61 Clinical Trials for Various Conditions
This study will assess effects of tetrahydrocannabinol (THC) and THC + alcohol in marijuana users on prefrontal brain activity, using functional near-infrared spectroscopy (fNIRS) during resting state and during memory task performance. Participants will complete fNIRS testing 120 minutes following THC or identical placebo (Phase 2A), or THC/ethanol, THC/placebo ethanol, placebo THC/ethanol, and placebo THC/placebo ethanol (Phase 2B), and oxygenated hemoglobin (HbO) concentration will be measured.
The Responsible Retailing Forum ("RRF") seeks to develop a new intervention, Stop Service to Obviously- Impaired Patrons ("S-STOP"), to reduce the incidence and harm associated with overservice of alcohol. Modeled after RRF's effective program to reduce alcohol sales to minors using Mystery Shopper feedback on staff ID-checking conduct, SSTOP would (1) conduct "Pseudo-Intoxicated" Mystery Shop" ("P-I/MS") inspections of serving establishments, employing actors who seek to purchase an alcohol beverage while showing obvious signs of intoxication, (2) provide licensees with confidential feedback on actual staff conduct and a video link to view the behavior of the P-I/MS that visited their establishments, (3) provide staff with brief online training in the recognition and skillful refusal of service to intoxicated patrons, and (4) provide communities with a measure of the prevalence of overservice. The proposed study will: (1) determine the effectiveness of S-STOP in improving recognition and refusal to serve an obviously- impaired customer. To do this, we will implement S-STOP in 10 pairs of demographically matched college and university communities, employing a cross-over design. After a 3-month baseline, we will implement S- STOP in one community in each pair (Cohort 1), while the second community serves as a control (Cohort 2). After 6 months, we will end S-STOP in Cohort 1 communities but continue inspections to measure the effects of decay; and we will begin S-STOP in Cohort 2. (2) examine how licensees utilize the S-STOP program and the extent to which utilization moderates the effectiveness of the program. To do this, we will measure the number and percentage of managers who visit the S-STOP website and register their staff for training, measure the number of staff that complete the training, and conduct analyses to investigate the dose-response relationship between utilization of the S-STOP program and likelihood of overservice. (3) investigate why some owner/managers did not participate in S-STOP. To achieve this, we will interview 20 owner-managers who did not access the S-STOP website.
This study is a prospective, controlled study in healthy volunteers all of whom are residents, medical students, faculty physicians, or emergency department nursing and ancillary staff.
This will be a (2 visit) double-blind, randomized, placebo crossover design clinical study to assess the potential benefits of FSD-F2R6-A-CP versus a placebo by assessing its impact on side effect profiles as well as cognitive abilities, motor abilities, and breath alcohol concentration following ingestion of alcohol followed by the dietary supplement or placebo. This study will enroll healthy men and women.
This is a randomized, parallel-group study designed to explore the differences between cannabis intoxication, alcohol intoxication and co-intoxication involving both alcohol and cannabis, utilizing electroencephalography (EEG) as well as more traditional intoxication measures such as breath alcohol concentration and balance metrics. If eligible for the study, participants will be randomized to complete one study session in our mobile laboratory, during which they will use either alcohol, cannabis (which will be self-administered, ad libitum) or both alcohol and cannabis.
Alcohol intoxication is responsible for a large proportion of violent crime/assault and personal injury in our society. While a number of variables have been associated with alcohol-related aggression, high trait aggression and impaired executive function have been identified as key factors. Both Alcohol Use Disorder (AUD) and Impulsive Aggression behavior (AGG) are related to impaired social-emotional information processing (SEIP) whereby social threat cues, especially ones that are ambiguous in nature, lead to hostile attribution and negative emotional response to the "other" and, then, aggression against the "other". Thus, understanding the underlying neuroscience of SEIP under the influence of alcohol will be critical to identifying targets for intervention to reduce alcohol-related aggressive behavior. In addition to potential pharmacologic and cognitive-behavioral based interventions, such interventions may also involve the rehabilitation of aberrant neuronal circuits underlying social cognitive function through neuroplasticity-based remediation exercises. This study is designed to see how brain activation of cortico-limbic circuits involving social-emotional information processing, analyzed by fMRI Imaging, are impacted by alcohol administration in those with and without aggressive disorders and with and without alcohol use disorder.
The goal of this experimental study is to examine the effect of alcohol, gender, and bystander attitudes on bystander barriers and sexual violence intervention among young adult men and women (age 21-20). The main questions it aims to answer are: * Does alcohol intoxication and gender influence bystander barriers and sexual violence intervention? * Does alcohol intoxication have a greater impact on bystander barriers and sexual violence intervention among men, compared to women? * Does alcohol intoxication have a greater impact on bystander barriers and sexual violence intervention among those with higher, compared to lower, prosocial bystander attitudes? Participants will be randomly assigned to one of two beverage conditions (alcohol or control beverage) and those assigned to alcohol will complete the study on either the ascending or descending alcohol limb. Participants will project themselves into a heat-of-the moment, risky sexual violence scenario that will assess bystander barriers and behavioral intentions. Researchers will compare those assigned to the alcohol and control beverage condition and men/women to see if this impacts bystander barriers and sexual violence intervention.
Background: People who binge drink are more likely to have risky sexual encounters, and alcohol changes brain activity associated with reward decisions related to those behaviors. Researchers want to better understand how alcohol s effects on risky sexual behavior that might lead people to contract sexually transmitted diseases (STDs) like HIV, the virus that causes AIDS. Objective: To study how alcohol impacts decisions about engaging in risky sex. Eligibility: Healthy adults ages 21-65 without alcohol use disorder Design: Participants will have 2 study visits, 1 month apart. They will arrive and depart via taxi. They will consume alcohol at 1 visit, chosen at random. At visit 1, participants will answer questions about HIV knowledge, HIV risk behaviors, and sexual interests. They will view pictures of clothed people and pick those they might have sex with. They will think about the person s risk of having an STD and whether they would use a condom during sex. At both visits, participants will sit in a bar-like room and have 2 drinks that may contain alcohol. Then they will have magnetic resonance imaging (MRI) brain scans. For this, they will lie on a table that slides in and out of a metal tube. The scanner makes loud noises; they will get earplugs. They will complete tasks that include looking at pictures and making choices about money. At the beginning of both visits the participants will be screened with urine drug test and pregnancy test. Duiring each visit the participants breath alcohol will be measured, and they will discuss whether they feel intoxicated. Participants will get snacks and stay at the clinic for up to 6 hours after the MRIs.
This study aims to develop a phone app to assess gait differences at different levels of alcohol intoxication.
1. The major aims are to assess: (1) the relationship of basal and alcohol-induced neurosteroid and GABA levels to the degree of acute alcohol intoxication in healthy male and female volunteers; and (2) the effect of acute pregnenolone administration on the degree of acute alcohol intoxication in these same volunteers. Specific hypotheses are: * Baseline serum levels of pregnenolone, pregnenolone sulfate (PS), dehydroepiandrosterone (DHEA) and DHEA sulfate (DHEA-S) will be inversely correlated with the magnitude of acute behavioral responses to alcohol (sedation, anxiolysis, amnesia, psychomotor impairment and intoxication). That is, higher baseline levels of these neurosteroids will be associated with lessened behavioral responses to alcohol. * Baseline serum levels of allopregnanolone, tetrahydrodeoxycorticosterone (THDOC), androstanediol, androsterone and GABA will be directly correlated with the magnitude of acute behavioral responses to alcohol. That is, higher baseline levels of these substances will be associated with heightened behavioral responses to alcohol. * Acute alcohol ingestion, compared to placebo ingestion, will increase serum levels of allopregnanolone and THDOC and plasma levels of GABA and will decrease plasma levels of PS. (Effects on levels of other neurosteroids are not specifically predicted based on animal data but will be examined in an exploratory manner.) * Acute alcohol-induced increases in serum levels of allopregnanolone and THDOC and in plasma levels of GABA will be directly correlated with the magnitude of acute behavioral responses to alcohol. Acute alcohol-induced decreases in serum levels of PS will be directly correlated with the magnitude of acute behavioral responses to alcohol. Correlations between alcohol-induced changes in other neurosteroids and changes in behavior are not specifically predicted but will be examined in an exploratory manner. * Pregnenolone, compared to placebo, pre-treatment will antagonize the acute effects of alcohol on the behavioral measures.
Intimate Partner Sexual Violence (IPSV) is a significant and understudied public health problem among sexual minority (SM) and heterosexual couples, yet little is known about factors that contribute to IPSV perpetration. This proposal aims to determine the acute effect of alcohol and sexual communication on IPSV. In this study, 240 couples (50% SM) who drink alcohol will be recruited from the Metro-Denver area. Upon arrival to the laboratory, a trained research assistant will check the participant's ID, verify that they adhered to the pre-session guidelines, administer a breath test to ensure a breath alcohol content (BrAC) of 0.00 and conduct a field sobriety test. They will also obtain informed consent for each member of the couple separately. Female participants will take a pregnancy test to ensure a negative result. All participants will complete measures to reverify eligibility criteria and be weighed to determine their correct alcohol dose. Partners will separately complete a baseline survey measuring demographic factors, alcohol use, sexual communication, and daily experiences. After completing the survey, participants will be assigned a beverage condition (alcohol or no-alcohol control) and couples will be randomly assigned to a sexual communication condition (direct verbal or indirect verbal). Participants will be seated in a room separate from their partner, where they will drink an alcoholic or no-alcohol control beverage. Upon reaching a breath alcohol content (BrAC) of .08, or immediately after drinking in the No-Alcohol control condition, participants will complete a laboratory assessment of sexual violence. The main hypotheses are: (1) one's alcohol use will increase IPSV toward partners who are also drinking, (2) one's alcohol use will increase IPSV among partners who use indirect, relative to direct, sexual communication, and (3) actor alcohol use will increase IPSV toward partners who are also drinking and use indirect, relative to direct, sexual communication.
The goal of this clinical trial is to examine how alcohol affects young adults' attention in both laboratory and real-world settings through phone-based cognitive tasks. The main questions this trial is designed to answer are: * How well do the phone-based cognitive tasks capture alcohol's effects on attention? * Does the effect of alcohol on attention contribute to risk-taking? Participants will complete cognitive tasks to assess attention before and after consuming a standard amount of alcohol in the laboratory, and during surveys completed through a phone app for eight weekends.
Sexual violence (SV) is a significant public health problem particularly among 18-24 year old populations. A major risk factor for SV is alcohol use, which via its negative impact on cognitive abilities and decision-making acts as a barrier to intervening in situations at-risk for a SV. This study has two main goals: (1) to determine the effects of proximal alcohol use on young (age 21 to 25) men's prosocial bystander behavior in situations considered at-risk for SV, and (2) to determine the efficacy of an evidence-based, web-based program called RealConsent, which has been augmented to include alcohol-specific content within the context of bystander SV ("RealConsent2.0"), on men's prosocial bystander behavior. The primary study endpoint is prosocial bystander behavior and will be assessed via two modes: (1) a virtual reality (VR) environment ("B-SAVE") and (2) a validated self-report measure of bystander behavior that has been modified to include assessment of proximal alcohol use and presence of alcohol within the context.
Given the public health and social relevance of sexual aggression and the gap in the extant literature regarding state anger, emotion regulation, alcohol, and sexual aggression, the present study will contribute to our understanding of emotion regulation's role in sexual aggression perpetration. The proposed 2-year research plan will examine the effects of alcohol intoxication, state anger, and emotion regulation on men's sexual aggression intentions. This study will recruit non-monogamous, men (individuals who identify their gender as male and whose biological sex is male) who have sex with women, ages 21-35. While more research on female perpetrators is needed, the proposed study will exclusively recruit males for the following reasons: 1) the scientific literature indicating the majority of sexually aggressive acts are perpetrated by men; and 2) the current sexual aggression analog has not been piloted with female participants and would require preliminary experiments to determine its appropriateness. The study will utilize a 2x2 design in which participants are randomized to beverage condition \[alcohol (target BAC= .08gm%) or control (no alcohol control)\] and an emotion induction (anger induction or control). The outcomes will be assessed using a sexual aggression analog which participants will complete on the descending limb of alcohol intoxication and indicate the likelihood that they would engage in various sexually aggressive acts. The study also includes self-report measurements of state anger and emotion regulation to explore emotion regulation as a moderator in the associations among alcohol intoxication, state anger, and sexual aggression intentions.
The present project integrates previous research on factors associated with alcohol-involved sexual assault, with research on how intoxication alters attention and social perceptions in ways that increase the risk of sexual aggression and victimization. Specifically, this project examines whether alcohol intoxication on the part of a male perpetrator impairs attentional capacity and leads to a narrowing of the perceptual field causing a dehumanizing perspective of women as sexual objects for men's pleasure rather than individuals with thoughts and feelings, thereby increasing the propensity for sexual aggression. The present research also examines whether women's responses to this sexual objectification from men interfere with risk perception in sexual situations, particularly when women are drinking, increasing the likelihood of sexual victimization.
This study is designed to test LabPatch-alcohol, a wearable, non-invasive biosensor Band-Aid like patch that is designed to detect real-time changes in interstitial alcohol concentrations in human subjects. The changes in interstitial alcohol concentrations will be compared to blood alcohol concentrations to determine the patch's validity against the gold standard.
Background: Many bacteria live in the gut. The gut is the tube that moves food from the mouth through the stomach to the intestines. Heavy alcohol use disturbs these bacteria. There is evidence that the bacteria in the gut may affect anxiety and depression. Researchers want to learn more about these bacteria in order to better treat diseases such as alcohol dependence. Objective: To identify the different bacteria that live in the mouth and gut. Also, to learn if these bacteria change as a person goes through alcohol detoxification. Eligibility: People ages 18 and older who: * Enrolled in screening protocol 14-AA-0181 * Are going through detoxification treatment at the Clinical Center Design: Participants will have physical exams. Participants will answer questions about: * Anxiety and depression * Alcohol use * Sleep * Abdominal and oral health * Diet Participants will keep a regular record of their diet. Participants will have breath alcohol analysis 4 times per day. Participants will provide stool and oral specimens at most once a day for the first week. Then, they will provide them once a week while they are at the Clinical Center. * For the oral specimen: A small brush rubs the tongue. They may not eat, drink, or perform oral care within 2 hours of collection. * For the stool specimen: They will receive a container that fits in the toilet. They will let the nurse know right away when the sample is ready. Participants will have a dental visit. This consists of an oral exam and oral health assessment. The dentist may recommend a cleaning or dental X-rays.
This will be a prospective survey study. The participants will all be volunteers of legal drinking age. Each participant will consume one alcoholic beverage (beer) at a time and then will be asked to verbally estimate their current blood alcohol concentration and if the subject feels they are able to drive. At that time, their BAC level will be measured objectively using a breath alcohol test (BAT) device. The participant will not be told their objective value. This will continue with a verbal estimate and actual BAT reading after every drink until the participant reaches a minimum BAC of 0.10. At this time, participants will continue to be monitored until their BAC falls to 0.08 and they are clinically sober. As their blood alcohol level decreases, the investigators will ask the participant to estimate their level every hour along with an actual reading until reaching 0.08. Statistical analyses will be used to determine how accurate self estimation is in regards to blood alcohol content.
This study is intended to evaluate the prevalence of chronically inebriated patients in the Emergeny Department (ED). Patients will be identified prospectively by screening all patients (24/7) presenting to the ED for one month. A running tally of all patients in the ED will be kept. Of these patients, any patient that is noted to have alcohol intoxication will be identified. The chart of that patient will be reviewed for details about the patient's alcohol use and for the patient's suitability for a sobering house, which is a place where intoxicated patients can go to await sobriety. The chart will also be reviewed for the number of previous visits for alcohol use to our hospital ever and in the last year.
This study will test the reliability of a procedure for self-administering ethanol (alcohol) intravenously (through a vein), using a computer-assisted method. People ordinarily self-administer alcohol through drinking alcoholic beverages, but blood alcohol levels resulting from drinking vary greatly among individuals. For research on alcohol dependence and treatment, a tool for achieving precise blood levels is needed. In addition to testing this method of alcohol administration, the study will examine self-administration behavior and resulting breath alcohol concentration, the effects of alcohol on the participants, and differences between men and women in alcohol self-administration. Healthy normal volunteers between 21 and 45 years of age may be eligible for this study. Participants are assigned to one of two study groups. Group 1 undergoes three 7-hour study sessions and group 2 participates in two sessions, each of which includes the following procedures: * Breathalyzer and urine tests for alcohol and illicit drug use. * Urine pregnancy test for women. * Light lunch. * Questionnaire about health and recent drinking. Alcohol infusion: Subjects are seated in a comfortable chair and instructed on how to use a computer to give themselves a short infusion of alcohol through a catheter (plastic tube) that has been inserted into a vein in their the arm. Sensors are placed on their chest to monitor heart beat and their neck to record skin blood flow. At the start of the session, subjects complete questionnaires about any drug effects and urges to drink they may be feeling. They are trained on how to use the computer to administer alcohol and are then allowed to self-administer alcohol through the catheter any time they like, as long as their peak breath alcohol level does not exceed 0.1 g% (a level that would result from ingestion of 4 to 6 drinks in most people). If that point is reached, the computer automatically inactivates self-administration until the level is lowered again. Breathalyzer readings are taken every 15 to 30 minutes. Subjects may read, watch television or videos or listen to music during the sessions. Recovery: At the end of the 2.5 hours of self-administration, the catheter is removed and subjects can eat, read, watch television and relax in the clinic until their breath alcohol level falls below 0.02 g%, usually after 2.5 to 3 hours, when they can go home by taxi or with a pre-arranged designated driver.
The purpose of this study is to test the efficacy of an individual motivational interview for reducing alcohol and marijuana-related harm as well as alcohol and marijuana use in incarcerated teens.
The primary goal of the study is to assess the residual effects of heavy drinking on academic performance. The investigators will also explore whether these effects differ by family history of alcohol abuse and hangover symptoms, as well as compare males and females with respect to these effects. The primary hypothesis is that intoxication (0.10 g% blood alcohol concentration \[BAC\]) with an alcoholic beverage impairs next-day academic performance, as measured by scores on quizzes, standardized academic achievement tests, and standardized neurobehavioral assessments. The secondary hypothesis is that family-history-positive individuals will show a greater performance decrement the day after heavy drinking than family-history-negative individuals.
This protocol has three purposes: (1) to evaluate subjects for inclusion or exclusion from other NIAAA protocols; (2) to provide a common set of descriptive information that will be available on all NIAAA research subjects; (3) to allow NIAAA medical and nursing staff to treat alcoholic patients for acute alcohol intoxication or alcohol withdrawal before requiring patients to consent to evaluation for participation in research studies. Information collected will include such items as psychiatric diagnoses, presence or absence of brain, liver or other organ damage, history of the amount of past alcohol consumption, other substance use and family history of alcoholism. This information will allow investigators to determine for which, if any, NIAAA research studies a subject is eligible. In order to avoid requiring intoxicated subjects to consent for procedures such as HIV testing, psychiatric interviews, and Magnetic Resonance Imaging (MRI) of the brain we will obtain consent from all alcoholic subjects in two phases, using two separate consent forms. The first consent form will express the subject's desire to be admitted to the NIAAA inpatient unit for the purpose of treatment for alcoholism and will authorize only medical evaluation and treatment for alcoholism and associated problems. After an alcoholic subject has been admitted to the inpatient unit and is judged to be no longer intoxicated or suffering from acute alcohol withdrawal he or she will be presented with the second consent which will describe the evaluation for participation in other NIAAA research studies. Non-alcoholic, healthy controls will sign only one consent form describing the data to be collected and evaluation for participation in other NIAAA research studies.
The new recreational marijuana markets are contributing to polysubstance-impaired driving and other harms, especially when marijuana is used in combination with alcohol, by selling marijuana to obviously-intoxicated customers. In this study, the effectiveness of an intervention to reduce the risk of marijuana sales to obviously-intoxicated customers will be tested in the state-licensed recreational marijuana market in Oregon, one of the first states to ban such sales. The intervention will combine efforts by state regulators to increase deterrence of the state law prohibiting marijuana sales to obviously-intoxicated customers with training of store personnel to recognize signs of intoxication and refuse sales. It will also include testing the rate at which visibly intoxicated customers are refused alcohol at nearby establishments that sell alcohol either on-site or off-site
Responsible Beverage Service Training (RBS) has been shown to be effective and recent research by this research team has shown that online RBS training (WayToServe®) was more effective, particularly over time, than usual and customary (UC) RBS training by live trainers. However, one growing segment of alcohol servers and sellers has been neglected in RBS training efforts: Hispanic primarily Spanish-speaking servers in predominantly Spanish-speaking premises. This project will develop and test the first online RBS training for predominantly Spanish-speaking servers, WayToServe Español, which is culturally and linguistically appropriate and will fill a gap in evidence-based alcohol prevention interventions for this underserved population.
The purpose of this study is to determine whether brief motivational interviews reduce problematic drinking behavior among individuals arrested for the first time for driving under the influence of alcohol (DUI).
The purpose of this study is to determine whether brief motivational interviews reduce the likelihood of driving under the influence of alcohol (DUI).
This study examines the role of alcohol use in understanding the dynamics of romantic relationships. Couples will participate in a research session where they consume either an alcoholic or non-alcoholic beverage and complete study tasks. After the session, participants will provide information about their drinking habits, alcohol- and non-alcohol-related experiences, and relationship factors through brief surveys on their smart phones and again at 6-month and 12-month follow-up sessions. The findings from this study aim to improve understanding of alcohol use in close relationships and may inform future strategies for promoting healthier relationships and behaviors.
In this study, the investigators aim to capture inter- and intra-brain mechanisms underlying alcohol reward in novel social context.
This human laboratory study will use cognitive, behavioral, and subjective measures to characterize impairment associated with co-use of alcohol and vaporized cannabis. Participants (n=32) will complete 7 double-blind, double-dummy outpatient sessions in randomized order. In each session, participants will self-administer placebo (0 mg THC) or active vaporized cannabis (5 or 25 mg THC, via a handheld vaporizer called the Mighty Medic) and a placebo drink (BAC 0.0%) or alcohol drink calculated to produce a breath alcohol concentration (BAC) of 0.05%. Participants will also complete a positive control session in which the participant administers placebo cannabis and alcohol at a target BAC of 0.08% (the legal threshold for driving impairment in most U.S. states).