men, diagnosed by DSM IV criteria with alcohol dependence and sleep disturbances (associated /no with depression) completed the treatment standard of alcohol detoxification. After detoxification the patients were divided in 2 groups: group A with 82 patients with depressive episode who associated sleep disturbance and group B with 68 patients only with sleep disturbance. Group A was subdivided in subgroup A1: 52 patients at first depressive episode and subgroup A2: 30 patients at recurrent depressive episode. The dose of trazodone was flexible between 150–300 mg/ day for 6 month of study. During the 6 month, with visit at every 3 month, it was evaluate efficacy of trazodone in group A versus efficacy in group B, and subgroup A1 versus subgroup A2. We use the following efficacy variables: Questionnaire for sleep improvement, cumulative abstinence duration (CAD), time to first relapse, continuous abstinence rates. Exclusion criteria: receiving disulfiram, abused drugs, serious medical or psychiatric disorders, pregnancy. Results: The correlation between quality of sleep and relapse: All compliance patients described a good/very good improvement of quality of sleep after 3 month of treatment with trazodone. At the end of the study all compliance patients who take trazodone were abstinent and they don’t have relapsed. At more than 70% patients who were noncompliance we found relapse, and at 20% we found relapse with hospitalization. The time to first relapse: The mean time of abstinence prior to the first relapse was longer in subgroup A1 (156 days) than subgroup A2 (84 days).
S545
Continuous abstinence: More patients on group B (46%) remained continuously abstinent during the 6 month of treatment, than patients on group A (25%) CAD. The mean duration of abstinence was 145 days on group B and 128 days on group A. The number of relapses with hospitalization was more in subgroup A2 (n = 8). The most relapses were associated with four high-risk situations: panic disorder, frustration and anger, social problems, interpersonal temptation. The treatment was well tolerated during the period of study. Somnolence was reported in some case at begin of the study but after 2 weeks of treatment that adverse event disappear. Conclusions: 1. The results of this investigation demonstrate the efficacy of trazodone in treatment of sleep disturbance at patients with/without depression. 2. The most important results were reported at patients who received trazodone and diagnosed only with sleep disturbance who not associated depression. 3. The results were better at subgroup A1 than subgroup A2. References [1] Barrick C, Connors GJ, 2003, Relapse prevention and maintaining abstinence in older adults with alcohol use disorders. Drugs Aging 19, 583–594. [2] Hunt WA, Barnett LW, Branch LG, 1971, Relapse rates in addictions programs. J Clin Psychol 27, 455–456. [3] Polisch JM, Armor DJ, Braiker HB, 1981, Stability and change in drinking patterns. In: The Course of Alcoholism: Four Years After Treatment. New York: John Wiley & Sons, pp. 159–200.
P.6.a.013 Efficacy and tolerability of quetiapine, combined with naltrexone, in the treatment of alcohol dependence J. Guardia1 , C. Roncero2 , J.L. Galan3 ° , C. Barcons4 , M. Casas5 . 1 Hospital de la Santa Creu i Sant Pau, Unidada de Conductas Adictivas, Barcelona, Spain; 2 Hospital Universitario Vall d’Hebron. Universidad Autonoma de Barcelona., Psiquitria., Barcelona, Spain; 3 AstraZeneca Farmaceutica Spain, cns, Madrid, Spain; 4 Hospital Universitario Vall d’Hebron, Psiquiatria, Barcelona, Spain; 5 Hospital Universitario Vall d’Hebron. Universidad Autonoma de Barcelona., Psiquiatria, Barcelona, Spain Objective: The purpose of this study was to assess the efficacy and tolerability of quetiapine combined with naltrexone (opioid antogonist with anticraving effect approved for alcoholism) in the treatment of alcohol dependence. Method: This was a 12-week, randomized, double-blind, placebo-controlled, parallel study with quetiapine or placebo, combined with naltrexone. After detoxification patients received naltrexone (50 mg/day) for 1 week. Subsequently, patients were randomized to quetiapine 25 mg/day or placebo. The dose of quetiapine was increased by 25 mg/day per week until a dose of 200 mg/day was reached at week 8 following which patients received this dose for a further 3 weeks. After 11 weeks, quetiapine or placebo were reduced progressively until being stopped at week 12. The patients received treatment with naltrexone for 4 more weeks. The primary outcome measure was percentage of days that the patient had alcohol drinks, amount of alcohol drinks taken each time and relapse rate. Secondary objectives evaluated the levels of craving with the Visual Analogue Scale and Obsessive