Nalmefene, comparison between two groups: in steady and as-needed assumption

Introduction: The opioid system modulator nalmefene (NMF) is the first pharmacological therapy to be approved in the EU to reduce alcohol consumption in adults with alcohol dependence and a high drinking risk level with formulation of 18mg. die. To the best of our knowledge so far no study has been conducted to evaluate the efficacy of nalmefene, than that in the control of symptoms of dependence, in controlling anxiety, depression and general functioning symptoms. Objective: Thus, the aim of this naturalistic study was to investigate the impact of adjunctive nalmefene with different dose in two groups: group 1 in steady assumption; group 2 as-needed assumption. Also, we investigated the efficancy and safety of nalmefene on reducing anxiety, depression and general functioning sympthoms among five different times (T0; T1; T2; T3; T4). Methods: The sample consisted of admitted alcohol disorder patients (N=30), they was observed for three months; they all were drug stabilized (benzodiazepines, antipsychotics, antidepressants, anxiolytics) and they were followed with psycho-social treatment. Diagnosis was following the DSM-IV-TR criteria. This study was a pilot research that analized a part of a larger sample and the results was defined only by first statistical analisys. The patients underwent a comprehensive evaluation including self-report and clinician-report questionnaires such as the Clinical Institute Withdrawal Assessment for Alcohol (CIWA), the Hamilton Depression Rating Scale (HAM-D), the Hamilton Anxiety Rating Scale (HAM-A), the Symptoms Check-List 90 (SCL-90), the Visual Analogic Scale: Craving Scale (VAS), the Obsessive Compulsive Drinking Scale (OCDS). Results: The research found a significant difference among means for paired-samples among the various instruments used in the different times. In detail, greater difference among means for the different instruments was found: for the CIWA between time T1 and T2 (p≤0.05), for the HAM-D between time T3 and T4 (p≤0.05); for the HAM-A between time T1 and T2 (p≤0.05); for the VAS between time T2 and T3 (p≤0.05); for the GAF between time T2 and T3 (p≤0.05) for the BPRS between time T1 and T2 (p≤0.05); for the OCDS between time T1 and T2 (p≤0.05). The data was referring a difference between two groups but this one was not significant. Conclusions: The first results would confirmed a general reduction trend of the symptoms from the beginning of nalmefene treatment assessed by our instruments. The improvement peak occurs within seven days of taking the drug, with the exception of depressive symptoms, which tend to most improve between fifteen and thirty days. The drug could seem a better efficacy into as-needed group, but these data will be verified. Given the naturalistic setting of the study, future of our research aims will be to investigate efficacy and tolerability therapeutic of Nalmefene in controlled study with larger sample sizes.