Access to medication for opioid use disorder supported by telemedicine and healthcare coverage: A web-based survey during the COVID-19 pandemic.

Background and Aims: Medications for opioid use disorder (MOUD) are highly effective in improving treatment outcomes and reducing overdose. Concerns about interrupted access to critical MOUD services led to expansion of telemedicine services during the COVID-19 pandemic in the US. The current study tested the hypothesis that telemedicine usage and healthcare coverage would be significantly associated with access to MOUD in the early phase of the COVID-19 pandemic. Design: A cross-sectional online survey was administered to a non-probability sample from June 18-July 19, 2020 using the Amazon Mechanical Turk platform. Setting: Northeastern United States during the early phase of the COVID-19 pandemic. At the time of the survey, federal regulators had waived the longstanding requirement for in-office visits for MOUD prescription receipt and provided guidance on increasing third-party payer reimbursement rates for telehealth visits in order to mitigate barriers to care associated with COVID-19 safety guidelines. Participants: Individuals 18 years or older residing in Connecticut, Massachusetts, New Jersey, New York, or Rhode Island were eligible to complete the survey. The analytic sample was participants who reported using opioids not as prescribed by a physician in the past seven days. Measurements: Demographics, telemedicine usage, and healthcare coverage were assessed as explanatory variables. The primary outcome was whether participants reported ability to access MOUD in the past four weeks. Findings: In this sample of individuals who used illicit opioids in the past week (N = 191), one in two individuals who utilized telehealth or had healthcare coverage were able to access MOUD, whereas only one in five of their respective counterparts who did not have telehealth access or healthcare coverage were able to access these medications. Conclusions: Telemedicine and healthcare coverage were associated with greater MOUD access early in the COVID-19 pandemic, when barriers to care were high. Such findings speak to the importance of not only extending but also formalizing temporary policy changes instituted during the pandemic to allow MOUD prescribing via telemedicine.

Peer-elicited alcohol craving in adolescents and emerging adults: Bridging the laboratory and natural environment.

BACKGROUND: Although peers figure prominently in developmental models of alcohol use, our understanding of the influence of peer social context in cue reactivity paradigms with adolescents and emerging adults in the human laboratory and the natural environment is limited. This study tested associations between alcohol craving among youth in the human laboratory using alcohol-related images, with and without peers, and in the natural environment using ecological momentary assessment (EMA). METHODS: Data for this preregistered secondary analysis were collected prior to randomization in two medication trials (N = 115). Participants completed an image cue exposure paradigm at the baseline laboratory session followed by approximately 7 days of EMA. RESULTS: In the laboratory, model-based mean comparisons from multilevel models (MLMs) showed that all drinking images elicited greater craving than neutral images. No differences were observed across the three image categories containing alcohol. Image category by age interactions demonstrated that, compared to older youth, younger youth displayed lower craving in response to neutral versus social drinking context with peers images and older, compared to younger, youth displayed higher craving in response to nonsocial drinking images versus social drinking contexts with peers images. In the natural environment, craving was greatest when youth were in the presence of alcohol-using peers and alcohol-related cues, regardless of age. Laboratory craving to alcohol images was positively associated with craving in the natural environment. CONCLUSIONS: For youth, peers are a salient social context associated with increased craving, particularly in the natural environment. Laboratory cue reactivity to alcohol images predicted real-world craving, further supporting the ecological validity of this paradigm in youth.

The effects of race and class on community-level stigmatization of opioid use and policy preferences.

BACKGROUND: With opioid use and overdose rates continuing to plague minority communities in the U.S., we explored whether a geographic community's racial composition and social class affect how opioid use in the community is stigmatized and what policy preferences arise in response. METHODS: We use case vignettes in a randomized, between-subjects study (N = 1478) with a nation-wide survey. The vignettes describe a community where opioids are harmfully used, varying whether the community was (1) wealthy or poor, (2) predominantly Black or White and (3) facing prevalent use of painkillers or heroin. We tested how these variables affect public stigmatization of opioid use (measured with ratings of responsibility, dangerousness, sympathy, concern, anger, and disappointment) preferred levels of social distance from communities with opioid use (measured with responses to questions about living, working, and interacting in the community), and policy preferences for responding to opioid use (measured with levels of support for providing a safe-consumption site in the community, treating drug use in the community punitively, treating drug use in the community as an illness, and funding drug treatment in the community through income redistribution). RESULTS: Compared to wealthy communities with opioid use, poor communities with opioid use were less stigmatized in terms of responsibility, sympathy, concern, anger, and disappointment; they were also met with less support for punitiveness, more support for treating drug use as an illness, and preferences for greater social distance. Compared to White communities with opioid use, Black communities with opioid use were less stigmatized in terms of responsibility, and they were met with stronger preferences to not live and work there and with reduced support for using income redistribution to provide drug treatment for people in the community. Poor-Black communities with opioid use were also perceived to be more dangerous than both poor-White and wealthy-Black communities with opioid use. CONCLUSION: These results point to class- and race-based territorial stigma affecting how communities with opioid use are judged and whether policies for providing communities with treatment are supported.

Leveraging Ecological Momentary Assessment to Examine Bi-directional Associations Between Sleep Quality, Adolescent/Young Adult Alcohol Craving and Use.

BACKGROUND: Alcohol use is common among adolescents and young adults (AYA) and linked to poor sleep quality. Poor sleep quality may also increase alcohol use and alcohol craving, yet bi-directional relations between sleep quality and AYA alcohol use are poorly understood. PURPOSE: This study examined bi-directional associations between sleep quality, alcohol craving, and alcohol use in AYA using ecological momentary assessment (EMA) and explored if biological sex, age, or race moderated these associations. METHODS: This pre-registered secondary analysis pooled EMA data from the baseline, pre-randomization period (M = 8.18 days, range = 1-17) in two double-blind randomized placebo-controlled clinical trials examining medication effects on alcohol use in AYA (N = 115). Each morning, participants reported sleep quality and alcohol consumption (i.e., number of standard drinks) from the previous day, and craving was rated at several random points each day. RESULTS: Multilevel modeling showed that poorer average sleep quality was associated with higher levels of alcohol craving for females but not for males, and better overall levels of sleep quality were associated with decreased likelihood of engaging in alcohol use. No other person- or day-level associations between sleep and alcohol use emerged. CONCLUSIONS: Better sleep quality may be protective against alcohol use in AYA, and female AYA who report poorer sleep quality may experience higher levels of alcohol craving. Research and clinical assessment of AYA sleep quality can contribute to understanding of factors promoting alcohol craving and use.

This study explored how alcohol use among adolescents and young adults influences sleep quality as well as how sleep quality influences alcohol use and alcohol craving. Each morning, for approximately 1 week, participants reported their alcohol use from the prior day and their sleep quality from the prior night. They also rated their alcohol craving several times each day. Results showed that better overall sleep quality was associated with a lower likelihood of alcohol use. Poorer average sleep quality was associated with higher alcohol craving for females but not males. These findings suggest that better sleep quality may protect against alcohol use among youth and serve as a protective factor against alcohol craving for females.

COVID-19-Related Stressors and Clinical Mental Health Symptoms in a Northeast US Sample.

Research has linked specific COVID-19-related stressors to the mental health burden, yet most previous studies have examined only a limited number of stressors and have paid little attention to their clinical significance. This study tested the hypothesis that individuals who reported greater COVID-19-related stressors would be more likely to have elevated levels of anxiety, posttraumatic stress symptoms, and serious psychological distress. METHODS: An online survey was administered to a convenience sample from 18 June to 19 July 2020, in US states that were most affected by COVID-19 infections and deaths at the time. Individuals who were 18 or older and residents of five Northeast US states were eligible to participate (N = 1079). In preregistered analyses, we used logistic regression models to test the associations of COVID-19 stressors with symptoms on the Generalized Anxiety Disorder-7 (GAD-7), Impact of Event Scale-Revised, and K6, adjusting for sociodemographic covariates. RESULTS: COVID-19-related stressors (i.e., essential worker status, worry about COVID-19 infection, knowing someone hospitalized by COVID-19, having children under 14 at home, loneliness, barriers to environmental rewards, food insecurity, loss of employment) were associated with meeting thresholds (i.e., positive screening) for anxiety, posttraumatic stress, and/or serious psychological distress. Loneliness and barriers to environmental rewards were associated with all mental health outcomes. LIMITATIONS: We used a non-probability sample and cannot assume temporal precedence of stressors with regard to development of mental health symptoms. CONCLUSIONS: These findings link specific stressors to the mental health burden of the COVID-19 pandemic.

Discharge locations after hospitalizations involving opioid use disorder among medicare beneficiaries.

BACKGROUND: Hospitalizations involving opioid use disorder (OUD) have been increasing among Medicare beneficiaries of all ages. With rising OUD-related acute care use comes the need to understand where post-acute care is provided and the capacities for OUD treatment in those settings. Our objective was to describe hospitalized Medicare beneficiaries with OUD, their post-acute care locations, and all-cause mortality and readmissions stratified by post-acute care location. METHODS: We conducted a retrospective cohort study of acute hospitalizations using 2016-2018 Medicare Provider Analysis and Review (MedPAR) files linked to Medicare enrollment data and the Residential History File (RHF) for 100% of Medicare fee-for-service beneficiaries. The RHF which provides a person-level chronological history of health service utilization and locations of care was used to identify hospital discharge locations. We used ICD-10 codes for opioid dependence or "abuse" to identify OUD diagnoses from the MedPAR file. We conducted logistic regression to identify factors associated with discharge to an institutional setting versus home adjusting for demographics, comorbidities, and hospital stay characteristics. RESULTS: Our analysis included 459,763 hospitalized patients with OUD. Of these, patients aged < 65 years and those dually enrolled in Medicaid comprised the majority (59.1%). OUD and opioid overdose were primary diagnoses in 14.3% and 6.2% of analyzed hospitalizations, respectively. We found that 70.3% of hospitalized patients with OUD were discharged home, 15.8% to a skilled nursing facility (SNF), 9.6% to a non-SNF institutional facility, 2.5% home with home health services, and 1.8% died in-hospital. Within 30 days of hospital discharge, rates of readmissions and mortality were 29.7% and 3.9%; respectively, with wide variation across post-acute locations. Factors associated with greater odds of discharge to institutional settings were older age, female sex, non-Hispanic White race and ethnicity, dual enrollment, longer hospital stay, more comorbidities, intensive care use, surgery, and primary diagnoses including opioid or other drug overdoses, fractures, and septicemia. CONCLUSIONS: More than one-quarter (25.8%) of hospitalized Medicare beneficiaries with OUD received post-acute care in a setting other than home. High rates and wide variation in all-cause readmissions and mortality within 30 days post-discharge emphasize the need for improved post-acute care for people with OUD.

Associations between alcohol and cannabis use before and during the COVID-19 pandemic: Results of a community survey.

The COVID-19 pandemic has impacted individuals around the world, creating unprecedented challenges. Due to lockdowns and social distancing measures, many people have turned to contactless modes of obtaining alcohol and other substances (e.g., home delivery). This study investigated associations between alcohol and cannabis use before and during the initial months of the COVID-19 pandemic and factors associated with use. An online, cross-sectional survey with a non-probability sample (N = 1126) was conducted in Northeast states during June-July 2020. Outcomes examined prevalence of alcohol and cannabis use for the overall sample and predictors of use in individuals who used substances. In the overall sample, we found that alcohol and cannabis use decreased from before to during the pandemic. For individuals who drank alcohol, higher pre-pandemic drinking, mid-range household income, and obtaining alcohol through home delivery were associated with higher alcohol drinking during the pandemic. For individuals who used cannabis, higher pre-pandemic cannabis use and obtaining cannabis through home delivery were associated with higher cannabis use during the pandemic. Overall, from before to during the pandemic, we found a decrease in the proportion of individuals who used substances and no changes in quantity for individuals who continued to use substances. Home delivery was associated with greater use of alcohol and marijuana, supporting a need for further research on risk factors for heavier substance use.

The impact of race, gender, and heroin use on opioid addiction stigma.

INTRODUCTION: Stigmatization of an opioid addiction acts as a barrier to those seeking substance use treatment. As opioid use and overdoses continue to rise and affect minority populations, understanding the impact that race and other identities have on stigma is pertinent. METHODS: This study aimed to examine the degree to which race and other identity markers (i.e., gender and type of opioid used) interact and drive the stigmatization of an opioid addiction. To assess public perceptions of stigma, this research team conducted a randomized, between-subjects case vignette study (N = 1833) with a nation-wide survey. Participants rated a hypothetical individual who became addicted to opioids on four stigma indices (responsibility, dangerousness, positive affect, and negative affect) based on race (White or Black), gender (male or female), and end point (an individual who transitioned to using heroin or who continued using prescription painkillers). RESULTS: Our results first showed that the White individual had higher stigma ratings compared to the Black individual (range of partial η2 = 0.002-0.004). An interaction effect demonstrated that a White female was rated with higher responsibility for opioid use than a Black female (Cohen's d = 0.21) and a Black male was rated with higher responsibility for opioid use than a Black female (Cohen's d = 0.26). Last, we showed that a male and an individual who transitioned to heroin had higher stigma than a female and an individual who continued to use prescription opioids (range of partial η2 = 0.004-0.007). CONCLUSION: This study provides evidence that information about multiple identities can impact stigmatizing attitudes, which can provide deeper knowledge on the development of health inequities for individuals with an opioid addiction.

Behavioral economic analysis of topiramate pharmacotherapy for alcohol: a placebo-controlled investigation of effects on alcohol reinforcing value and delayed reward discounting.

RATIONALE: Pharmacotherapies are an important clinical strategy for treating alcohol use disorder and an understanding of their functional mechanisms can inform optimal use. Behavioral economics provides a translational platform that may advance our understanding of the motivational impacts of pharmacotherapies. OBJECTIVES: This secondary analysis study examined the effect of topiramate, a promising pharmacotherapy for treating alcohol use disorder, on two behavioral economic domains, the reinforcing value of alcohol (alcohol demand and alcohol-specific monetary expenditures) and delayed reward discounting (preference for smaller immediate rewards over larger delayed rewards). METHODS: A double-blind randomized placebo-controlled study (n = 99) was conducted with non-treatment seeking heavy drinkers, comparing topiramate (target dose of 200 mg/day titrated for 3 weeks and remained at the target dose for 2 weeks) to matched placebo. RESULTS: We found that compared to placebo, topiramate reduced the reinforcing value of alcohol, as shown by a reduction in two alcohol demand indices (intensity and Omax), money spent per week on alcohol and an almost a 50% increase in days without expenditures on alcohol from baseline. Directionally consistent patterns were also present for breakpoint and elasticity (ps = .08). No significant effects were found for delayed reward discounting. CONCLUSIONS: This study provides evidence that topiramate reduces alcohol's reinforcing value as measured by alcohol demand and alcohol expenditure. More broadly, these findings support the utility of behavioral economics for understanding how medications reduce alcohol use.

Alcohol-related changes in behaviors and characteristics from the baseline to the randomization session for treatment and non-treatment seeking participants with alcohol use disorder.

BACKGROUND: Participants who are enrolled in randomized controlled trials (RCTs) may be more motivated to change their behaviors after being enrolled in a study and that motivation may vary by treatment status. OBJECTIVES: The objectives of this secondary analysis were to investigate if changes in alcohol-related behaviors/characteristics from the baseline to the randomization session differed overall and to assess those differences between non-treatment and treatment seeking individuals with alcohol use disorder (AUD). METHODS: Our sample included participants from eight RCTs conducted at Brown University (N = 281, 34% female). To assess differences across alcohol-related behaviors/characteristics, we investigated changes in craving (obsessive compulsive drinking scale) and alcohol drinking (percent abstinent days, drinks per week (DPW) and percent heavy drinking days (HDD)) overall and between treatment status. RESULTS: Results showed that there were baseline differences, such as increased AUD severity and craving for alcohol in treatment seeking participants (p's < .05) in the overall sample. Next, we showed that craving, DPW and HDD decreased and percent abstinent days increased from baseline to randomization (p's < .05). When controlling for treatment status and sociodemographic characteristics, treatment seeking, compared to non-treatment seeking participants, had a greater reduction in alcohol craving (p < .001) and a greater increase in percentage of drinking days (p < .01). CONCLUSIONS: These findings demonstrated that alcohol-related behaviors and characteristics changed after enrollment. Severity, craving and drinking behaviors also differed between treatment-seeking status, which can potentially impact medication development stages for AUD such as clinical trial eligibility, enrollment and study outcomes.

Stigma and policy preference toward individuals who transition from prescription opioids to heroin.

BACKGROUND: There is a lack of understanding of what contributes to attitudes toward individuals with an opioid addiction and preferences for policies that support them. METHODS: This study aimed to investigate stigmatization of an opioid addiction and support for publicly funded drug treatment. A randomized, between-subjects case vignette study (N = 1998) was conducted with a nation-wide online survey. To assess public perceptions of stigma and support for publicly funded drug treatment, participants rated a hypothetical individual who became addicted to prescription opioids across three conditions: 1) male or female, 2) an individual who was prescribed prescription painkillers or took prescription painkillers from a friend and 3) an individual who transitioned to using heroin or who continued using prescription painkillers. RESULTS: Our results showed that there were stronger negative attitudes towards a male (p < .01) and toward an individual who took prescription painkillers from a friend (all p's < .05), and both stronger positive and negative attitudes toward an individual who transitioned to heroin from prescription painkillers (all p's < .05). Next, we demonstrated that the probability that someone supports publicly funded drug treatment increases by 3.6 percentage points for each unit increase along a 12-point scale of positive attitudes (p < .0005), 1.3 percentage points for each unit decrease along a 12-point scale of negative attitudes (p < .005), 7.3 percentage points for each unit increase along a 6-point scale of perceived treatment efficacy (p < .0001), 0.1 percentage points for each unit decrease along a 100-point scale that measures the strength of one's belief that addiction is controllable (p < .005) and 0.2 percentage points for each unit decrease along a 100-point scale that measures the strength of one's belief that income is controllable (p < .005). Lastly, when controlling for the effects of stigma, the probability of supporting publicly funded drug treatment decreases by 6.3 percentage points (p < 0.001) when an individual was prescribed prescription painkillers from a doctor. However, path analysis identified a channel through which a doctor's prescription increased support for publicly funded drug treatment by influencing positive attitudes, negative attitudes, and responsibility. CONCLUSION: Our findings provide further evidence that information about individuals who become addicted to opioids can influence stigma perceptions and support for publicly funded drug treatment.

Sociodemographic Characteristics and the Stigmatization of Prescription Opioid Addiction.

OBJECTIVES: The aim of this study was to investigate the relationship between participants' sociodemographic characteristics and the degree to which they stigmatize people with an opioid addiction. METHODS: A randomized, between-subjects case vignette study (n = 2605) was conducted with a nationwide online survey. We investigated how the stigmatization toward a hypothetical individual who misused prescription opioids differed across participants' sociodemographic factors (ie, age, gender, education, race, and income). RESULTS: Our results showed that study participants who were male, white, low-income, college graduates, and younger rated the hypothetical individual with an opioid addiction with lower stigma. In addition, we showed that participant gender moderated the relationship between information given about initiation of opioid use (received prescription opioids from a doctor vs took prescription opioids from a friend) and opioid stigma perceptions. CONCLUSIONS: Our results support previous findings that stigmatizing attitudes towards drug use vary across participant sociodemographic characteristics. The findings from our study provide a better understanding of how stigmatizing attitudes towards prescription opioid use differ across sociodemographic characteristics and can serve to improve negative perceptions of those with an opioid addiction.

Opioid Craving in Human Laboratory Settings: a Review of the Challenges and Limitations.

There are many factors that need to be taken into consideration when measuring craving in a human laboratory study. This review summarizes and discusses some of the major challenges researchers are faced with when assessing opioid craving in clinical research. First, there are wide range of available assessments that have been developed for measuring craving and depending on the research questions or the underlying constructs targeted, some may be more appropriate than others. In addition to establishing the methodological point of departure for designing a study with craving, there are also different participant conditions and characteristics that need to be evaluated when selecting among the large selection of assessments available. Participant conditions/characteristics can influence the degree or frequency of opioid craving experienced. Lastly, there can be contextual conditions that affect opioid cravings such as a stressful environment that may alter cue saliency. It is recommended that researchers carefully consider the different constituents that contribute to opioid craving and to ensure a comprehensive evaluation when assessing each participant. A more thorough consideration of these challenges can help us to understand the optimal ways to measure one important and complex component of addiction.

Multisensory Environments to Measure Craving During Functional Magnetic Resonance Imaging.

There are limited functional magnetic resonance imaging (fMRI) studies that measure alcohol craving with multisensory environments. Researchers are faced with a two-fold challenge: to recreate a naturalistic environment during an MRI scan and to produce paradigms that mimic real-life conditions involved with craving. Craving is a multifaceted psychological construct and techniques such as fMRI provide an alternative way to measure craving and to have a better understanding of its complexity. Most studies to date have implemented visual stimuli to measure craving and only a few studies have investigated gustation and olfaction. Moving forward, there needs to be greater attention on the ways in which we measure craving and the use of multisensory environments during fMRI. By going beyond examining subjective craving responses, and investigating neurobiological responses such as brain activity during fMRI, can potentially lead to better treatments for alcohol use disorder. Further, there needs to be additional consideration on standardizing how we measure craving, which will allow for a more unified approach amongst researchers.

Waking Up from Dreamland: Opioid Addiction Precipitance and Support for Redistributive Drug Treatment.

Motivated by the historical components of the ongoing U.S. opioid epidemic, this study examines how public support for redistributive drug treatment changes with awareness that someone's opioid addiction started with a legally acquired prescription. Using different versions of a vignette, we vary in a randomized design whether someone's addiction to painkillers started with a legally acquired prescription or with the decision to take pills from a friend. After reading the vignette, participants expressed their level of support for a policy that uses income redistribution to fund a program that provides the person in the vignette with drug treatment. We find that participants are less likely to support redistributive drug treatment when a prescription precipitates the addiction. The results imply that emphasizing the medical establishment's role in the opioid epidemic may actually make people less likely to favor using redistributive drug treatment to provide support.

Opioid use and stigma: The role of gender, language and precipitating events.

The stigma of drug addiction is associated with negative perceptions and can be a barrier to treatment. With the rise in opioid overdose deaths, understanding stigmatizing attitudes towards individuals who use opioids is a crucial matter. There is a lack of opioid use research on stigma and, therefore, we aimed to discern stigmatizing attitudes towards people with opioid addiction. A randomized, between-subjects case vignette study (n = 2605) was conducted with a nation-wide online survey. Participants rated a hypothetical individual addicted to opioids on different dimensions of stigma after seeing one version of a vignette that varied by three conditions: 1) a male versus a female, 2) an individual labeled as being a "drug addict" versus having an "opioid use disorder" and 3) an individual whose use started by taking prescription opioids from a friend versus receiving a prescription from a doctor. Our results indicated that there were higher stigmatizing attitudes overall towards a male, an individual labeled as a "drug addict" and an individual who took prescription opioids from a friend. Interaction effects also showed that a female labeled with an "opioid use disorder" and male labeled as a "drug addict" were rated with higher stigma. The findings from our study are the first to show that information about gender, precipitating events and language matter when assessing stigma and opioid use and may affect the delivery of patient care.

Administration of the metabotropic glutamate receptor subtype 5 allosteric modulator GET 73 with alcohol: A translational study in rats and humans.

Preclinical work suggests that GET 73 (N-[4-(trifluoromethyl)benzyl]-4-methoxybutyramide), a novel metabotropic glutamate receptor subtype 5 negative allosteric modulator, may represent a novel pharmacological treatment for alcohol use disorder. Two independent experiments evaluated the effect of acutely administered GET 73 (0, 30, and 100 mg/kg, intragastrically) on alcohol-induced hypolocomotion ( n=72) and sedation/hypnosis ( n=36) in rats. In healthy male volunteers ( n=14), an open-label, randomised, crossover study was conducted to compare adverse events and pharmacokinetic parameters, in two experiments in which 300 mg GET 73 was administered, with and without alcohol, once and thrice. In rats, when administered with alcohol-vehicle, 100 mg/kg, but not 30 mg/kg, GET 73 reduced spontaneous locomotor activity. When administered with alcohol, no dose of GET 73 altered either alcohol-induced hypolocomotion or sedation/hypnosis. In humans, both single and thrice 300 mg GET 73 administration were well tolerated, in the presence and absence of alcohol, with no differences in adverse events. There were no significant differences in relative bioavailability between administering 300 mg GET 73 in the presence or absence of alcohol.

Comparing and Combining Topiramate and Aripiprazole on Alcohol-Related Outcomes in a Human Laboratory Study.

AIMS: The goal of this study was to evaluate the efficacy of topiramate up to 200 mg/day and of aripiprazole up to 15 mg/day, alone and combined, in reducing alcohol-related outcomes in a human laboratory study. METHOD: This was a 5 week, between-subject, double-blind, placebo-controlled human laboratory study with topiramate [0 mg/day (placebo), 100 mg/day, 200 mg/day] and aripiprazole [0 mg/day (placebo), 7.5 mg/day, 15 mg/day] in 90 non-treatment seeking, heavy drinking, alcohol-dependent individuals. Main outcomes were the efficacy of 200 mg/day topiramate and 15 mg/day aripiprazole, alone and combined, in reducing drinks consumed during an alcohol self-administration procedure (human laboratory phase) and while receiving the study medications prior to the laboratory session (naturalistic drinking phase). Other outcomes in the laboratory phase included alcohol craving, and alcohol biphasic effects. RESULTS: In the human laboratory phase, topiramate 200 mg/day reduced alcohol craving [**P < 0.01] and amplified alcohol-induced stimulation [*P < 0.05], but did not reduce the number of drinks consumed. Topiramate 200 mg/day was also effective in reducing drinking days [*P < 0.05], and alcohol craving [*P < 0.05], in the naturalistic drinking phase. No significant findings were found for aripiprazole for any of the outcomes analyzed. CONCLUSION: Participants receiving 200 mg/day topiramate reported reduced alcohol drinking and craving, and increased alcohol-related stimulation. These findings provide further support for the role of topiramate as a pharmacological treatment for AUD. CLINICALTRIAL.GOV IDENTIFIER: NCT00884884. SHORT SUMMARY: This study tested topiramate and aripiprazole alone and in combination. The results replicate past findings and suggest that topiramate may be an effective treatment for alcohol use disorder. The present results suggest that the combination of topiramate and aripiprazole do not warrant further evaluation.

Dataset for Phase I randomized clinical trial for safety and tolerability of GET 73 in single and repeated ascending doses including preliminary pharmacokinetic parameters.

The data in this article outline the methods used for the administration of GET 73 in the first time-in-human manuscript entitled "Phase I randomized clinical trial for the safety, tolerability and preliminary pharmacokinetics of the mGluR5 negative allosteric modulator GET 73 following single and repeated doses in healthy male volunteers" (Haass-Koffler et al., 2017) [1]. Data sets are provided in two different manners. The first series of tables provided includes procedural information about the experiments conducted. The next series of tables provided includes Pharmacokinetic (PK) parameters for GET 73 and its main metabolite MET 2. This set of data is comprised by two experiments: Experiment 1 references a single ascending dose administration of GET 73 and Experiment 2 references a repeated ascending dose administration of GET 73.