Treatment Trials

191 Clinical Trials for Various Conditions

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NOT_YET_RECRUITING
Social Facilitation of Alcohol Effects and Alcohol Misuse in Young Adults
Description

The purpose of this study is to understand social contexts and alcohol use. We hope to learn how being around peers affects alcohol consumption in young adults. About 250 young adults who drink alcohol frequently will take part in the study. This research is being funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA). Participation involves one in-person screening session with a same-sex platonic friend. Then participants will complete four in-person laboratory sessions where they will drink beverages containing alcohol or no alcohol. After completion of the laboratory sessions, participants will complete smartphone surveys for 28 days. Lastly, they will complete follow-up surveys 6 months and 12 months post-study enrollment.

COMPLETED
Influence of n-Acetylcysteine Maintenance on Alcohol Effects
Description

This study will evaluate the behavioral effects of alcohol during placebo and n-acetylcysteine maintenance using sophisticated human laboratory methods.

RECRUITING
Scaling Up: A Multi-Site Trial of e-SBI for Alcohol Use in Pregnancy
Description

The purpose of this research study is to find out if pregnant women screening positive for alcohol risk like the brief alcohol intervention application that the investigators have developed (called the MommyCheckup, which is a technology-delivered SBIRT, or e-SBIRT), and if it helps them to reduce alcohol use. The investigators also wish to test whether e-SBIRT effects can be enhanced by booster sessions and/or tailored text messages.

ACTIVE_NOT_RECRUITING
Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Substudy III
Description

The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.

ACTIVE_NOT_RECRUITING
Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Sub-Study II
Description

The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.

ACTIVE_NOT_RECRUITING
Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Sub-Study I
Description

The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.

ACTIVE_NOT_RECRUITING
Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition
Description

The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.

COMPLETED
Ability of Partial Inverse Agonist, Iomazenil, to Block Ethanol Effects in Humans
Description

Alcohol is abused commonly, but there is no remedy for alcohol intoxication. This project is looking at the substance iomazenil and its effect on alcohol intoxication and alcohol's effects on driving using a driving simulator.

COMPLETED
Characterizing the Effects of Family History of Alcoholism on Alcohol Analgesia
Description

Self-medication of pain with alcohol is a common, yet risky, behavior. Evidence suggests family history of alcoholism may affect the degree to which alcohol use relieves pain, but the independent contributions of expectation and conditioning have not been previously studied. Interactive effects of sex and family history are also currently unclear. This project addresses this gap in knowledge and will inform further research and clinical/translational efforts for reducing risk associated with these behaviors.

COMPLETED
Dissecting the Genetics of Fetal Alcohol Spectrum Disorders
Description

The purpose of this study is to help scientists understand why some people who were exposed to alcohol in the womb have special facial features but other people do not. This study will test if genetics (or DNA) explains these differences. We hope this will help improve treatments and interventions for people with fetal alcohol spectrum disorders (FASD). Participants in this study (or their parents or legal guardians) will be asked to: * Answer some questions about themselves. These questions ask about their demographic background (such as gender, race, ethnicity, income, and education), their health history, and their mother's health during her pregnancy with them (if that information is known). * Speak with study staff briefly by phone or video chat to confirm enrollment in the study and ask any questions they have. * Take photographs of their face. * Provide a saliva sample for genetic research. Participants can complete the study at home from anywhere in the world. The questions can be answered online, over the phone, or on paper. Adopted families are welcome to enroll. The study pays for all shipping costs.

COMPLETED
Acute Effects of Alcohol Use on Chronic Orofacial Pain
Description

Self-medication of pain with alcohol is a common, yet risky, behavior among individuals with chronic orofacial pain. Chronic pain status may affect the degree to which alcohol use relieves pain, but the independent contributions of pain chronification and alcohol-related expectations and conditioning have not been previously studied. This project addresses this gap in knowledge and will inform further research and clinical/translational efforts for reducing risk associated with these behaviors.

COMPLETED
A Study to Assess Potential Interaction Between ASP8062 and Alcohol in Healthy Adult Subjects
Description

The purpose of this study is to assess the potential for pharmacokinetic (PK) and pharmacodynamics (PD) interactions between ASP8062 and alcohol. This study will also assess safety and tolerability of a single dose of ASP8062 with or without alcohol.

COMPLETED
Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders
Description

The purpose of this study is to determine whether choline supplementation can improve cognitive functioning of children with prenatal alcohol exposure.

RECRUITING
Sex Differences in the Response to Abstinence From Alcohol.
Description

In laboratory animals, repeated cycles of abstinence from and return to alcohol drinking can lead to changes in alcohol intake. In a study of the effect of abstinence on drinking in humans, the investigators found evidence that abstinence affects drinking differently in women compared to men. In the present study, the investigators propose to study how men and women respond to abstinence, and whether this information can be used to improve intervention and prevention strategies.

COMPLETED
Social Effects of Alcohol
Description

In this study the investigator will assess the effect of a moderate dose of alcohol on emotional responses and feelings of connection during a dyadic semi-structured social interaction

RECRUITING
Enhancing the Effects of Alcohol Treatment With L-Carnitine
Description

The primary objective of this study is to evaluate the effects of L-carnitine, 2.97g daily on alcohol cue-elicited alcohol craving during a human laboratory paradigm after 4 weeks of daily dosing among participants ages 18-25 with alcohol use disorder (AUD) as confirmed by the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5™) and who report at least mild depressive symptoms on the Beck Depression Inventory-II. Secondary objectives include evaluation of L-carnitine (2.97g/day) on alcohol craving and use, subjective effects of alcohol consumption, mood, sleep, alcohol use negative consequences, study retention, and safety and tolerability.

RECRUITING
MPFC Theta Burst Stimulation as a Treatment Tool for Alcohol Use Disorder: Effects on Drinking and Incentive Salience
Description

The purpose of this study is to develop transcranial magnetic stimulation (TMS), specifically TMS at a frequency known as theta burst stimulation (TBS), to see how it affects the brain and changes the brain's response to alcohol-related pictures. TMS and TBS are stimulation techniques that use magnetic pulses to temporarily excite specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). TBS, which is a form of TMS, will be applied over the medial prefrontal cortex, (MPFC), which has been shown to be involved with drinking patterns and alcohol consumption. This study will test whether TBS can be used as an alternative tool to reduce the desire to use alcohol and reducing the brain's response to alcohol-related pictures.

COMPLETED
Alcohol-Containing Products' Effect on Breathalyzer Results in Healthy Adults Without Acute Intoxication
Description

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.

RECRUITING
Novel mGluR5 Modulator Effects on Alcohol Drinking and MRI Outcomes
Description

This study evaluates the effects of the medication GET73 among non-treatment-seeking individuals who regularly drink alcohol. Participants in the study will take GET73 or placebo for an 8-day study. There are 4 study visits including 2 MRI scans.

COMPLETED
Enhancing the Effects of Alcohol Treatment With Lamotrigine
Description

This study will help determine the tolerability and efficacy of the mood-stabilizing anticonvulsant lamotrigine in youth with alcohol use disorder. It will also help establish whether and how lamotrigine improves outcomes related to alcohol use. The results of this proof-of-concept study will inform whether a future larger clinical trial is warranted.

COMPLETED
Proximal Effects of Alcohol on Same-Sex Intimate Partner Violence
Description

We will recruit sexual and gender minority couples to complete 56 days of daily surveys in order to evaluate (1) the impact of COVID-19 stress and sexual and gender minority stress on heavy episodic drinking and intimate partner violence (IPV) perpetration, and (2) a brief, mobile-phone delivered text messaging intervention to mitigate the effects of these stressors. This project has high potential to inform how pandemic stress contributes to etiological models of alcohol-related IPV perpetration in sexual and gender minority couples and inform a culturally-sensitive, low burden, and easy to disseminate intervention to mitigate these effects critical during a pandemic when access to care is limited.

TERMINATED
Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers
Description

This is a double-blind, randomized, placebo-controlled, crossover design trial that will test the effect of pitolisant on alcohol self-administration and craving following a priming dose of alcohol. The specific objective of this proposal is to determine whether pitolisant has effects on alcohol consumption and craving

COMPLETED
Estradiol Effects on Alcohol Across the Menstrual Cycle
Description

This study will provide the first rigorous integrative test of the hypothesis that rapid rises in estradiol (a female hormone) increase the rewarding and disinhibiting effects of alcohol and that such increased sensitivity correlates with increased alcohol use. Identification of the behavioral mechanisms by which estradiol surges can increase alcohol use would provide a critical advancement of neurobiological theory of alcohol abuse in women, an understudied area, as well as provide new directions for personalization of alcohol abuse treatment in women. In this study, naturally-cycling women will be examined daily over their menstrual cycle using an integrative combination of daily ecological assessments of hormone fluctuations and alcohol use along with strategically-timed laboratory tests of their acute sensitivity to the rewarding and disinhibiting effects of a controlled dose of alcohol.

TERMINATED
Effects of Alcohol and Mood on Attention
Description

Acute use of alcohol is related to increased risk for suicide. However, our understanding of this problem is hindered by the lack of experimental tests of conditions underlying the alcohol use-suicide relationship. The attention allocation model (AAM) proposes that alcohol intoxication limits individuals' focus to salient cues in their environment. Thus, acute use of alcohol (AUA) during negative mood states may cause people to focus their attention towards suicide-related cues in their environment, thus increasing their risk for suicide while intoxicated. The proposed pilot study tests the AAM by exploring the combined effects of AUA, mood, and alcohol expectancies on attentional bias towards suicide-related cues. The proposed study will explore the combined impact of AUA and negative mood on attentional bias towards suicide in a sample of community adults. The investigators will further explore whether individual differences in alcohol expectancies influence these associations. The investigators will conduct a 2 by 2 (alcohol/placebo by negative mood/positive mood), between-subjects experiment involving alcohol administration, a well-established mood induction paradigm, and a performance-based dependent measure of attention towards suicide-related cues. The investigators expect that individuals in the negative mood-alcohol condition to show the greatest suicide-related attentional bias. The investigators expect that alcohol expectancies related to suicide will strengthen this association, and that positive mood alcohol expectancies will weaken this association. This pilot study will provide an initial test of the feasibility of this project and the hypotheses. This study will form the basis for a larger scale study able to test the effects.

Conditions
COMPLETED
Acute Neural and Immune Effects of Alcohol in People Living With HIV Infection
Description

This study will examine whether moderate alcohol use in the context of HIV infection exacerbates inflammatory signaling in the immune system and brain. The study will recruit healthy individuals and people living with HIV infection who are otherwise in good health to participate. Participants will complete an experimental protocol that involves controlled alcohol administration and magnetic resonance imaging (MRI). Primary outcomes are plasma biomarkers of inflammation and MRI markers correlated with neuroinflammation. Results will advance understanding of the effects of alcohol use in people living with HIV infection.

TERMINATED
Brief ROC Training Effects on Alcohol Drinking
Description

The goal of the proposed study is to examine whether a single session of training in regulation of craving (ROC-T) affects alcohol drinking. The study will consist of (1) a basic screening (phone and/or online) and an in-person visit, to determine eligibility and conduct pre-intervention baseline assessments; (2) a training (ROC-T) visit, (3) a post-intervention assessment visit, and (4) 1-2 phone/online follow-up assessments. The study will take up to 10 hours of the participants' time.

COMPLETED
The Effects of Alcohol Consumption on Central Adiposity
Description

The objective of the proposed study is to enroll women with obesity that will undergo a controlled, energy restricted feeding intervention to test the effects of chronic ethanol consumption on adipose distribution and circulating testosterone during weight loss.

COMPLETED
Physiological Study of the Efficacy and Mechanistic Effects of Alcohol Renal Denervation
Description

Hypertension is a major risk factor for heart disease and stroke, two of the leading causes of death in the United States. Hypertension is a common and widespread problem; unfortunately, current treatment strategies fail to adequately control blood pressure in up to 50% of patients either because of failure to take prescribed medications (because of cost, side effects, inconvenience etc.) or lack of therapeutic response. Indeed, it is estimated that 50% of patients stop taking antihypertensive medication within 6-12 months after the initiation of drug therapy. Despite enthusiasm for a novel approach called renal denercation, presently there are no integrative studies of the antihypertensive effect of renal denervation on the multiple regulatory pathways it may consequentially affect. Experimental evidence from pre-clinical models suggests the effects are due to reducing efferent sympathetic activity and thus lowering blood pressure by altering the renin-angiotensin system. Uncontrolled clinical studies in humans suggest that when effective, this procedure may also lower renal sympathetic nerve activity. However the sympathetic response to monopolar radiofrequency therapy has been highly variable. Moreover, there have been no assessments of procedural efficacy performed in humans. Thus the actual mechanism by which this type of procedure reduces BP in humans is largely unknown, making it extremely difficult to identify the appropriate patients for this invasive procedure. Recently, chemical renal denervation using ethanol (EtOH), was demonstrated to markedly lower blood pressure in small numbers of patients with resistant hypertension. However the mechanisms by which blood pressure is altered using this novel technique in humans is entirely unknown, and procedural efficacy has also not been assessed. Therefore it is unclear, whether in humans renal sympathetic nerve activity is lowered following renal denervation using this new approach. The Investigators propose to use high resolution physiological testing to determine the effects of chemical renal artery denervation on sympathetic activity. Therefore the global objective of this physiological study is to provide the first detailed assessment of the integrated mechanistic effects of chemical renal nerve denervation in humans with hypertension that is uncontrolled by conventional treatment (because of lack of adherence or response to therapy).

Conditions
COMPLETED
Acute Neuroimmune Effects of Alcohol Using Free Water Imaging
Description

This study examines the effects of moderate alcohol intake on the brain, the immune system, and cognition.

COMPLETED
30-to-90 Day Challenge: Effects of Alcohol Cessation on Health Outcomes
Description

The objective for this project is to determine whether how certain behavioral and health functions change in persons with heavy drinking when they stop (or reduce) drinking for 30 days, and whether changes continue for up to 90 days. The study will also identify barriers and facilitators related to drinking reduction. The project will focus on clinical comorbidities including HIV disease control, cognitive and brain function, liver abnormalities, and chronic inflammation. The study teams propose to enroll 140 HIV+ and 40 HIV- adults with heavy drinking, and then use Contingency Management (CM) with financial incentives to encourage participants to maximally reduce alcohol consumption for 30 days. Participants will be required to wear an ankle biosensor (SCRAM monitor) at all times, which is used to monitor participants' drinking behavior. At 30 days, participants will complete a full day of follow-up, including cognitive testing, neuroimaging, blood testing, liver Fibroscan, and questionnaires. Many participants will also provide a stool sample for gut microbiome assessment at each time point. At 30 days, participants will participate in a motivational interview to discuss perceived benefits and obstacles to drinking reduction, and most participants will continue CM to 90 days (but can opt out at this point). Participants will complete another full-day assessment at 90 days, at which point persons may choose to drink or not on their own (no more CM). A final assessment will be conducted at 12 months. This A-B-A design will enable us to clearly identify whether alcohol effects on cognition and brain function are reversible in the context of HIV, and analyze specific cerebral and systemic pathophysiological factors contributing to these effects. The inclusion of HIV- adults will enable subgroup comparisons of alcohol reduction effects in the context of HIV vs. no-HIV. These HIV-negative participants will be recruited from the same settings as our HIV+ participants, and will include a similar proportion by age, race, and gender as the HIV+ participants. The study team will use information from the MI data and our other assessments to elucidate factors that predict both short term (during CM) and long-term (1-year) alcohol reductions, and study how changes in alcohol consumption affect important HIV clinical outcomes that will be monitored over time.