Neuroinflammation has been implicated in the pathophysiology of bipolar disorder. Some evidence s... more Neuroinflammation has been implicated in the pathophysiology of bipolar disorder. Some evidence shows that nonsteroidal anti-inflammatory drugs (NSAIDs) have promising antidepressant effects. The antioxidant N-acetylcysteine (NAC) may enhance the effects of NSAIDs. No study has, however, tested the adjunctive therapeutic benefits of an NSAID and NAC in bipolar disorder. The sample included 24 medicated patients diagnosed with DSM-IV-TR bipolar disorder who were aged 18-65 years and had a Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 20. Participants were randomly assigned to receive either aspirin (1,000 mg), NAC (1,000 mg), combined aspirin and NAC (1,000 mg each), or placebo. Data were collected between 2013 and 2017. The primary outcome was a ≥ 50% reduction in MADRS scores. Participants completed mood and global functioning questionnaires. They also underwent blood tests prior to and following 8 and 16 weeks of treatment. A Bayesian analytic method was adopted, and posterior probability distributions were calculated to determine the probability of treatment response. Following the first 8-week treatment phase, individuals on treatment with placebo and NAC + aspirin had a similar probability for successful treatment response (about 70%). Following a 16-week treatment period, NAC + aspirin was associated with higher probability of treatment response (67%) compared to placebo (55%), NAC (57%), and aspirin (33%). There was no treatment effect on interleukin-6 and C-reactive protein levels at either 8 or 16 weeks. The coadministration of NAC and aspirin during a period of 16 weeks was associated with a reduction in depressive symptoms. The adverse effects were minimal. These preliminary findings may serve as a starting point for future studies assessing the efficacy, tolerability, and safety of anti-inflammatory and antioxidant agents in the treatment of bipolar depression. ClinicalTrials.gov identifier: NCT01797575.
Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors, May 1, 2018
Cue reactivity has great potential to advance our understanding of posttraumatic stress disorder ... more Cue reactivity has great potential to advance our understanding of posttraumatic stress disorder (PTSD), substance use disorder (SUD), and PTSD/SUD comorbidity. The present investigation examined distress tolerance (DT) with regard to trauma and substance cue reactivity. Participants included 58 low-income, inner-city adults (49.1% women; M = 45.73, SD = 10.00) with substance dependence and at least 4 symptoms of PTSD. A script-driven cue reactivity paradigm was utilized. Four DT measures were administered, including the Distress Tolerance Scale (DTS), Mirror-Tracing Persistence Task (MTPT), Breath-Holding Task (BH), and Paced Auditory Serial Addition Task (PASAT). Lower DT, as indexed by MTPT duration, was significantly predictive of greater levels of self-reported substance cravings/urges in response to trauma cues, above and beyond covariates. Lower DTS scores predicted lower levels of self-reported control/safety ratings in response to substance cues. None of the DT indices was ...
Recent advances in data science were used capitalize on the extensive quantity of data available ... more Recent advances in data science were used capitalize on the extensive quantity of data available in electronic health records to predict patient aggressive events. This retrospective study utilized electronic health records (N = 29,841) collected between January 2010 and December 2015 at Harris County Psychiatric Center, a 274-bed safety net community psychiatric facility. The primary outcome of interest was the presence (1.4%) versus absence (98.6%) of an aggressive event toward staff or patients. The best-performing algorithm, penalized generalized linear modeling, achieved an area under the curve = 0.7801. The strongest predictors of patient aggressive events included homelessness (b = 0.52), having been convicted of assault (b = 0.31), and having witnessed abuse (b = -0.28). The algorithm was also used to generate a cost-optimized probability threshold (6%) for an aggressive event, theoretically affording individualized hospital-staff coverage on the 2.8% of inpatients at highes...
Previous studies have indicated that transcranial direct current stimulation (tDCS) with the anod... more Previous studies have indicated that transcranial direct current stimulation (tDCS) with the anode over the motor cortex and the cathode over the contralateral supraorbital region is effective in reducing clinical pain in patients with chronic pain, but these studies have not focused on experimental pain sensitivity. Therefore, the aim of this study was to examine the effect of tDCS on experimental pain sensitivity in older adults with knee osteoarthritis (OA). Forty community-dwelling participants aged 50-70 years with knee OA pain were randomly assigned to receive five daily sessions of 2 mA tDCS for 20 minutes (n = 20) or sham tDCS (n = 20) using a parallel group design. A multimodal quantitative sensory testing battery was completed, including heat pain, pressure pain threshold (PPT), punctate mechanical pain, and conditioned pain modulation (CPM). The active tDCS group showed greater increases in heat pain thresholds and tolerances, PPTs, and CPM, and reductions in punctate pai...
Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, Jan 14, 2018
As the tobacco industry and market evolves, there is a growing need to understand the patterns of... more As the tobacco industry and market evolves, there is a growing need to understand the patterns of use of tobacco products and how they relate to demographics, dependency, withdrawal, and quit behavior. We analyzed data from wave 1 of the PATH Study consisting of 14856 individuals. Current users were defined as consuming at least 1 of 10 tobacco products. We performed a latent class analysis (LCA) to identify patterns of tobacco use. We used multinomial regression analysis to explore the association between these patterns with covariates representing socioeconomic status dependence/addiction, past quit attempts, and withdrawal severity. We identified four groups of current tobacco users with distinct profiles: (1) 61% of the sample were identified as cigarette-only users; (2) 9% were smokeless tobacco users; (3) 17% of the sample were characterized by being current users of all types of combustible tobacco including cigars, cigarillos, filtered cigars, and smoking a pipe (4) finally,...
Pain management after injury is critically important for functional recovery. Although opioids ha... more Pain management after injury is critically important for functional recovery. Although opioids have been a mainstay for treatment of pain, they are associated with adverse events and may contribute to long-term use or abuse. Opioid-minimizing multimodal pain regimens have the potential to reduce exposure to opioids without compromising pain control. This article details an ongoing clinical trial comparing two pill-based, opioid-minimizing, multimodal pain strategies. This is a single-center, parallel-group, randomized, controlled comparative effectiveness trial comparing two multimodal pain regimens in adult trauma patients. All patients 16 years and older admitted to the Red Duke Trauma Institute are eligible unless they are pregnant, a prisoner, under observation status, or a non-acute trauma patient. At admission to the trauma service, patients are enrolled and randomized to one of two multimodal pain regimens. The primary outcome is opioid use, measured by morphine milligram equ...
Despite strong recommendations, only 40.6% of pregnant women attending two prenatal clinics were... more Despite strong recommendations, only 40.6% of pregnant women attending two prenatal clinics were vaccinated against influenza during the 2009 pandemic. We tested whether an opting-out approach would improve vaccine uptake. We conducted a randomized quality improvement (QI) trial to compare opting-out with conventional opting-in consent for influenza immunization. Women age ≥ 18 years attending the University of Texas Health Science Center at Houston (UTHealth) or UT-Medical Branch (UTMB) prenatal clinics during the 2010-2011 influenza season, were eligible. We enrolled 280 women (140 UTHealth, 140 UTMB). Both groups had similar mean age (26.0 ± 5.5 years), mean gestational age (19.4 ± 9.5 weeks), and percent with underlying health conditions (20.7%). Vaccination rates with opting-in and opting-out were similar among all (83 vs. 84%), UTHealth (87 vs. 93%), and UTMB patients (79 vs.76%) ( > 0.05). In subsamples of patients assessed, consent strategy did not significantly affec...
Machine-learning can elucidate complex relationships/provide insight to important variables for l... more Machine-learning can elucidate complex relationships/provide insight to important variables for large datasets. This study aimed to develop an accurate model to predict neonatal surgical site infections (SSI) using different statistical methods. The 2012-2015 National Surgical Quality Improvement Program-Pediatric for neonates was utilized for development and validations models. The primary outcome was any SSI. Models included different algorithms: full multiple logistic regression (LR), a priori clinical LR, random forest classification (RFC), and a hybrid model (combination of clinical knowledge and significant variables from RF) to maximize predictive power. 16,842 patients (median age 18 days, IQR 3-58) were included. 542 SSIs (4%) were identified. Agreement was observed for multiple covariates among significant variables between models. Area under the curve for each model was similar (full model 0.65, clinical model 0.67, RF 0.68, hybrid LR 0.67); however, the hybrid model util...
Despite the availability of several efficacious smoking cessation treatments, fewer than 25% of s... more Despite the availability of several efficacious smoking cessation treatments, fewer than 25% of smokers who quit remain abstinent 1 year post-treatment. This study aimed to determine if varenicline and bupropion combination treatment would result in higher abstinence rates than varenicline alone. A double-blind, randomized, parallel-group smoking cessation clinical trial in which participants were exposed to 12 weeks of treatment and followed for 12 months. Hospital-based out-patient clinic in Texas, USA specializing in cancer prevention. A total of 385 community smokers (58.44% male) who smoked 1 pack of cigarettes/day [mean = 19.66 cigarettes/day, standard deviation (SD) = 9.45]; had average carbon monoxide (CO) of 26.43 parts per million (SD = 13.74); and were moderately dependent (Fagerström Test for Cigarette Dependence = 4.79; SD = 2.07). Smokers were randomized in a 3 : 1 (active: Placebo) ratio to 12 weeks of treatment as follows: placebo (n = 56), varenicline (Var; n = 166)...
Posttraumatic stress disorder (PTSD) and substance use disorders (SUD) are complex psychiatric co... more Posttraumatic stress disorder (PTSD) and substance use disorders (SUD) are complex psychiatric conditions that commonly co-occur. No evidence-based, 'gold standard' treatments for PTSD/SUD comorbidity are currently available. The present pilot randomized clinical trial was designed to evaluate the feasibility and preliminary efficacy of a novel, integrated cognitive-behavioral treatment approach for PTSD/SUD, entitled Treatment of Integrated Posttraumatic Stress and Substance Use (TIPSS), as compared to standard cognitive-behavioral treatment (CBT) for SUD. The TIPSS program integrates cognitive processing therapy with CBT for SUD for the treatment of co-occurring PTSD/SUD. Both treatment conditions are comprised of 12, 60-minute individual psychotherapy sessions, delivered twice-weekly over six weeks. Primary aims examine whether TIPSS, compared to standard CBT for SUD, reduces: (1) PTSD symptoms and (2) substance use outcomes (i.e., self-report, objective). Secondary aims ...
Cigarette smoking is the greatest preventable cause of morbidity and premature mortality in the U... more Cigarette smoking is the greatest preventable cause of morbidity and premature mortality in the United States. Approved pharmacological treatments for smoking cessation are marginally effective, underscoring the need for improved pharmacotherapies. A novel approach might use glucagon-like peptide-1 (GLP-1) agonists, which reduce alcohol and drug use in preclinical studies. GLP-1 is produced in the intestinal L-cells and in the hindbrain. The peptide maintains glucose homeostasis and reduces food intake. Several GLP-1 agonists are used clinically to treat type 2 diabetes and obesity, but none have been tested in humans to reduce smoking. We will examine whether extended-release exenatide reduces smoking, craving, and withdrawal symptoms, as well as cue-induced craving for cigarettes. We will enroll prediabetic and/or overweight treatment seeking smokers (n = 90) into a double-blind, placebo-controlled, randomized clinical trial. Participants will be randomized in a 1:1 ratio to recei...
Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, Jan 6, 2017
Varenicline and bupropion are two effective smoking cessation pharmacotherapies. Researchers have... more Varenicline and bupropion are two effective smoking cessation pharmacotherapies. Researchers have hypothesized that they might be effective, in part, because they reduce cue reactivity and cue-induced cravings. Here, we used event-related potentials (ERPs) to directly measure brain responses to cigarette-related and other motivationally relevant images during a pharmacologically aided quit attempt. Smokers involved in a 12-week placebo-controlled double-blind clinical trial of smoking cessation medications (varenicline, bupropion, placebo) took part in the study. We assessed participants at two time points: 24 hours (n = 140) and four weeks (n = 176) after the quit date. At both sessions, we measured the amplitude of the Late Positive Potential (LPP), an ERP component reliably associated with motivational relevance, and self-reported tonic craving using the brief version of the Questionnaire of Smoking Urges (QSU-Brief). At both sessions, emotional and cigarette-related images evoke...
Pioglitazone (PIO), a potent agonist of PPAR-gamma, is a promising candidate treatment for cocain... more Pioglitazone (PIO), a potent agonist of PPAR-gamma, is a promising candidate treatment for cocaine use disorder (CUD). We tested the effects of PIO on targeted mechanisms relevant to CUD: cocaine craving and brain white matter (WM) integrity. Feasibility, medication compliance, and tolerability were evaluated. Two-arm double-blind randomized controlled proof-of-concept pilot trial of PIO or placebo (PLC). Single-site outpatient treatment research clinic in Houston, Texas, USA. Thirty treatment-seeking adults with CUD. Mean [standard deviation (SD)] age was 47.8 (7.45), education was 12.7 (1.5), with 19.3 (7.8) years of reported cocaine use. Eighteen of the 30 participants (8 = PIO; 10 = PLC) completed diffusion tensor imaging (DTI) of WM integrity at pre/post-treatment. Study medication was dispensed at thrice weekly visits along with once weekly cognitive behavioral therapy for 12 weeks. Measures of target engagement mechanisms of interest included cocaine craving assessed by the B...
Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, Jun 1, 2017
The cue reactivity paradigm (ie, comparing responses evoked by drug-related cues to those evoked ... more The cue reactivity paradigm (ie, comparing responses evoked by drug-related cues to those evoked by neutral cues) cannot provide conclusive information about the motivational relevance of drug-related cues. Responses to non-drug-related motivationally relevant stimuli should be used to appropriately gauge the level of motivational relevance that substance-dependent individuals attribute to drug-related cues.
American journal of preventive medicine, Jan 17, 2017
Alcohol and tobacco use are common among U.S. women, yet if used during pregnancy these substance... more Alcohol and tobacco use are common among U.S. women, yet if used during pregnancy these substances present significant preventable risks to prenatal and perinatal health. Because use of alcohol and tobacco often continue into the first trimester and beyond, especially among women with unintended pregnancies, effective evidence-based approaches are needed to decrease these risk behaviors. This study was designed to test the efficacy of CHOICES Plus, a preconception intervention for reducing the risk of alcohol- and tobacco-exposed pregnancies (AEPs and TEPs). RCT with two intervention groups: CHOICES Plus (n=131) versus Brief Advice (n=130). Data collected April 2011 to October 2013. Data analysis finalized February 2016. Settings were 12 primary care clinics in a large Texas public healthcare system. Participants were women who were non-sterile, non-pregnant, aged 18-44 years, drinking more than three drinks per day or more than seven drinks per week, sexually active, and not using ...
We have shown that differences in the level of neural activation to stimuli associated with smoki... more We have shown that differences in the level of neural activation to stimuli associated with smoking vs. natural rewards, a biomarker related to reward sensitivity, predict treatment outcome. This paper examined whether this biomarker moderates the impact of bupropion or varenicline on smoking cessation. Prior to treatment randomization, smokers (N = 180) in a placebo-controlled trial using bupropion and varenicline completed event-related potential recording (late positive potential, LPP) while viewing pleasant (P), cigarette (C)-related, and other pictures. We used Bayesian models to estimate the probability of interaction between treatment and the LPP for both efficacy and comparative effectiveness analyses. Efficacy analysis showed that smokers with more neural activation to pleasant vs. cigarette-related stimuli (P > C) had a 98-99% chance of achieving greater abstinence than placebo (OR >1.00), using either medication from the end of treatment (EOT, primary outcome) throu...
Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, Jan 22, 2017
Research suggests a strong association between negative affect and smoking. However, little is kn... more Research suggests a strong association between negative affect and smoking. However, little is known about the association between negative affect and smoking among individuals who switch to reduced-nicotine cigarettes. The goal of this study was to examine the extent to which cigarette nicotine content moderates the relationship between negative affect and smoking over time. 717 participants, 237 in the normal nicotine content (NNC; 15.8 mg/g and usual brand) cigarette group and 480 in the very low nicotine content (VLNC; 2.4 mg/g nicotine or less) cigarette group, participated in a randomized trial that examined the effects of cigarette nicotine content on smoking behavior over six weeks. We used parallel process latent growth curve modeling to estimate the relationship between changes in negative affect (NA) and changes in the numbers of cigarettes smoked per day (CPD), from baseline to 6 weeks, as a function of cigarette nicotine content. The relationship between NA and investig...
Neuroinflammation has been implicated in the pathophysiology of bipolar disorder. Some evidence s... more Neuroinflammation has been implicated in the pathophysiology of bipolar disorder. Some evidence shows that nonsteroidal anti-inflammatory drugs (NSAIDs) have promising antidepressant effects. The antioxidant N-acetylcysteine (NAC) may enhance the effects of NSAIDs. No study has, however, tested the adjunctive therapeutic benefits of an NSAID and NAC in bipolar disorder. The sample included 24 medicated patients diagnosed with DSM-IV-TR bipolar disorder who were aged 18-65 years and had a Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 20. Participants were randomly assigned to receive either aspirin (1,000 mg), NAC (1,000 mg), combined aspirin and NAC (1,000 mg each), or placebo. Data were collected between 2013 and 2017. The primary outcome was a ≥ 50% reduction in MADRS scores. Participants completed mood and global functioning questionnaires. They also underwent blood tests prior to and following 8 and 16 weeks of treatment. A Bayesian analytic method was adopted, and posterior probability distributions were calculated to determine the probability of treatment response. Following the first 8-week treatment phase, individuals on treatment with placebo and NAC + aspirin had a similar probability for successful treatment response (about 70%). Following a 16-week treatment period, NAC + aspirin was associated with higher probability of treatment response (67%) compared to placebo (55%), NAC (57%), and aspirin (33%). There was no treatment effect on interleukin-6 and C-reactive protein levels at either 8 or 16 weeks. The coadministration of NAC and aspirin during a period of 16 weeks was associated with a reduction in depressive symptoms. The adverse effects were minimal. These preliminary findings may serve as a starting point for future studies assessing the efficacy, tolerability, and safety of anti-inflammatory and antioxidant agents in the treatment of bipolar depression. ClinicalTrials.gov identifier: NCT01797575.
Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors, May 1, 2018
Cue reactivity has great potential to advance our understanding of posttraumatic stress disorder ... more Cue reactivity has great potential to advance our understanding of posttraumatic stress disorder (PTSD), substance use disorder (SUD), and PTSD/SUD comorbidity. The present investigation examined distress tolerance (DT) with regard to trauma and substance cue reactivity. Participants included 58 low-income, inner-city adults (49.1% women; M = 45.73, SD = 10.00) with substance dependence and at least 4 symptoms of PTSD. A script-driven cue reactivity paradigm was utilized. Four DT measures were administered, including the Distress Tolerance Scale (DTS), Mirror-Tracing Persistence Task (MTPT), Breath-Holding Task (BH), and Paced Auditory Serial Addition Task (PASAT). Lower DT, as indexed by MTPT duration, was significantly predictive of greater levels of self-reported substance cravings/urges in response to trauma cues, above and beyond covariates. Lower DTS scores predicted lower levels of self-reported control/safety ratings in response to substance cues. None of the DT indices was ...
Recent advances in data science were used capitalize on the extensive quantity of data available ... more Recent advances in data science were used capitalize on the extensive quantity of data available in electronic health records to predict patient aggressive events. This retrospective study utilized electronic health records (N = 29,841) collected between January 2010 and December 2015 at Harris County Psychiatric Center, a 274-bed safety net community psychiatric facility. The primary outcome of interest was the presence (1.4%) versus absence (98.6%) of an aggressive event toward staff or patients. The best-performing algorithm, penalized generalized linear modeling, achieved an area under the curve = 0.7801. The strongest predictors of patient aggressive events included homelessness (b = 0.52), having been convicted of assault (b = 0.31), and having witnessed abuse (b = -0.28). The algorithm was also used to generate a cost-optimized probability threshold (6%) for an aggressive event, theoretically affording individualized hospital-staff coverage on the 2.8% of inpatients at highes...
Previous studies have indicated that transcranial direct current stimulation (tDCS) with the anod... more Previous studies have indicated that transcranial direct current stimulation (tDCS) with the anode over the motor cortex and the cathode over the contralateral supraorbital region is effective in reducing clinical pain in patients with chronic pain, but these studies have not focused on experimental pain sensitivity. Therefore, the aim of this study was to examine the effect of tDCS on experimental pain sensitivity in older adults with knee osteoarthritis (OA). Forty community-dwelling participants aged 50-70 years with knee OA pain were randomly assigned to receive five daily sessions of 2 mA tDCS for 20 minutes (n = 20) or sham tDCS (n = 20) using a parallel group design. A multimodal quantitative sensory testing battery was completed, including heat pain, pressure pain threshold (PPT), punctate mechanical pain, and conditioned pain modulation (CPM). The active tDCS group showed greater increases in heat pain thresholds and tolerances, PPTs, and CPM, and reductions in punctate pai...
Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, Jan 14, 2018
As the tobacco industry and market evolves, there is a growing need to understand the patterns of... more As the tobacco industry and market evolves, there is a growing need to understand the patterns of use of tobacco products and how they relate to demographics, dependency, withdrawal, and quit behavior. We analyzed data from wave 1 of the PATH Study consisting of 14856 individuals. Current users were defined as consuming at least 1 of 10 tobacco products. We performed a latent class analysis (LCA) to identify patterns of tobacco use. We used multinomial regression analysis to explore the association between these patterns with covariates representing socioeconomic status dependence/addiction, past quit attempts, and withdrawal severity. We identified four groups of current tobacco users with distinct profiles: (1) 61% of the sample were identified as cigarette-only users; (2) 9% were smokeless tobacco users; (3) 17% of the sample were characterized by being current users of all types of combustible tobacco including cigars, cigarillos, filtered cigars, and smoking a pipe (4) finally,...
Pain management after injury is critically important for functional recovery. Although opioids ha... more Pain management after injury is critically important for functional recovery. Although opioids have been a mainstay for treatment of pain, they are associated with adverse events and may contribute to long-term use or abuse. Opioid-minimizing multimodal pain regimens have the potential to reduce exposure to opioids without compromising pain control. This article details an ongoing clinical trial comparing two pill-based, opioid-minimizing, multimodal pain strategies. This is a single-center, parallel-group, randomized, controlled comparative effectiveness trial comparing two multimodal pain regimens in adult trauma patients. All patients 16 years and older admitted to the Red Duke Trauma Institute are eligible unless they are pregnant, a prisoner, under observation status, or a non-acute trauma patient. At admission to the trauma service, patients are enrolled and randomized to one of two multimodal pain regimens. The primary outcome is opioid use, measured by morphine milligram equ...
Despite strong recommendations, only 40.6% of pregnant women attending two prenatal clinics were... more Despite strong recommendations, only 40.6% of pregnant women attending two prenatal clinics were vaccinated against influenza during the 2009 pandemic. We tested whether an opting-out approach would improve vaccine uptake. We conducted a randomized quality improvement (QI) trial to compare opting-out with conventional opting-in consent for influenza immunization. Women age ≥ 18 years attending the University of Texas Health Science Center at Houston (UTHealth) or UT-Medical Branch (UTMB) prenatal clinics during the 2010-2011 influenza season, were eligible. We enrolled 280 women (140 UTHealth, 140 UTMB). Both groups had similar mean age (26.0 ± 5.5 years), mean gestational age (19.4 ± 9.5 weeks), and percent with underlying health conditions (20.7%). Vaccination rates with opting-in and opting-out were similar among all (83 vs. 84%), UTHealth (87 vs. 93%), and UTMB patients (79 vs.76%) ( > 0.05). In subsamples of patients assessed, consent strategy did not significantly affec...
Machine-learning can elucidate complex relationships/provide insight to important variables for l... more Machine-learning can elucidate complex relationships/provide insight to important variables for large datasets. This study aimed to develop an accurate model to predict neonatal surgical site infections (SSI) using different statistical methods. The 2012-2015 National Surgical Quality Improvement Program-Pediatric for neonates was utilized for development and validations models. The primary outcome was any SSI. Models included different algorithms: full multiple logistic regression (LR), a priori clinical LR, random forest classification (RFC), and a hybrid model (combination of clinical knowledge and significant variables from RF) to maximize predictive power. 16,842 patients (median age 18 days, IQR 3-58) were included. 542 SSIs (4%) were identified. Agreement was observed for multiple covariates among significant variables between models. Area under the curve for each model was similar (full model 0.65, clinical model 0.67, RF 0.68, hybrid LR 0.67); however, the hybrid model util...
Despite the availability of several efficacious smoking cessation treatments, fewer than 25% of s... more Despite the availability of several efficacious smoking cessation treatments, fewer than 25% of smokers who quit remain abstinent 1 year post-treatment. This study aimed to determine if varenicline and bupropion combination treatment would result in higher abstinence rates than varenicline alone. A double-blind, randomized, parallel-group smoking cessation clinical trial in which participants were exposed to 12 weeks of treatment and followed for 12 months. Hospital-based out-patient clinic in Texas, USA specializing in cancer prevention. A total of 385 community smokers (58.44% male) who smoked 1 pack of cigarettes/day [mean = 19.66 cigarettes/day, standard deviation (SD) = 9.45]; had average carbon monoxide (CO) of 26.43 parts per million (SD = 13.74); and were moderately dependent (Fagerström Test for Cigarette Dependence = 4.79; SD = 2.07). Smokers were randomized in a 3 : 1 (active: Placebo) ratio to 12 weeks of treatment as follows: placebo (n = 56), varenicline (Var; n = 166)...
Posttraumatic stress disorder (PTSD) and substance use disorders (SUD) are complex psychiatric co... more Posttraumatic stress disorder (PTSD) and substance use disorders (SUD) are complex psychiatric conditions that commonly co-occur. No evidence-based, 'gold standard' treatments for PTSD/SUD comorbidity are currently available. The present pilot randomized clinical trial was designed to evaluate the feasibility and preliminary efficacy of a novel, integrated cognitive-behavioral treatment approach for PTSD/SUD, entitled Treatment of Integrated Posttraumatic Stress and Substance Use (TIPSS), as compared to standard cognitive-behavioral treatment (CBT) for SUD. The TIPSS program integrates cognitive processing therapy with CBT for SUD for the treatment of co-occurring PTSD/SUD. Both treatment conditions are comprised of 12, 60-minute individual psychotherapy sessions, delivered twice-weekly over six weeks. Primary aims examine whether TIPSS, compared to standard CBT for SUD, reduces: (1) PTSD symptoms and (2) substance use outcomes (i.e., self-report, objective). Secondary aims ...
Cigarette smoking is the greatest preventable cause of morbidity and premature mortality in the U... more Cigarette smoking is the greatest preventable cause of morbidity and premature mortality in the United States. Approved pharmacological treatments for smoking cessation are marginally effective, underscoring the need for improved pharmacotherapies. A novel approach might use glucagon-like peptide-1 (GLP-1) agonists, which reduce alcohol and drug use in preclinical studies. GLP-1 is produced in the intestinal L-cells and in the hindbrain. The peptide maintains glucose homeostasis and reduces food intake. Several GLP-1 agonists are used clinically to treat type 2 diabetes and obesity, but none have been tested in humans to reduce smoking. We will examine whether extended-release exenatide reduces smoking, craving, and withdrawal symptoms, as well as cue-induced craving for cigarettes. We will enroll prediabetic and/or overweight treatment seeking smokers (n = 90) into a double-blind, placebo-controlled, randomized clinical trial. Participants will be randomized in a 1:1 ratio to recei...
Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, Jan 6, 2017
Varenicline and bupropion are two effective smoking cessation pharmacotherapies. Researchers have... more Varenicline and bupropion are two effective smoking cessation pharmacotherapies. Researchers have hypothesized that they might be effective, in part, because they reduce cue reactivity and cue-induced cravings. Here, we used event-related potentials (ERPs) to directly measure brain responses to cigarette-related and other motivationally relevant images during a pharmacologically aided quit attempt. Smokers involved in a 12-week placebo-controlled double-blind clinical trial of smoking cessation medications (varenicline, bupropion, placebo) took part in the study. We assessed participants at two time points: 24 hours (n = 140) and four weeks (n = 176) after the quit date. At both sessions, we measured the amplitude of the Late Positive Potential (LPP), an ERP component reliably associated with motivational relevance, and self-reported tonic craving using the brief version of the Questionnaire of Smoking Urges (QSU-Brief). At both sessions, emotional and cigarette-related images evoke...
Pioglitazone (PIO), a potent agonist of PPAR-gamma, is a promising candidate treatment for cocain... more Pioglitazone (PIO), a potent agonist of PPAR-gamma, is a promising candidate treatment for cocaine use disorder (CUD). We tested the effects of PIO on targeted mechanisms relevant to CUD: cocaine craving and brain white matter (WM) integrity. Feasibility, medication compliance, and tolerability were evaluated. Two-arm double-blind randomized controlled proof-of-concept pilot trial of PIO or placebo (PLC). Single-site outpatient treatment research clinic in Houston, Texas, USA. Thirty treatment-seeking adults with CUD. Mean [standard deviation (SD)] age was 47.8 (7.45), education was 12.7 (1.5), with 19.3 (7.8) years of reported cocaine use. Eighteen of the 30 participants (8 = PIO; 10 = PLC) completed diffusion tensor imaging (DTI) of WM integrity at pre/post-treatment. Study medication was dispensed at thrice weekly visits along with once weekly cognitive behavioral therapy for 12 weeks. Measures of target engagement mechanisms of interest included cocaine craving assessed by the B...
Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, Jun 1, 2017
The cue reactivity paradigm (ie, comparing responses evoked by drug-related cues to those evoked ... more The cue reactivity paradigm (ie, comparing responses evoked by drug-related cues to those evoked by neutral cues) cannot provide conclusive information about the motivational relevance of drug-related cues. Responses to non-drug-related motivationally relevant stimuli should be used to appropriately gauge the level of motivational relevance that substance-dependent individuals attribute to drug-related cues.
American journal of preventive medicine, Jan 17, 2017
Alcohol and tobacco use are common among U.S. women, yet if used during pregnancy these substance... more Alcohol and tobacco use are common among U.S. women, yet if used during pregnancy these substances present significant preventable risks to prenatal and perinatal health. Because use of alcohol and tobacco often continue into the first trimester and beyond, especially among women with unintended pregnancies, effective evidence-based approaches are needed to decrease these risk behaviors. This study was designed to test the efficacy of CHOICES Plus, a preconception intervention for reducing the risk of alcohol- and tobacco-exposed pregnancies (AEPs and TEPs). RCT with two intervention groups: CHOICES Plus (n=131) versus Brief Advice (n=130). Data collected April 2011 to October 2013. Data analysis finalized February 2016. Settings were 12 primary care clinics in a large Texas public healthcare system. Participants were women who were non-sterile, non-pregnant, aged 18-44 years, drinking more than three drinks per day or more than seven drinks per week, sexually active, and not using ...
We have shown that differences in the level of neural activation to stimuli associated with smoki... more We have shown that differences in the level of neural activation to stimuli associated with smoking vs. natural rewards, a biomarker related to reward sensitivity, predict treatment outcome. This paper examined whether this biomarker moderates the impact of bupropion or varenicline on smoking cessation. Prior to treatment randomization, smokers (N = 180) in a placebo-controlled trial using bupropion and varenicline completed event-related potential recording (late positive potential, LPP) while viewing pleasant (P), cigarette (C)-related, and other pictures. We used Bayesian models to estimate the probability of interaction between treatment and the LPP for both efficacy and comparative effectiveness analyses. Efficacy analysis showed that smokers with more neural activation to pleasant vs. cigarette-related stimuli (P > C) had a 98-99% chance of achieving greater abstinence than placebo (OR >1.00), using either medication from the end of treatment (EOT, primary outcome) throu...
Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, Jan 22, 2017
Research suggests a strong association between negative affect and smoking. However, little is kn... more Research suggests a strong association between negative affect and smoking. However, little is known about the association between negative affect and smoking among individuals who switch to reduced-nicotine cigarettes. The goal of this study was to examine the extent to which cigarette nicotine content moderates the relationship between negative affect and smoking over time. 717 participants, 237 in the normal nicotine content (NNC; 15.8 mg/g and usual brand) cigarette group and 480 in the very low nicotine content (VLNC; 2.4 mg/g nicotine or less) cigarette group, participated in a randomized trial that examined the effects of cigarette nicotine content on smoking behavior over six weeks. We used parallel process latent growth curve modeling to estimate the relationship between changes in negative affect (NA) and changes in the numbers of cigarettes smoked per day (CPD), from baseline to 6 weeks, as a function of cigarette nicotine content. The relationship between NA and investig...
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