Kara Manning, Michael J Zvolensky, Matthew W Gallagher, Candice Alfano, Andres G Viana, Janice A Blalock
{"title":"Understanding fatigue severity and smoking deprivation in smoking behavior and urges: A pilot test.","authors":"Kara Manning, Michael J Zvolensky, Matthew W Gallagher, Candice Alfano, Andres G Viana, Janice A Blalock","doi":"10.1037/pha0000773","DOIUrl":"https://doi.org/10.1037/pha0000773","url":null,"abstract":"<p><p>Smoking prevalence in the United States has stabilized as the remaining population becomes increasingly representative of \"at-risk smokers\" who are unable to quit. The experience of severe fatigue may be one underrecognized but highly common problem that may help in understanding smoking maintenance and relapse. Yet, there has been no research on fatigue severity in relation to smoking behavior measured in \"real time.\" The purpose of the present study was to provide a pilot test of fatigue severity in the context of smoking deprivation in predicting number of puffs, puff velocity, interpuff interval, and smoking urges during an experimental relapse analogue task. Participants in the present study included 36 (<i>M</i>age = 49.25 years, <i>SD</i> = 8.83; 54.1% male) daily cigarette smokers who reported prolonged fatigue. Results indicated that there was a statistically significant interactive effect between smoking deprivation and fatigue severity in the prediction of interpuff interval, such that those with greater fatigue severity, when smoking deprived, evinced greater time between puffs. Other analyses documented meaningful effect sizes for fatigue severity, but due to the sample size, results were generally not statistically significant. This pilot test found some empirical evidence for the continued study of fatigue severity as an individual difference factor relevant to smoking maintenance and relapse in an experimental context. (PsycInfo Database Record (c) 2025 APA, all rights reserved).</p>","PeriodicalId":12089,"journal":{"name":"Experimental and clinical psychopharmacology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143566379","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rafaela M Fontes, Ana Carolina L Bovo, Roberta Freitas-Lemos, Warren K Bickel
{"title":"Differential discounting of past and future gains and losses in individuals in recovery from substance use disorder.","authors":"Rafaela M Fontes, Ana Carolina L Bovo, Roberta Freitas-Lemos, Warren K Bickel","doi":"10.1037/pha0000769","DOIUrl":"https://doi.org/10.1037/pha0000769","url":null,"abstract":"<p><p>Individuals with substance use disorder (SUD) show consistently higher delay discounting (DD) rates than controls for both future and past outcomes, as well as for gains and losses. However, differences in these DD effects (e.g., tense and sign) among individuals in SUD recovery have yet to be explored. Therefore, the goal of the present study was to (a) investigate differences in discounting of past and future gains and losses among individuals in SUD recovery and (b) examine differences in these DD effects between individuals in different stages of remission (i.e., not in remission, in early remission, or in sustained remission). Our results indicate that individuals in recovery discount past and future gains, but not losses, symmetrically. Additionally, individuals in recovery discount gains more than losses (i.e., sign effect) for the future but not for the past. Finally, those in sustained remission showed significantly lower DD rates than those not in remission, regardless of the DD task. Thus, other discounting tasks might provide a similarly accurate measure of DD and can be employed to assess differences in discounting between those in remission and those not in remission. (PsycInfo Database Record (c) 2025 APA, all rights reserved).</p>","PeriodicalId":12089,"journal":{"name":"Experimental and clinical psychopharmacology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540692","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Shihui Huang, Sydney E Cerveny, Anna L Ruprecht, Ethan R Steere, Anushka Valsan, Anthony L Riley
{"title":"Chronic morphine impairs interoceptive control of avoidance: Implications for dysregulated drug intake.","authors":"Shihui Huang, Sydney E Cerveny, Anna L Ruprecht, Ethan R Steere, Anushka Valsan, Anthony L Riley","doi":"10.1037/pha0000762","DOIUrl":"https://doi.org/10.1037/pha0000762","url":null,"abstract":"<p><p>Interoceptive drug states have been increasingly recognized as important cues that may help regulate intake by disambiguating postintake outcomes. While drug states signaling rewarding or reinforcing effects may occasion drug-taking and drug-seeking, states signaling aversive effects may be critical for terminating a drug-taking episode. Given that drug intake often becomes dysregulated with extensive exposure, the present study investigated whether chronic drug exposure impairs the function of interoceptive drug states to occasion avoidance. Male Sprague Dawley rats were trained in a discriminated taste avoidance procedure in which morphine (10 mg/kg, intraperitoneally) signaled that a saccharin solution would be followed by the illness-inducing agent lithium chloride, while the drug vehicle signaled that saccharin would not be followed by lithium chloride. Rats were then exposed to chronic morphine (CM) or chronic vehicle for 20 days. Morphine-induced stimulus control was tested at three doses (0, 5, and 10 mg/kg) following chronic exposure and a 3-week morphine-free period (dissipation of tolerance). Forty-five of the 49 rats acquired the discrimination, avoiding saccharin when it was preceded by morphine and consuming saccharin when it was preceded by saline. Chronic vehicle-exposed rats displayed dose-dependent avoidance on a subsequent test, while CM-exposed rats displayed no avoidance at any dose. Following a 30-day washout during which morphine was no longer administered, subjects in group CM injected with 10 mg/kg morphine avoided saccharin, displaying a partial recovery of discriminative control. These findings provide a baseline for the attenuating effects of chronic drug exposure on the drug's interoceptive control of avoidance. Further, by demonstrating that interoceptive control recovers after abstinence, the results suggest that tolerance may contribute to such impairment. (PsycInfo Database Record (c) 2025 APA, all rights reserved).</p>","PeriodicalId":12089,"journal":{"name":"Experimental and clinical psychopharmacology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143523004","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mark J Rzeszutek, Sean D Regnier, Christopher T Franck, Mikhail N Koffarnus
{"title":"Overviewing the exponential model of demand and introducing a simplification that solves issues of span, scale, and zeros.","authors":"Mark J Rzeszutek, Sean D Regnier, Christopher T Franck, Mikhail N Koffarnus","doi":"10.1037/pha0000754","DOIUrl":"https://doi.org/10.1037/pha0000754","url":null,"abstract":"<p><p>One of the most successful models of describing the decay in commodity consumption as a function of cost across multiple domains is the exponential model introduced by Hursh and Silberberg (2008). This model formulates the value of a commodity by including a \"standardized price\" adjustment. This adjustment allows for a theoretically scale-invariant parameter to estimate a normalized decay (α, the sensitivity to changes in price) in commodity consumption that was detangled from an organism's consumption when a commodity is free (<i>Q</i>₀). This scale-invariant parameter is sometimes referred to as the <i>essential value (EV)</i>, which is generally represented as the inverse of α. However, the Hursh and Silberberg (HS) model has various shortcomings, notably as a result of the span parameter k and its influence on interpretations of α and, therefore, of essential value. We present an overview of the standardized price/real cost adjustment and challenges of and potential remedies to <i>k</i> within the HS framework and propose a simplified exponential model with normalized decay (Equation 10). The simplified exponential equation does not include the span parameter k and allows for straightforward analytic solutions for conceptually relevant and common demand metrics. Parities between the Hursh and Silberberg model and the simplified exponential with normalized decay model are demonstrated by conversions of α values between both models. Statistical parities between the simplified exponential with normalized decay model and the exponentiated model of demand with multiple data sets are also demonstrated. This simplified model then allows for consistent interpretations of α across commodities while retaining the theoretical benefits of the Hursh and Silberberg formulation of demand and the essential value. (PsycInfo Database Record (c) 2025 APA, all rights reserved).</p>","PeriodicalId":12089,"journal":{"name":"Experimental and clinical psychopharmacology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143522795","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ty S Schepis, Philip T Veliz, Vita V McCabe, Kennedy S Werner, Emily Pasman, Timothy E Wilens, Sean Esteban McCabe
{"title":"Severity of stimulant use disorder by psychostimulant type and polystimulant use pattern.","authors":"Ty S Schepis, Philip T Veliz, Vita V McCabe, Kennedy S Werner, Emily Pasman, Timothy E Wilens, Sean Esteban McCabe","doi":"10.1037/pha0000761","DOIUrl":"https://doi.org/10.1037/pha0000761","url":null,"abstract":"<p><p>Psychostimulant misuse and use disorders are major drivers of morbidity and fatal overdose in the United States, but little is known about how differences in psychostimulant use patterns relate to <i>Diagnostic and Statistical Manual, Diagnostic and Statistical Manual of</i> <i>Mental Disorders, 4th edition and Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)</i> stimulant substance use disorder (SUD) profiles. We used nationally representative U.S. data to assess the links between polystimulant use patterns and stimulant SUD prevalence, symptom counts, and <i>DSM-5</i> stimulant SUD severity. Data were from the 2015-2019 and 2020 National Survey on Drug Use and Health. Participants (<i>n</i> = 282,786) were grouped by past-year psychostimulant use patterns: (a) nonmedical use of prescription stimulants (NUPS) only; (b) cocaine-only; (c) methamphetamine-only; and (d) polystimulant use. Analyses comparing groups used logistic regressions for prevalence of past-year <i>Diagnostic and Statistical Manual of Mental Disorders, 4th edition</i> (2015-2019 and 2020) and <i>DSM-5</i> (2020 only) stimulant SUD, negative binomial regressions for stimulant SUD symptom counts, and multinomial regressions for DSM-5 stimulant SUD severity. Those with past-year methamphetamine-only or polystimulant use had significantly higher <i>Diagnostic and Statistical Manual of Mental Disorders, 4th edition</i> and <i>DSM-5</i> prevalence rates, symptom counts, and DSM-5 severities of stimulant SUD than those with NUPS or cocaine use only. Depending on <i>Diagnostic and Statistical Manual of Mental Disorders</i> version, 34%-47% of those engaged in polystimulant use and 48%-54% of those with methamphetamine use only met criteria for a stimulant SUD, versus 9%-17% for NUPS-only and 16%-24% for cocaine-only. For 2020, roughly two thirds of those with methamphetamine-only use had stimulant SUD symptoms. Individuals with methamphetamine and/or polystimulant use may have different service needs than those with NUPS or cocaine use only. (PsycInfo Database Record (c) 2025 APA, all rights reserved).</p>","PeriodicalId":12089,"journal":{"name":"Experimental and clinical psychopharmacology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143522812","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Amy M Cohn, Hoda Elmasry, Taylor Niznik, Wallace Pickworth, Michael A Smith, Whitney D Margaritis, Riley Wyatt, Delaney Dunn, Donald Hedeker, James Murphy, Janet Audrain-McGovern, Andrea C Villanti
{"title":"Racial and ethnic differences in topography and subjective effects among young adults in response to smoking their usual brand menthol or nonmenthol cigarette.","authors":"Amy M Cohn, Hoda Elmasry, Taylor Niznik, Wallace Pickworth, Michael A Smith, Whitney D Margaritis, Riley Wyatt, Delaney Dunn, Donald Hedeker, James Murphy, Janet Audrain-McGovern, Andrea C Villanti","doi":"10.1037/pha0000765","DOIUrl":"https://doi.org/10.1037/pha0000765","url":null,"abstract":"<p><p>Menthol smoking, which is popular among Black and Hispanic individuals who smoke and young adults, is linked to positive subjective effects and difficulty quitting, although studies of topography and subjective effects show inconsistent differences. This study compared subjective effects and laboratory smoking across menthol and nonmenthol young adults who smoke and examined differences by race/ethnicity. Smoking topography, subjective effects, and pre/postsmoking craving, vitals, cigarette weight, and exhaled carbon monoxide were assessed in 121 young adults who smoke (<i>M</i><sub>age</sub> = 23.9; 49.5% menthol; 37.2% non-White) following ≥12 hr of abstinence. Participants smoked their usual brand cigarette (menthol or nonmenthol) in a single laboratory session. Differences in study outcomes were examined across cigarette flavor and by race/ethnicity (White vs. non-White). No main effects of cigarette flavor or race/ethnicity emerged on any study outcomes. Interactions of cigarette flavor with race/ethnicity emerged on postsmoking craving and cigarette weight, controlling for presmoking measures of the outcome and cigarettes per day. Compared to non-White participants who smoked nonmenthol cigarettes, non-White participants who smoked menthol cigarettes had higher postsmoking cigarette weight and lower postsmoking craving. Further, non-White participants who smoked menthol cigarettes had lower postsmoking craving compared to White participants who smoked menthol cigarettes. Non-White young adults who smoke menthols experienced greater craving reduction, despite consuming less of their preferred cigarette. Craving reduction may be one mechanism fostering continued menthol smoking. Menthol smoking, even at lower amounts, produces similar toxicant exposure, which may contribute to tobacco health disparities as smoking progresses. (PsycInfo Database Record (c) 2025 APA, all rights reserved).</p>","PeriodicalId":12089,"journal":{"name":"Experimental and clinical psychopharmacology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143491298","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dan Petrovitch, Katie P Himes, Emma Quarles, Caroline E Freiermuth, Robert S Braun, Joshua W Lambert, Jennifer L Brown, Michael S Lyons, Brittany E Punches, Jon E Sprague, Andrew K Littlefield
{"title":"Negative urgency accounts for associations between internalizing symptoms and lifetime nonfatal opioid overdose among patients from three urban Ohio emergency departments.","authors":"Dan Petrovitch, Katie P Himes, Emma Quarles, Caroline E Freiermuth, Robert S Braun, Joshua W Lambert, Jennifer L Brown, Michael S Lyons, Brittany E Punches, Jon E Sprague, Andrew K Littlefield","doi":"10.1037/pha0000764","DOIUrl":"https://doi.org/10.1037/pha0000764","url":null,"abstract":"<p><p>Existing evidence relates internalizing psychopathology to nonfatal opioid overdose. Identifying variables that account for associations between internalizing symptomology and overdose could improve clinical conceptualizations of overdose risk and inform testable, mechanistic hypotheses. Mood-based facets of impulsivity, such as negative and positive urgency, are promising candidate variables that have been linked to both internalizing symptoms and negative substance use outcomes. Therefore, the present study tested whether these facets accounted for internalizing-overdose associations. We conducted a secondary, cross-sectional data analysis of lifetime opioid-exposed patients presenting to three large, urban emergency departments in Ohio. Bivariate associations between measures of internalizing conditions, mood-related urgency, and nonfatal opioid overdose were calculated, and the extent to which negative and positive urgency accounted for associations between internalizing constructs and nonfatal opioid overdose was examined. To determine the specificity of findings, we compared results to other impulsivity facets and models testing internalizing-impulsivity interactions. Negative urgency demonstrated a unique role in accounting for relationships between internalizing constructs and lifetime nonfatal opioid overdose. No other impulsivity facet, including positive urgency, reliably accounted for internalizing-overdose relations. No internalizing-urgency interactions were observed. Negative urgency was the only facet to reliably explain overlap in internalizing-overdose associations. Overdose-prevention efforts should consider the dual roles of internalizing symptoms and negative urgency as risk factors for opioid overdose. Implications for testing causal hypotheses are discussed. (PsycInfo Database Record (c) 2025 APA, all rights reserved).</p>","PeriodicalId":12089,"journal":{"name":"Experimental and clinical psychopharmacology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143491370","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Shawn P Gilroy, Mark J Rzeszutek, Mikhail N Koffarnus, Derek D Reed, Steven R Hursh
{"title":"Adaptive purchase tasks in the operant demand framework.","authors":"Shawn P Gilroy, Mark J Rzeszutek, Mikhail N Koffarnus, Derek D Reed, Steven R Hursh","doi":"10.1037/pha0000757","DOIUrl":"https://doi.org/10.1037/pha0000757","url":null,"abstract":"<p><p>Various avenues exist for quantifying the effects of reinforcers on behavior. Numerous nonlinear models derived from the framework of Hursh and Silberberg (2008) are often applied to elucidate key metrics in the operant demand framework (e.g., <i>Q</i>₀, <i>P</i><sub>MAX</sub>), with each approach presenting respective strengths and trade-offs. This work introduces and demonstrates an adaptive task capable of elucidating key features of operant demand without relying on nonlinear regression (i.e., a targeted form of empirical <i>P</i><sub>MAX</sub>). An adaptive algorithm based on reinforcement learning is used to systematically guide questioning in the search for participant-level estimates related to peak work (e.g., <i>P</i><sub>MAX</sub>), and this algorithm was evaluated across four varying iteration lengths (i.e., five, 10, 15, and 20 sequentially updated questions). Equivalence testing with simulated agent responses revealed that tasks with five or more sequentially updated questions recovered <i>P</i><sub>MAX</sub> values statistically equivalent to seeded <i>P</i><sub>MAX</sub> values, which provided evidence suggesting that quantitative modeling (i.e., nonlinear regression) may not be necessary to reveal valuable features of reinforcer consumption and how consumption scales as a function of price. Discussions are presented regarding extensions of contemporary hypothetical purchase tasks and strategies for extracting and comparing critical aspects of consumer demand. (PsycInfo Database Record (c) 2025 APA, all rights reserved).</p>","PeriodicalId":12089,"journal":{"name":"Experimental and clinical psychopharmacology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143491360","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Brett W Gelino, Jill A Rabinowitz, Brion S Maher, Julia W Felton, Richard Yi, Matthew D Novak, Sandra Sanchez-Roige, Abraham A Palmer, Justin C Strickland
{"title":"Delay discounting data in the Adolescent Brain Cognitive Development (ABCD) study: Modeling and analysis considerations.","authors":"Brett W Gelino, Jill A Rabinowitz, Brion S Maher, Julia W Felton, Richard Yi, Matthew D Novak, Sandra Sanchez-Roige, Abraham A Palmer, Justin C Strickland","doi":"10.1037/pha0000766","DOIUrl":"https://doi.org/10.1037/pha0000766","url":null,"abstract":"<p><p>This report provides a primer to delay discounting data in the context of the Adolescent Brain Cognitive Development (ABCD) Study. Delay discounting describes the tendency for organisms to devalue temporally constrained outcomes. This decision-making framework has garnered attention from multiple fields for its association with various behavioral health conditions like substance use disorder. Importantly, the literature on delay discounting describes many approaches to analyzing and interpreting discounting data. To be most beneficial to the broader scientific audience, consistency and reproducibility in how delay discounting data are operationalized, analyzed, and interpreted is key. We describe relevant data analysis methods for use with the ABCD Study, a large-cohort longitudinal study (<i>N</i> = 11,878) examining delay discounting among youth respondents across child and adolescent development. Particular attention is given to data collected from children and younger populations given their relevance to ABCD research and potential merit for unique analytic considerations (e.g., higher rates of atypical responding). We first provide a background on the broad theoretical and conceptual aspects of discounting research. We then review discounting assessment, describing conventional titration tasks and the more novel algorithm-based approaches to generating descriptive metrics. We conclude with recommendations for best practice modeling, data handling and exclusions based on nonsystematic data, and ensuing interpretations. Analytic pipelines and coding are provided for investigator use. (PsycInfo Database Record (c) 2025 APA, all rights reserved).</p>","PeriodicalId":12089,"journal":{"name":"Experimental and clinical psychopharmacology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143491361","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sarah Marler, Michael Rabbia, Kevin Sanders, Michael Derks, Lorna Bailey, Alexandr Vilimovskij, Joerg Maurer, Anna-Lena Nordstroem, Heather Guthrie
{"title":"Efficacy and safety of balovaptan for posttraumatic stress disorder: A randomized, placebo-controlled trial.","authors":"Sarah Marler, Michael Rabbia, Kevin Sanders, Michael Derks, Lorna Bailey, Alexandr Vilimovskij, Joerg Maurer, Anna-Lena Nordstroem, Heather Guthrie","doi":"10.1037/pha0000740","DOIUrl":"10.1037/pha0000740","url":null,"abstract":"<p><p>Posttraumatic stress disorder (PTSD) has a significant impact on quality of life and affects more than 13 million individuals in the United States, with limited treatments available. EXUVIA (NCT05401565) was a Phase 2, randomized, placebo-controlled, double-blind trial, conducted across eight sites in the United States. The study aimed to assess the efficacy, safety, and pharmacokinetics of balovaptan, a highly selective vasopressin 1a receptor antagonist, in adults with PTSD. Between August 2022 and October 2023, a total of 57 adult participants (aged 18-60 years) were screened, and 29 participants were randomly allocated (1:1) to receive either balovaptan (13/29 [44.8%]) or placebo (16/29 [55.2%]). No meaningful differences were observed for balovaptan (-17.2 [± 10.7]) versus placebo (-15.6 [± 10.7]) as measured by the primary endpoint of change from baseline at Week 12 in Clinician-Administered PTSD Scale for <i>Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition</i> total symptom severity score. No meaningful differences for balovaptan versus placebo were observed at Week 12 for any secondary endpoints. Balovaptan was well tolerated with no new safety findings. The number of participants with at least one adverse event of any intensity was 9/13 (69.2%) in the balovaptan group and 7/16 (43.8%) in the placebo group. (PsycInfo Database Record (c) 2025 APA, all rights reserved).</p>","PeriodicalId":12089,"journal":{"name":"Experimental and clinical psychopharmacology","volume":" ","pages":"43-52"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616810","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}