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| |  Quetiapine Combined With Naltrexone Does Not Enhance Efficacy for Treatment of Alcohol Dependence: Presented at ECNP By Paula Moyer VIENNA, AUSTRIA -- October 23, 2007 -- Patients do not receive any additional efficacy benefits when they receive quetiapine in addition to naltrexone for the treatment of alcohol dependence, according to investigators who presented their findings here at the 20th European College of Neuropsychopharmacology (ECNP) Congress. In a study in which patients were randomised to naltrexone and either quetiapine or placebo, both groups improved similarly in terms of alcohol-free days, amount of alcohol taken each time, and relapse rate, said principal investigator José Garcia, MD, Consulting Psychiatrist, Hospital de la Santa Creu i Sant Pau, Unidada de Conductas Adictivas, Barcelona, Spain. "The addition of quetiapine did not demonstrate any efficacy advantage over naltrexone alone," he said in a presentation October 14. Dr. Garcia and his coinvestigators wanted to assess the efficacy and tolerability of quetiapine combined with naltrexone in the treatment of alcohol dependence because earlier research had shown that adding atypical antipsychotics to naltrexone in certain cases could reduce hospitalisations, reduce relapses, and improve sleep quality. Therefore, they conducted a 12-week, randomised, double-blind, placebo-controlled, parallel study. The 62 patients received either quetiapine or placebo combined with naltrexone. After the patients had completed detoxification, they received 50 mg/day of naltrexone for 1 week, and then either 25 mg/day of quetiapine or placebo. The patients' dose of quetiapine was increased by 25 mg/day per week until they were receiving a dose of 200 mg/day at week 8. Those in the quetiapine arm received this dose for an additional 3 weeks. After the week 11, the patients' doses of quetiapine or placebo were reduced progressively until they were stopped at week 12; however, the naltrexone dose continued for 4 more weeks. The investigators monitored patients for percentage of days that the patient had alcohol drinks, the volume of alcohol taken at each drinking episode, and the relapse rate. They also wanted to gauge the levels of craving with the Visual Analogue Scale and Obsessive Compulsive Drinking Scale (OCDS), as well as the retention rate in the treatment program, which was measured by the number of visits and measurements for searching substances in urine/alcohol tests. They also assessed the use of other substances, the level of treatment compliance, the occurrence of withdrawal, and the rate of adverse events. Additionally, the investigators assessed patients' psychiatric symptoms with the Hopkins Symptom Checklist-90, the Addiction Severity Index, the State-Trait Anger Expression Inventory, the State-Trait Anxiety Inventory, the University of Rhode Island Change Assessment, and the Beck Depression Inventory, as well as the Global Assessment of Functioning and Clinical Global Impression scales. Among these patients, 30 patients were in the quetiapine group and 32 were in the placebo group; 79% had severe and 21% moderate levels of addiction. The baseline characteristics were similar between groups, except that patients in the quetiapine group had a higher baseline level of abuse of alcohol than the control group (P =.04). The quetiapine group also had a more severe level of abuse of alcohol than the quetiapine group as assessed by OCDS global and compulsive factors (P =.04 and P =.01, respectively). Patients in the quetiapine group received an average dose of 127.5 mg/day during the study. The quetiapine and placebo groups had similar improvements in the percentage of alcohol-free days (94% vs 98%, respectively); the amount of alcohol taken each time (1.6 vs 0.9 standard drink units, respectively); and relapse rate (61% vs 72%, respectively). Further, the psychiatric assessments were similar between groups, and treatment compliance was similar (>80% in both groups). There were 12 patient withdrawals in each group. Nine adverse events occurred in the quetiapine group and eight in the placebo group. These consisted of two events of somnolence, two of anxiety, two of restlessness, and one of decreased libido in the quetiapine group. In the placebo group, these consisted of two each of dizziness, somnolence, anxiety, and restlessness, and one each of dyspepsia and dry mouth. The study was funded by AstraZeneca PLC.
[Presentation title: Efficacy and Tolerability of Quetiapine, Combined With Naltrexone, in the Treatment of Alcohol Dependence. Abstract P.6.a.013]
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