Gender Differences and Psychopathological Features Associated With Addictive Behaviors in Adolescents.

BACKGROUND: The aims of the study were to assess prevalence and gender differences of addictive behaviors (substance- and non-substance-related) in an adolescent population, and their association with psychopathological features and academic performance. MATERIAL AND METHODS: A sample of high school Italian students (n = 996; M = 240, F = 756) was examined using a self-report survey concerning sociodemographic characteristics, cigarette smoking, alcohol and substance use, perceived academic performance, activities, and behaviors (Internet use, gambling, and physical exercising). The Internet Addiction Test, the South Oaks Gambling Screen-revised Adolescent, and the Exercise Addiction Inventory-Short Form were administered to identify problematic behaviors. The Barratt Impulsiveness Scale for Adolescent, the Snaith-Hamilton Pleasure Scale, the Dissociative Experience Scale for Adolescent, and the Toronto Alexithymia Scale were used to investigate psychopathological dimensions. RESULTS: Frequent alcohol intake and lifetime substances consumption were more common among males. The occurrence of other addictive behaviors was 22.1% for problematic Internet use (M = F), 9.7% for at-risk/problematic gambling (M > F), and 6.2% for maladaptive physical exercise (M = F). We also found an association between substance-/non-substance-related addictive behaviors and psychopathological dimensions. Addictive behaviors were more frequent among students reporting poor school performance. CONCLUSION: Our study showed a relevant prevalence of addictive behaviors in a sample of Italian high school students, with specific gender differences. We underlined the cooccurrence of substance and non-substance-related addictive behaviors, and their association with worse school performance. Dissociative proneness, anhedonia, alexithymia, and impulsivity were associated with addictive behaviors in adolescents and might represent vulnerability factors for the development of psychiatric disorders in adulthood. A better understanding of psychopathological features associated with addictive behaviors might be useful for the prevention/early intervention.

Coping strategies in a sample of anxiety patients: factorial analysis and associations with psychopathology.

BACKGROUND: The relationship between coping styles and mental disorders has received considerable attention and instruments have been developed to assess coping strategies. The measurement by means of category systems has been criticized and a functional hierarchy of action types linked to the adaptive processes is preferred. We aimed to determine which factors may exist within the Brief-COPE (Brief Coping Orientation to Problems Experienced--COPE--Inventory) in an Italian sample of patients with anxiety disorders; and if these factors correlate with the severity of psychopathology or with other characteristics. METHODS: A total sample of 148 patients was recruited. The Brief-COPE inventory, the Symptom Check List 90-Revised, the Penn State Worry Questionnaire, the Zung Anxiety Status Inventory and the Zung Self-Rating Anxiety Scale were administered. RESULTS: Factor analysis of the Brief-COPE yielded nine factors accounting for 65.48% of the variance. Patients scored higher on Searching Support, followed by Acceptance, Changing Perspective, and Problem Solving. Associations between measures of psychopathology and factors of coping strategies, mostly Searching support and Avoidance, were found. CONCLUSIONS: Data of the present study support a nine-factor structure of the Brief-COPE that includes five broad dimensions of coping. Psychopathology was mostly related to Searching support and Avoidance factors, showing that these strategies may reflect ineffective ways of coping; Problem solving and Changing perspective could be a valid approach to moderate anxiety/depression symptoms and psychopathology in general.

Co-occurrence of alcohol use disorder and behavioral addictions: relevance of impulsivity and craving.

PURPOSE: The aims of the study were to evaluate the occurrence of behavioral addictions (BAs) in alcohol use disorder (AUD) subjects and to investigate the role of impulsivity, personality dimensions and craving. METHODS: 95 AUD outpatients (DSM-5) and 140 homogeneous controls were assessed with diagnostic criteria and specific tests for gambling disorder, compulsive buying, sexual, internet and physical exercise addictions, as well as with the Barratt Impulsiveness Scale (BIS-11) and Temperamental and Character Inventory-Revised (TCI-R). The Obsessive Compulsive Drinking Scale (OCDS) and Visual Analogue Scale for craving (VASc) were also administered to the AUD sample. RESULTS: 28.4% (n=27) of AUD subjects had at least one BA, as compared to 15% (n=21) of controls (χ(2)=6.27; p=.014). In AUD subjects, direct correlations between BIS-11 and Compulsive Buying Scale (CBS), Internet Addiction Disorder test (IAD), Exercise Addiction Inventory-Short Form (EAI-SF) scores (p<.01), between OCDS obsessive and CBS and VASc and CBS, IAD scores (p<.003), were found. BIS-11 (t=-2.36; p=.020), OCDS obsessive (Z=-4.13; p<.001), OCDS compulsive (Z=-2.12; p=.034) and VASc (Z=-4.94; p<.001) scores were higher in AUD subjects with co-occurring BAs. The occurrence of BAs was associated with higher impulsivity traits (BIS-11 scores; OR=1.08; p=.012) and higher craving levels (VASc scores; OR=2.48; p<.001). CONCLUSIONS: Our findings emphasize a significant rate of co-occurrence of BAs in AUD. High levels of impulsivity and craving for alcohol seem to be associated with other addictive behaviors.

Adult attention-deficit/hyperactivity disorder in major depressed and bipolar subjects: role of personality traits and clinical implications.

A significant comorbidity between attention-deficit/hyperactivity disorder (ADHD) and affective disorders has been consistently reported in adults. Less data regarding the role of personality traits and the influence of ADHD co-occurrence on clinical characteristics and outcome of mood disorders are currently available. One hundred and six remitted major depressed, 102 euthymic bipolar subjects, and 120 healthy controls, homogeneous with respect to demographic characteristics, were included in the study. ADHD diagnosis was based on DSM-IV-TR criteria. Childhood and adult ADHD features were measured with the Wender Utah Rating Scale, the Adult ADHD Self-rating Scale, and the Brown Attention-Deficit Disorder Scale. The Revised NEO Personality Inventory was also administered to the clinical groups, in order to investigate personality dimensions. The occurrence of adult ADHD in subjects with bipolar disorders (BD) or major depressive disorder (MDD) was 15.7 and 7.5 %, respectively, compared to 3.3 % in healthy controls (HC). Significant associations (p < .001) between personality traits (neuroticism, conscientiousness, and extraversion) and ADHD features were observed. Logistic regression analysis of all clinical subjects (n = 208) showed that those with lower levels of neuroticism (OR = 1.031; p = .025) had a lower frequency of ADHD comorbidity. The present study emphasizes the close relationship between affective disorders, especially BD, and ADHD in adults. Our findings support the need to assess subjects with mood disorders in the clinical setting for possible coexisting ADHD and to further investigate personality traits to better understand the etiology of affective disorders and ADHD co-occurrence.

Craving Typology Questionnaire (CTQ): a scale for alcohol craving in normal controls and alcoholics.

INTRODUCTION: Craving is commonly thought to play a crucial role both in the transition from controlled drinking to alcohol dependence and in the mechanism underlying relapse. However there is no consensus on its definition, and on its correct assessment. Another significant hindrance is that craving is almost certainly a multi-faceted construct. To this respect a three pathway psychobiological model able to differentiate craving into a reward, relief, and obsessive component has been suggested. METHODS: CTQ was administered to 547 control subjects and to 100 alcohol dependent patients. The dimensional structure of the questionnaire, through the principal component analysis, the reliability and the threshold values were evaluated in both the control and clinical sample. RESULTS: The results showed and confirmed that the CTQ is composed of three dimensions. Cronbach's alpha coefficients suggest that the questionnaire is reliable. Alcohol-dependent subjects had a significantly higher mean score as compared to the normative sample in both Reward, Relief, Obsessive craving. Younger age correlated with higher scores on Reward craving (r=0.38; p<0.001) and males reported significantly higher scores than women on Reward craving (t=4.36; p<0.001). DISCUSSION: CTQ showed to be a reliable and valid questionnaire to distinguish a normative sample from pathological individuals. The average scores obtained represent the first normative data available for this questionnaire. Identifying a craving type may represent an important predicting or matching variable for anti-craving psychotropics. More research is needed with respect to CTQ's external validity, i.e. correlations with phenotypic, endophenotypic and genetic indicators of relief, reward and obsessive drinking.

Reduced hedonic capacity in euthymic bipolar subjects: a trait-like feature?

BACKGROUND: The aim of our study was to assess hedonic capacity in euthymic bipolar subjects, identifying possible differences compared to remitted unipolar depressed patients and healthy controls. METHODS: 107 subjects with bipolar disorders, 86 with major depressive disorder and 106 healthy controls, homogeneous with respect to demographic characteristics, were enrolled. The following scales were administered: the Snaith-Hamilton pleasure scale (SHAPS), the subscale for 'anhedonia/asociality' of the scale for the assessment of negative symptoms (SANS) and the visual analogue scale (VAS) for hedonic capacity. RESULTS: Scores on SHAPS total, interests and social interactions, SANS 'anhedonia/asociality' and VAS were all significantly higher in affective disorder patients compared to healthy controls. No difference was found between clinical groups. 20.5% (n=22) of bipolar disorder subjects and 24.5% (n=21) of major depressed subjects showed a significant reduction in hedonic capacity (SHAPS total score ≥ 3), compared to 7.5% (n=8) of healthy controls (χ(2)=12.03; p=.002). LIMITATIONS: Limitations include heterogeneity with respect to pharmacological status and longitudinal course (i.e., 'single' vs. 'recurrent' affective episodes). CONCLUSIONS: The major finding of our study is that euthymic bipolar patients and remitted major depressed patients display residual anhedonic symptoms. This suggests that, in affective disorder patients, altered hedonic capacity could represent an enduring trait and that, possibly, dysfunctions in the neurobiological mechanisms underlying hedonic response and reward processing persist, irrespective of mood state.

Role of substance abuse comorbidity and personality on the outcome of depression in bipolar disorder: harm avoidance influences medium-term treatment outcome.

Comorbid conditions are frequent in bipolar disorder (BD) and may complicate the treatment and course of illness. We investigated the role of substance use disorder (SUD), axis II personality disorders (PD) and continuous personality traits on the medium-term outcome (6 months) of treatment for bipolar depression. One hundred and thirty-nine BD patients meeting criteria for a depressive episode were included in the study. SUD and PD were diagnosed according to structured interviews. Personality dimensions were evaluated by the Temperament and Character Inventory. Depressive severity over time was evaluated by the Hamilton Rating Scale for Depression. Neither PD nor SUD influenced the outcome of depression. Variables independently associated with a poor outcome were a high baseline severity and high scores for the temperamental trait of Harm Avoidance. Though several limitations characterize the present study, neurotic personality traits seem to be associated with a slower recovery from depressive symptoms in BD, independently from their initial severity.

Bipolar disorder: "pure" versus mixed depression over a 1-year follow-up.

OBJECTIVES: To compare two samples of Bipolar (BD) patients presenting "pure" (D) and mixed (Mx) depression to assess any difference in terms of clinical outcome, social functioning and quality of life during a 1-year follow-up. METHODS: A total of 114 depressed outpatients (HDRS > 13) were included. "Pure" depressed (D, n = 76) were divided from "mixed" depressed (Mx, n = 38) by the number of concomitant manic symptoms. All patients were evaluated by the Hamilton Depression Rating Scale (HDRS), the Hamilton Anxiety Rating Scale (HARS), the Young Mania Rating Scale (YMRS), the Global Assessment of Functioning (GAF), the Social Adjustment Self-reported Scale (SASS) and the Quality of Life Scale (QoL), at baseline and after 1, 3, 6 and 12 months of treatment. RESULTS: Mx patients were significantly younger at the onset of BD. Manic features persisted significantly higher in Mx than in D patients all over the follow-up period. Axis I comorbidities had a negative impact on the course of social functioning over the medium term period, while Mx patients showed a faster improvement in social adjustment than "pure" depressed patients. CONCLUSIONS: Mixed features may persist relatively stable throughout a depressive episode, having a negative impact over clinical and functional outcome, but not on social adjustment.

Factors associated with the course of symptoms in bipolar disorder during a 1-year follow-up: depression vs. sub-threshold mixed state.

BACKGROUND: Mixed mood states, even in their sub-threshold forms, may significantly affect the course and outcome of bipolar disorder (BD). AIM: To compare two samples of BD patients presenting a major depressive episode and a sub-threshold mixed state in terms of global functioning, clinical outcome, social adjustment and quality of life during a 1-year follow-up. METHODS: The sample was composed by 90 subjects (Group 1, D) clinically diagnosed with a major depressive episode and 41 patients (Group 2, Mx) for a sub-threshold mixed state. All patients were administered with a pharmacological treatment and evaluated for depressive, anxious and manic symptoms by common rating scales. Further evaluations included a global assessment of severity and functioning, social adjustment and quality of life. All evaluations were performed at baseline and after 1, 3, 6 and 12 months of treatment. RESULTS: The two groups were no different for baseline as well as improvement in global severity and functioning. Though clearly different for symptoms severity, the amount of change of depressive and anxiety symptoms was also no different. Manic symptoms showed instead a trend to persist over time in group 2, whereas a slight increase of manic symptoms was observed in group 1, especially after 6 months of treatment. Moreover, in group 1, some manic symptoms were also detected at the Young Mania Rating Scale (n = 24, 26.6%). Finally, improvement in quality of life and social adjustment was similar in the two groups, though a small trend toward a faster improvement in social adjustment in group 1. CONCLUSIONS: Sub-threshold mixed states have a substantial impact on global functioning, social adjustment and subjective well-being, similarly to that of acute phases, or at least major depression. In particular, mixed features, even in their sub-threshold forms, tend to be persistent over time. Finally, manic symptoms may be still often underestimated in depressive episodes, even in patients for BD.

Prevalence and intensity of basic symptoms among cannabis users: an observational study.

BACKGROUND: It is difficult to establish whether people who are prone to psychosis are drawn to cannabis use or whether cannabis use truly increases the incidence of psychotic experiences. OBJECTIVES: The aim of our study was to evaluate, in a sample of healthy high school and university students, the presence and level of subjective experiences (SEs) and their relation to cannabis use. METHODS: A total of 502 voluntary subjects were recruited; an anamnestic interview was administered to obtain socio-demographic information, cannabis use data, and psychiatric familial history. SEs were assessed using the Italian version of the Frankfurt Complaint Questionnaire (FCQ). RESULTS: One hundred and fourteen subjects declared the use of cannabis: 20.5% smoked more than 1 joint per week, and 71.9% used cannabis for a period of more than 1 year. Cannabis users did not differ from the cannabis-free group in any of the 10 FCQ dimensions. Higher FCQ total scores were found in cannabis users with a familial history of psychiatric disorders respective to those without a psychiatric load (p<.05). CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: In our study, SE intensity was not influenced by the use of cannabis. With regard to familial data, this is the first study to explore the relationship between SE and the presence of psychiatric problems in first-degree relatives. The association between FCQ intensity and psychiatric familial load may confirm the independence of these phenomena from the use of cannabis.

Acetyl-l-Carnitine in the treatment of anhedonia, melancholic and negative symptoms in alcohol dependent subjects.

OBJECTIVE: Aim of this randomized, double-blind, placebo-controlled study was to evaluate the efficacy of Acetyl-l-Carnitine (ALC), at different dosages, on specific anhedonic symptoms in detoxified alcohol dependent subjects. Secondary endpoints were the effect of ALC on melancholic and negative symptoms. METHOD: Sixty-four anhedonic alcohol dependent patients with minor or absent withdrawal symptoms were randomized: 23 received ALC at a dosage of 3g/day, 21 received ALC at a dosage of 1g/day, and 20 were given placebo. ALC was given intravenously for 10days, followed by 80days of oral treatment plus a follow-up period of 45days. The presence of anhedonic symptoms was determined by the SHAPS (Snaith-Hamilton Pleasure Scale) and the VASa (Visual Analogue Scale for Anhedonia); negative and melancholic symptoms were evaluated by the SANS (Scale for the Assessment of Negative Symptoms), and the BRMS (Bech-Rafaelsen Melancholia Scale). RESULTS: The natural course of anhedonia in the placebo group showed a decline until day 30 and remains stable for the rest of the study. Intravenously ALC accelerated the improvement of anhedonia reaching constant low levels early, on day 10. At this step levels of anhedonia (SHAPS, VASa) and melancholic symptoms (BRMES) resulted significantly reduced (p<0.05) in both the ALC 3g and ALC 1g groups with respect to placebo; SANS scores significantly reduced only in the ALC 1g respect to placebo (p=0.014). During oral treatment with ALC, anhedonia scores did not differ from placebo. CONCLUSION: Intravenously ALC was effective in accelerating the abstinence-associated improvement of anhedonia, melancholic and negative symptoms, whereas oral ALC treatment starting on day 10 showed no further improvements. Accordingly, in alcohol dependent subjects, ALC may be considered as a new potentially useful drug for the treatment of anhedonia.

Acetyl-L-carnitine for alcohol craving and relapse prevention in anhedonic alcoholics: a randomized, double-blind, placebo-controlled pilot trial.

AIM: The study aimed to evaluate the efficacy of acetyl-l-carnitine (ALC), at different doses, in relapse prevention and craving in anhedonic detoxified alcohol-dependent subjects. METHOD: Randomized, double-blind, placebo-controlled, pilot study in 64 alcohol-dependent anhedonic patients: 23 received ALC at a dose of 3 g/day, 21 received ALC at a dosage of 1 g/day and 20 were given placebo. Intensity of alcohol craving was evaluated by Visual Analogue Scale. Subjects were evaluated at the beginning of treatment and after 10, 30, 60 and 90 days. RESULTS: Survival analysis showed that patients treated with ALC remained completely abstinent for longer than those treated with placebo (Z = -2.27; P < 0.05). From the 10th day onwards, a greater reduction of craving was observed in the ALC 1 g group than with placebo (P = 0.035). The two groups did not differ in the percentage of subjects remaining abstinent for the entire study period or the number of subjects who relapsed (defined as five or more standard drinks (four for women) on a single occasion or drinking on five or more days in 1 week). CONCLUSIONS: The results of this study suggest that ALC can reduce craving and the time to first drink. ALC use was safe. Further studies are needed to clarify to confirm, over longer periods, these short-term outcome benefits.

Behavioural addictions in bipolar disorder patients: role of impulsivity and personality dimensions.

BACKGROUND: Behavioural addictions (BAs) can be understood as disorders characterized by repetitive occurrence of impulsive and uncontrolled behaviours. Very few studies have investigated their association with mood disorders. The present study was undertaken to determine the prevalence of the main behavioural addictions in a sample of bipolar outpatients in euthymic phase or stabilised by medications and to investigate the role of impulsivity and temperamental and character dimensions. METHODS: One-hundred-fifty-eight Bipolar Disorder (BD) (DSM-IV) outpatients were assessed with tests designed to screen the main behavioural addictions: pathological gambling (SOGS), compulsive shopping (CBS), sexual (SAST), Internet (IAD), work (WART) and physical exercise (EAI) addictions. TCI-R and BIS-11 were administered to investigate impulsivity and personality dimensions mainly associated with BAs. The clinical sample has been compared with 200 matched healthy control subjects. RESULTS: In bipolar patients, 33% presented at least one BA respect to the 13% of controls. Significantly higher scores at the scales for pathological gambling (p<.001), compulsive buying (p<.05), sexual (p<.001) and work addictions (p<.05) have been found. Self-Directness (p=.007) and Cooperativeness (p=.014) scores were significantly lower while impulsivity level was significantly higher (p=.007) in bipolar patients with BA than those without BA. CONCLUSIONS: To our knowledge, this is the first study investigating the prevalence of behavioural addictions in BD showing a significant association of these disorders. BAs are more frequent in bipolar patients than in healthy controls and are related to higher impulsivity levels and character immaturity.

Pregabalin, tiapride and lorazepam in alcohol withdrawal syndrome: a multi-centre, randomized, single-blind comparison trial.

INTRODUCTION: The aim of this trial was to compare lorazepam with non-benzodiazepine medications such as pregabalin and tiapride in the treatment of alcohol withdrawal syndrome (AWS). These drugs were chosen for their inhibitorial effects on the hypersecretion of neurotransmitters usually observed in AWS. Craving reduction and improvement of psychiatric symptoms were the secondary end-points. METHODS: One hundred and ninety subjects affected by current alcohol dependence were considered consecutively: 111 were enrolled and divided into three groups of 37 subjects each. Within a treatment duration of 14 days, medication was given up to the following maximum doses (pregabalin 450 mg/day; tiapride 800 mg/day; lorazepam 10 mg/day). Withdrawal (CIWA-Ar), craving [visual analogue scale (VAS); Obsessive and Compulsive Drinking Scale (OCDS)], psychiatric symptoms [Symptom Check List 90 Revised (SCL-90-R)] and quality of life (QL-index) rating scales were applied. RESULTS: On the CIWA-Ar score, all the groups showed a significant reduction between times (P < 0.001) with a higher reduction for the pregabalin group (P < 0.01) on items regarding headache and orientation. Retention in treatment was lower in the tiapride group (P < 0.05), while the number of subjects remaining alcohol free was higher in the pregabalin group (P < 0.05). Significant reduction between baseline and the end of the treatment was found in all the groups at the OCDS and the VAS for craving, at the SCL-90-R and QL-index (P < 0.001). DISCUSSION: All the medications in the trial showed evidence of safety and efficacy in the treatment of uncomplicated forms of AWS, with some particular differences. The efficacy of pregabalin was superior to that of tiapride, used largely in research trials and, for some measures, to that of the 'gold standard', lorazepam. Accordingly, pregabalin may be considered as a potentially useful new drug for treatment of AWS, deserving further investigation.

Empathy ability is impaired in alcohol-dependent patients.

Empathy is a complex form of psychological inference in which observation, memory, knowledge and reasoning are combined to yield insights into the thoughts and feelings of others. The aim of this study was to evaluate the level of empathy in a sample of alcohol-dependent patients in comparison to a control sample. One hundred and fifty alcohol-dependent subjects were consecutively recruited. All of the subjects successfully detoxified have been evaluated with the Empathy Quotient (EQ) and then compared with 107 control subjects. The level of empathy was significantly lower in the group of alcohol-dependent subjects than in the control sample (p <.001). Differences with respect to gender and psychiatric comorbidity have also been observed. A low level of empathy could be a psychological trait typically observed in pre-morbid alcoholic personalities. Further, the lack of empathy could lead latent abusers to find in the alcohol misuse something enabling them to compensate for their intrinsic weakness.

Clinical features, response to treatment and functional outcome of bipolar disorder patients with and without co-occurring substance use disorder: 1-year follow-up.

INTRODUCTION: Bipolar disorder patients (BP) with comorbid Substance Use Disorder (SUD) may present clinical features that could compromise adherence and response to pharmacological treatment. The purpose of this study was to examine clinical and psychopathological features of BP with and without comorbid SUD in a real-world setting. METHODS: The sample was composed by 131 affective patients. Sixty-five patients were affected by Bipolar Disorder I (BP-I, 49.2%), 29 by Bipolar Disorder II (BP-II, 22.3%) and 37 by Cyclothymic Disorder (CtD, 28.5%), according to DSM-IV. Sixty-six patients were diagnosed for a comorbid SUD. All patients have been submitted to psychometric assessment with Hamilton Depression Rating Scale (HDRS), Hamilton Anxiety Rating Scale (HARS), Young Mania Rating Scale (YMRS), Global Assessment Scale (GAS), Social Adjustment Self-reported Scale (SASS), Quality of Life Scale (QoL), at baseline and repeated follow-up periods (1, 3, 6, 12 months). RESULTS: BP comorbid for SUD were more likely diagnosed as BP-II and CtD and were less likely to present a moderate-severe manic symptomatology. Furthermore, personality disorders were more frequent in SUD patients than in non-comorbid BP. BP with SUD were not different for primary outcome measure (HDRS, HARS, YMRS, GAS) from non-comorbid BP; however, BP with SUD were significantly more impaired in social functioning (SASS) at any stage of the follow-up and poor functioning increased the risk of relapse in substance use during treatment. Finally, SUD comorbidity did not represent a risk factor for treatment drop-out, while in our sample young age, low treatment dosage and BP-I diagnosis were significantly associated with drop-out. DISCUSSION: The primary finding of this work is that BP with comorbid SUD are significantly more compromised in social functioning. Second, these patients were less likely to be diagnosed for BP-I and to present a severe manic symptomatology. Finally, we found that the diagnosis of SUD, but young age, low treatment dosage and BP-I diagnosis to be risk factors for treatment drop-out. Physicians should be alert to these differences in their clinical practice.

Efficacy and safety of pregabalin in alcohol dependence.

INTRODUCTION: Pregabalin is a new anxiolytic that selectively binds to the alpha2-delta subunit of voltage-gated calcium channels, inhibiting release of excessive levels of excitatory neurotransmitters. In this open-label trial we aimed to investigate the efficacy of pregabalin on alcoholism indices in detoxified alcohol-dependent subjects. Reduction of cravings, psychiatric symptom improvements, and the evaluation of safety parameters were the secondary endpoints. METHODS: Thirty-one alcohol-dependent patients were consecutively recruited and screened for the study. Twenty detoxified patients received pregabalin starting at 50 mg/day (orally) in the first week, gradually increasing to a flexible dose of 150-450 mg/day. Subjects were assessed at the beginning of the treatment, and after 2, 8 and 16 weeks. Craving (visual analogue scale, Obsessive and Compulsive Drinking Scale [OCDS]) and withdrawal (Clinical Institute Withdrawal Assessment for Alcohol [CIWA-Ar]) rating scales were applied; psychiatric symptoms were evaluated through the Symptom Check List-90-Revised (SCL-90-R). RESULTS: Out of the twenty patients who received the study drug, 15 completed the study procedures: 10 remained totally alcohol-free for the duration of the study, five relapsed. An additional four patients dropped out during the study, and one stopped taking medication due to adverse events. A significant progressive reduction of both craving and withdrawal symptomatology were observed. Safety parameters did not show any significant variation during treatment. CONCLUSION: Pregabalin shows promise as a treatment for alcohol dependence. Although limited by a low number of participants and by the open design, this is the first study concerning the efficacy and safety of pregabalin in current alcoholics. In these patients pregabalin was effective and well tolerated. Additional research is needed to explore the clinical relevance of these findings.