Active clinical trials for "Alcoholism"

The purpose of the study is to determine whether welfare-to-work schemes combined with alcohol treatment are more efficient than a welfare-to-work scheme alone, for unemployed citizens with alcohol problems.

This research will determine whether the Chinese herbal medicine (NPI-028) can make a significant contribution to the management of withdrawal and to follow-up treatment aimed at preventing or managing relapse in both women and men alcoholics. The herbal preparation has been used historically in the treatment of alcohol intoxication and is still prescribed in China and Southeast Asia. Efficacy has been documented but awaits the application of current research methods to establish efficacy, safety, and probable mechanisms of action. Preclinical studies have been carried out in alcohol-preferring rats and vervet monkeys to test efficacy in reducing voluntary alcohol intake, measure tolerance effects, and toxicological affects. The proposed human trial will develop a placebo, establish quality control, test methods of administration, and examine compliance issues. Following these preliminary steps, a placebo controlled trial will be conducted using 160 subjects (80 subjects per treatment condition with 40 of each gender). Alcohol use, craving, health status, psychological status, and at rates will be assessed using established measures that are current in addiction research.

Cross-sectional and prospective studies are proposed to test the prediction that a higher proportion of HIV+ individuals with hazardous alcohol drinking with subclinical fasting dysglycemia will present with impaired oral glucose tolerance and dysfunctional metabolic skeletal muscle phenotype. Prospective studies will test the efficacy of an exercise intervention in improving glycemic control. Results will inform larger scale interventions to ameliorate metabolic comorbidities, improve health, quality of life, and possibly decrease hazardous alcohol drinking.

The objective of this study is to determine if, compared to placebo, zonisamide (400mg/day) is a safe and efficacious treatment for post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD) in Veterans with PTSD and co-occurring AUD.

To further test the effectiveness of oxytocin in heavy drinkers, half of the cohort in the proposed study will meet criteria for heavy drinking (>35 standard drinks/week [men], >28 standard drinks/week [women] for at least 4 consecutive weeks). However, the investigators think it important to expand the cohort of the proposed study to include subjects with moderate Alcohol Use Disorder (AUD) who meet lower drinking criteria so the outcome of the study will be relevant to a larger percentage of individuals who have AUD. The lower drinking criteria will be minimum of 14 drinks/week (women) or 21 drinks/week (men) with an average of at least two heavy drinking days (≥5 standard drinks for men and ≥4 standard drinks for women) each week in the 4-week period prior to screening. As in the R21-funded Preliminary Study, individuals recruited from the community who meet study criteria based on assessment during a screening clinic visit will be randomized to twice a day (BID) intranasal oxytocin or intranasal placebo during a subsequent clinic visit. After instruction by research staff during the randomization clinic visit, subjects will self-administer intranasal treatments from blind-labeled spray bottles that they take home. During clinic visits at 1, 2, 3, 4, 6, 8, 10, and 12 weeks after randomization, drinking since the last visit will be quantified and other measures summarized above will be obtained. Subjects will self-administer test intranasal treatments for 12 weeks. Drinking will also be quantified during clinic visits at 6 and 12 weeks after cessation of intranasal treatments. This clinical trial will be the first adequately powered, double blind, placebo-controlled trial examining the efficacy and tolerability of BID intranasal oxytocin (40 IU/dose; 80 IU/d) on alcohol drinking in AUD. The trial will also be the first to prospectively examine the effects of intranasal oxytocin on anxiety symptoms in individuals with AUD.

This will be a laboratory-based investigation of the behavioral and neural effects of intranasal oxytocin on craving for alcohol and approach bias in moderate to heavy alcohol using subjects. This study uses a within-subject, randomized, placebo-controlled, counterbalanced, crossover design to compare the effects oxytocin and placebo. In this way, all subjects will be scanned twice; once following oxytocin administration and once following placebo administration, and will complete a series of behavioral tasks (both in and out of the scanner) at both visits.

The objective of this proposal is to advance medication development for alcohol use disorder by examining the efficacy and mechanisms of action of minocycline, a neuroimmune modulator, as a potential treatment. This study has important clinical implications, as the available treatments for alcohol use disorder are only modestly effective and testing novel medications is a high research priority.

The objective of this trial is to determine the effectiveness of an electronic cognitive behavioral therapy for insomnia (e-CBT-I) module in improving sleep and reducing alcohol use among heavy drinkers with insomnia. Specifically, it will test the effectiveness of Sleep Healthy Using the Internet (SHUTi), a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. The rationale for this mixed methods proposal is that effective, nonpharmacologic treatments are necessary to stem the highly comorbid public health problems of alcohol use disorder (AUD) and insomnia. If successful, SHUTi will represent a novel and easily accessible intervention for reducing alcohol intake among high-risk heavy drinkers.

The study primary end point is the decrease in the number of monthly heavy drinking days (HDD) (≥ 60 g/day in men and ≥ 40 g/d in women) from baseline to the end of the double blind Randomized Treatment (RT). The Secondary end points will be designed to assess safety and tolerability and to further investigate the effect of pitolisant on other alcohol use criteria (e.g. total alcohol consumption, number of abstinence days), craving as well as the improvement in mental health (depression, sleep) and quality of life. Total alcohol consumption (TAC) from baseline to end of treatment. TAC was defined as mean daily alcohol consumption in g/day over a month (28 days). Percent of patients without HDDs during the 24 weeks RT phase of the study. (Continuous Controlled Drinking=CCD) Percent of Abstinent Days during RT phase (PAD) Continuous Abstinence Duration from baseline during 24 weeks RT phase (CAD) 4-week point prevalence abstinence at end of treatment Improvement in alcohol biomarkers (e.g. ALAT, ASAT, % CDT) during 24 week RT phase Craving (Obsessive Compulsive Drinking Scale) during 24 week RT phase Beck Depression Inventory (BDI) during 24 week RT phase Quality of sleep (Pittsburgh Sleep Quality Index) during RT phase. Treatment retention during 24 week RT Quality of life (SF-12) during RT phase Percent patients without HDDs during the OL follow up period Quality of life (SF-12) during OL phase Quality of sleep (Pittsburgh Sleep Quality Index) during OL phase Treatment retention OL phase Safety will be assessed by evaluation of treatment emergent adverse events (TEAE), physical examinations, clinical laboratory tests (blood chemistry, hematology, and urinalysis), subsequent end of treatment potential withdrawal, evaluation scales and physical examination, measurement of heart rate, blood pressure, and body weight at each study visit )V0-FU5). If at ECG Fridericia's corrected QT interval ≥ 500 ms or if difference to baseline is ≥ 60 ms it will be required to check ECG by second measurement after lying down 10 minutes.

We propose to conduct a pilot study that will examine the utility and mechanisms of Mindfulness-Based Relapse Prevention in reducing alcohol consumption, relapse rates, and physiological arousal to stress in adults 21 years of age and older who have met DSM-IV-TR diagnostic criteria for alcohol dependence within the past year but have abstained from drinking for the last thirty days. MBRP is designed to improve one's ability to self-regulate emotions, thoughts and physical states, thus reducing the need to alleviate associated discomfort through substance use. Participants assigned to the intervention group will receive an 8-week training course of MBRP over a period of nine weeks; participants assigned to the Treatment As Usual (TAU) group will continue treatment as usual, which includes utilizing their own effective strategies to refrain from alcohol use. All participants will be assessed for pretreatment severity of psychological abuse/trauma as well as pre and posttreatment psychosocial functioning (e.g., alcohol consumption, symptoms of depression and anxiety, emotion regulation/coping). The outcome of treatment will be evaluated using a) Timeline Followback drinking data and b) self-report ratings of acquisition of MBRP skills (e.g., state/trait mindfulness, acceptance and awareness, and perceived stress) and depressive and anxiety symptom severity. We hypothesize that participants who receive MBRP training will demonstrate greater acceptance and awareness, reduced cravings, and have a lower likelihood of relapse than participants in the TAU group. It is also expected that MBRP participants will demonstrate greater improvements on psychological measures of depression, anxiety, emotion regulation and coping, and show less perceived stress and physiological arousal to stress compared to TAU participants. Finally, little is known about which types of individuals are most likely to benefit from MBRP. Thus, secondary analyses will help to clarify for whom MBRP may be most effective.