Active clinical trials for "Alcohol Drinking"

The overall objective of the proposed research is to reduce the incidence of sexually transmitted infections (STIs) among college students. The investigators propose to accomplish this by using the innovative, engineering-inspired multiphase optimization strategy (MOST) to develop a highly effective, appealing, economical, and readily scalable internet-delivered behavioral intervention targeting the intersection of alcohol use and sexual risk behavior. The rate of STIs on college campuses is alarming: one in four college students is diagnosed with an STI at least once during their college experience. Sexual activity when drinking alcohol is highly prevalent among college students. Alcohol use is known to contribute to the sexual risk behaviors that are most responsible for the transmission of STIs, namely unprotected sex, contact with numerous partners, and "hook-ups" (casual sexual encounters). Few interventions have been developed that explicitly target the intersection of alcohol use and sexual risk behaviors, and none have been optimized. In order to reduce the incidence of STI transmission among this and other high-risk groups, a new approach is needed. MOST is a comprehensive methodological framework that brings the power of engineering principles to bear on optimization of behavioral interventions. MOST enables researchers to experimentally test the individual components in an intervention to determine their effectiveness, indicating which components need to be revised and re-tested. Given the high rates of alcohol use and sex among college students, the college setting provides an ideal opportunity for intervening on alcohol use and sexual risk behaviors. The proposed study will include a diverse population of college students on 4 campuses which will increase the generalizability of the findings. The specific aims are to (1) develop and pilot test an initial set of online intervention components targeting the link between alcohol use and sexual risk behaviors, (2) use the MOST approach to build an optimized preventive intervention, and (3) evaluate the effectiveness of the newly optimized preventive intervention using a fully powered randomized controlled trial (RCT). This work will result in a new, more potent behavioral intervention that will reduce the incidence of STIs among college students in the US, and will lay the groundwork for a new generation of highly effective STI prevention interventions aimed at other subpopulations at risk.

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.

While a large focus of research on U.S. college drinking has focused on the prevalence of and problems related to heavy-episodic drinking, less has focused on college students who are either abstainers or lighter drinkers (i.e., for men, drinking 4 or fewer drinks in two hours and 14 or fewer drinks per week; and for women drinking 3 or fewer in two hours and 7 or fewer drinks per week). Over 40% percent of college students ages 18-22 do not report drinking in the past month with only half of those engaging in regular heavy-episodic drinking. Research suggests that a significant proportion of students who were abstinent or light drinkers prior to and upon entering college initiate drinking and progress to becoming heavy-episodic drinkers. This provides evidence that the first few months of college is a high-risk time for initiating both drinking and heavy-episodic drinking and that delaying the onset of heavy-episodic drinking among light drinkers and abstainers should lead to reduced harms throughout the college years and young adulthood. Mobile phone-based interventions are an innovative method for reaching young people and have been established as an empirical approach towards addressing health issues, including alcohol use. The ultimate goal of this proposal is to develop, refine and pilot a text message (TM) intervention for abstainer and lighter drinking first year college students with the ultimate goal of delaying alcohol initiation and/or reducing alcohol use escalation. An iterative process of focus groups, intervention content development, and user feedback focused on the unique experiences of abstainers and lighter drinkers will inform the TM Intervention to be delivered in a pilot study with 6 weeks of TMs. The pilot study will include a 6 week post-intervention assessment, and 3, 6, and 9 month follow-ups among 100 incoming first year abstainer and lighter drinker college students. Given that reducing young adults' and college students' engagement in excessive alcohol use has been listed as a major objective of Healthy People 2020 and a key priority of NIAAA, an intervention that focuses on delaying alcohol initiation and escalation into higher-risk alcohol use among abstainer and lighter drinkers could make important strides to achieving this goal.

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.

The overall objective of the proposed research is to reduce the incidence of sexually transmitted infections (STIs) among college students. The investigators propose to accomplish this by using the innovative, engineering-inspired multiphase optimization strategy (MOST) to develop a highly effective, appealing, economical, and readily scalable internet-delivered behavioral intervention targeting the intersection of alcohol use and sexual risk behavior. The rate of STIs on college campuses is alarming: one in four college students is diagnosed with an STI at least once during their college experience. Sexual activity when drinking alcohol is highly prevalent among college students. Alcohol use is known to contribute to the sexual risk behaviors that are most responsible for the transmission of STIs, namely unprotected sex, contact with numerous partners, and "hook-ups" (casual sexual encounters). Few interventions have been developed that explicitly target the intersection of alcohol use and sexual risk behaviors, and none have been optimized. In order to reduce the incidence of STI transmission among this and other high-risk groups, a new approach is needed. MOST is a comprehensive methodological framework that brings the power of engineering principles to bear on optimization of behavioral interventions. MOST enables researchers to experimentally test the individual components in an intervention to determine their effectiveness, indicating which components need to be revised and re-tested. Given the high rates of alcohol use and sex among college students, the college setting provides an ideal opportunity for intervening on alcohol use and sexual risk behaviors. The proposed study will include a diverse population of college students on 4 campuses which will increase the generalizability of the findings. The specific aims are to (1) develop and pilot test an initial set of online intervention components targeting the link between alcohol use and sexual risk behaviors, (2) use the MOST approach to build an optimized preventive intervention, and (3) evaluate the effectiveness of the newly optimized preventive intervention using a fully powered randomized controlled trial (RCT). This work will result in a new, more potent behavioral intervention that will reduce the incidence of STIs among college students in the US, and will lay the groundwork for a new generation of highly effective STI prevention interventions aimed at other subpopulations at risk.

A brief negotiational interview (BNI), administered in an Emergency Department setting for both hazardous and harmful drinkers has been shown to cost-effectively reduce a patient's alcohol intake and re-injury rate up to 3 years post intervention. A BNI is a short (5-30 minute) counseling session administered by non-addiction specialists based on the concepts of the FRAMES model of motivational interviewing. Text based boosters have been proposed to prolong the impact of this intervention, either with a standardized or personalized content. The investigators will conduct a pilot study to test the feasibility of the study protocols, acceptance of the intervention, and patient enrollment and retention rates, as we prepare for a fully powered pragmatic randomized adaptive controlled trial of the intervention for patients seen at the Kilimanjaro Christian Medical Center (KCMC) Emergency Department.(ED)

The purpose of the proposed study was to develop a family-based drinking prevention intervention for Latino emerging adults (EAs) and Latino parents of EAs. Although drinking rates for Latinos are lower than those for Whites in terms of the prevalence of alcohol use, the consequences of alcohol use (e.g., drunk driving, unplanned/unprotected sex, alcohol-related injuries) appear to be more severe for Latinos, especially those 18-23 years old. The investigators developed a brief (4 session) intervention for each of EAs and parents focused on identity development and parent support for EAs, respectively.

A pilot randomized controlled trial was carried out. Fifty nursing students were randomly assigned either a 50-minute brief motivational intervention with individual feedback or a treatment-as-usual control condition. The intervention was delivered by undergraduate peer counsellors trained in Brief Alcohol Screening and Intervention for College Students. Primary outcomes for testing efficacy were alcohol use and alcohol-related consequences.

This project will develop an intervention delivered through text messaging to reduce alcohol consumption and high risk drinking among adults who are enrolled as students in community colleges.

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.