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1.
Neurotoxicol Teratol ; : 107371, 2024 Jul 04.
Article in English | MEDLINE | ID: mdl-38971339

ABSTRACT

We examined associations between prenatal tobacco exposure (with and without cannabis exposure) and children's performance on laboratory measures of sustained attention, attentional set shifting, and working memory in middle childhood (9-12 years of child age). Participants were recruited in the first trimester of pregnancy and oversampled for prenatal tobacco exposure; with a smaller sample (n = 133; n = 34 non-substance exposed, n = 37 exposed to tobacco only, n = 62 co-exposed) invited (oversampled for co-exposure) to participate in the middle-childhood assessment (M age = 10.6, SD = 0.77; 68% Black, 20% Hispanic). Results for sustained attention indicated lower attention (percent hits) at the first epoch for tobacco only exposed compared to non-exposed and co-exposed; a trend (p = .07) towards increases in impulsive responding across time (a total of 8 epochs) for tobacco exposed (with and without cannabis) compared to non-exposed children; and a significant association between higher number of cigarettes in the first trimester and greater increases in impulsive responding across epochs. However, children prenatally exposed to tobacco (with and without cannabis) demonstrated greater short-term memory compared to children not prenatally exposed, and this difference was driven by higher scores for children prenatally co-exposed to tobacco and cannabis compared to those who were non-exposed. Overall, results suggest that prenatal tobacco exposure, especially in the first trimester, may increase risk for impulsive responding on tasks requiring sustained attention, and that co-use of cannabis did not exacerbate these associations. The higher short-term memory scores among children who were co-exposed compared to non-exposed are perplexing and need replication, particularly in studies with larger sample sizes and samples exposed only to cannabis to examine this more closely.

2.
Clin Pharmacol Ther ; 115(6): 1277-1281, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38369951

ABSTRACT

Varenicline, the most efficacious smoking cessation monotherapy, produces abnormal dreams. Although genetic contributions to varenicline-associated nausea and cessation have been identified, the role of genetics in abnormal dreams is unknown. We conducted a genomewide association study (GWAS) of abnormal dreams in 188 European ancestry smokers treated with varenicline (NCT01314001). Additive genetic models examined the likelihood of experiencing abnormal dreams 2 weeks following varenicline initiation. For the top locus, we tested for selectivity to varenicline, effects on cessation, replication, and generalizability to African ancestry (AA) individuals. The top GWAS variant associated with abnormal dreams was rs901886, mapping to intron 2 of ICAM5 on chromosome 19. The prevalence of abnormal dreams in those with rs901886 CC, CT, and TT genotypes was 15%, 36%, and 62%, respectively (odds ratio = 2.94 for T vs. C, 95% confidence interval = 1.92-4.55, P = 2.03e-7; T allele frequency = 52%). This rs901886 association was selective to varenicline (P values > 0.05 on nicotine patch and placebo). There were also positive associations for rs901886 T (vs. C allele, P = 0.03) and for abnormal dreams (P = 0.06) with varenicline-aided cessation. Neither rs901886 (P = 0.40) nor abnormal dreams (P = 0.24) were associated with adherence. A similar direction of effect of rs901886 on abnormal dreams was observed in a second varenicline trial (NCT01836276). In AA individuals (n = 137), rs901886 was not associated with abnormal dreams (P = 0.41), but there was an association for a variant located ~ 74.4 kb 5' of ICAM5 (P = 2.56e-3). Variation in ICAM5 may influence abnormal dreams and cessation on varenicline. These findings provide additional support for genetically optimized smoking cessation approaches.


Subject(s)
Dreams , Genome-Wide Association Study , Smoking Cessation Agents , Smoking Cessation , Varenicline , Adult , Female , Humans , Male , Middle Aged , Dreams/drug effects , Polymorphism, Single Nucleotide , Smoking Cessation/methods , Smoking Cessation Agents/adverse effects , Smoking Cessation Agents/therapeutic use , Varenicline/adverse effects
3.
J Clin Transl Sci ; 8(1): e6, 2024.
Article in English | MEDLINE | ID: mdl-38384923

ABSTRACT

Introduction: Despite the central importance of cross-disciplinary collaboration in the Clinical and Translational Science Award (CTSA) network and the implementation of various programs designed to enhance collaboration, rigorous evidence for the efficacy of these approaches is lacking. We conducted a novel randomized controlled trial (RCT; ClinicalTrials.gov identifier: NCT05395286) of a promising approach to enhance collaboration readiness and behavior among 95 early career scholars from throughout the CTSA network. Methods: Participants were randomly assigned (within two cohorts) to participate in an Innovation Lab, a week-long immersive collaboration experience, or to a treatment-as-usual control group. Primary outcomes were change in metrics of self-reported collaboration readiness (through 12-month follow-up) and objective collaboration network size from bibliometrics (through 21 months); secondary outcomes included self-reported number of grants submitted and, among Innovation Lab participants only, reactions to the Lab experience (through 12 months). Results: Short-term reactions from Innovation Lab participants were quite positive, and controlled evidence for a beneficial impact of Innovation Labs over the control condition was observed in the self-reported number of grant proposals in the intent-to-treat sample. Primary measures of collaboration readiness were near ceiling in both groups, limiting the ability to detect enhancement. Collaboration network size increased over time to a comparable degree in both groups. Conclusions: The findings highlight the need for systematic intervention development research to identify efficacious strategies that can be implemented throughout the CTSA network to better support the goal of enhanced cross-disciplinary collaboration.

4.
Transl Behav Med ; 14(1): 60-65, 2024 01 11.
Article in English | MEDLINE | ID: mdl-37904628

ABSTRACT

Ecological Momentary Assessment (EMA) methods are increasingly used by translational scientists to study real-world behavior and experience. The ability to draw meaningful conclusions from EMA research depends upon participant compliance with assessment completion. Most EMA studies provide financial compensation for compliance, but little empirical evidence addresses the impact of reinforcement parameters on the level of compliance. The purpose of this study-within-a-trial was to determine the effects of varying the amount and frequency of reinforcement on EMA compliance in a clinical sample of individuals seeking treatment for cigarette smoking. In the parent clinical trial, participants were asked to complete 9 weeks of EMA (1 daily Morning Assessment and 4 daily Random Assessments). Following a 5-week Standard Payment phase for EMA compliance, 61 individuals seeking treatment for cigarette smoking enrolled in the larger clinical trial were randomized to receive Standard ($1 per assessment, paid biweekly), Frequent ($1 per assessment, paid 3 times per week), or Large ($2 per assessment, paid biweekly) payments for EMA compliance during a 4-week Payment Manipulation Phase. Overall, receiving Frequent or Large payments did not improve EMA compliance compared to Standard payments, Ps > .30. Varying frequency and amount of remuneration for EMA compliance did not generally improve compliance in an ongoing clinical trial, raising further questions about the importance of reinforcement parameters in promoting EMA compliance.


Previous studies have addressed the idea that monetary compensation for participation in research is an effective way to encourage individuals to complete the studies. However, there has been limited exploration as whether the amount and frequency of compensation has an influence on participant adherence. We recruited adults who were seeking cigarette smoking treatment and asked them to complete multiple assessments each day on a smartphone app for 9 weeks. Following completion of the assessments, participants were given monetary compensation. A change after 5 weeks led to some persons receiving $1 per assessment paid three times a week (Frequent Payment Group), while others received $2 per assessment paid biweekly (Large Payment Group), and some continued to receive $1 per assessment paid biweekly (Standard Payment Group) for the next 4 weeks. We found that the experimental payment variations did not significantly change compliance with the assessments. These preliminary findings serve as a benchmark for further research.


Subject(s)
Ecological Momentary Assessment , Humans , Longitudinal Studies
5.
Nicotine Tob Res ; 2023 Nov 23.
Article in English | MEDLINE | ID: mdl-37996099

ABSTRACT

INTRODUCTION: People who metabolize nicotine more quickly are generally less successful at quitting smoking. However, the mechanisms that link individual differences in the nicotine metabolite ratio (NMR), a phenotypic biomarker of the rate of nicotine clearance, to smoking outcomes are unclear. We tested the hypotheses that higher NMR is associated with greater smoking reinforcement, general craving, and cue-induced cigarette craving in a treatment-seeking sample. METHODS: Participants were 252 adults who smoke cigarettes enrolled in a randomized controlled smoking cessation trial (NCT03262662) conducted in Buffalo, New York, USA. Participants completed the Choice Behavior Under Cued Conditions (CBUCC) paradigm, a laboratory choice procedure, ~1 week before the first cessation treatment visit, at which time a saliva sample was collected for NMR assessment. On each CBUCC trial, participants reported cigarette craving during cue presentation (cigarette, water) and spent $0.01-0.25 for a chance (5%-95%) to sample the cue (1 puff, sip), providing measures of smoking reinforcement (spending for cigarettes vs. water), general cigarette craving (averaged across cigarette and water cues), and cue-specific craving (cigarette craving during cigarette vs. water cues). RESULTS: As observed in prior work, the NMR was significantly higher among white and female participants. As expected, both spending and cigarette craving were significantly greater on cigarette compared to water trials. However, contrary to our hypotheses, higher NMR was not associated with greater smoking reinforcement, general craving, or cue-specific craving. CONCLUSIONS: The present data do not support that smoking reinforcement or craving are related to nicotine metabolism among individuals seeking to quit smoking. IMPLICATIONS: Though greater smoking reinforcement, general craving, and cue-specific craving are hypothesized to be linked to faster nicotine metabolism, there was no evidence of such relationships in the present sample of adults seeking to quit smoking. Further research, including replication and consideration of alternate hypotheses, is warranted to elucidate the mechanisms by which the NMR is related to smoking cessation.

7.
J Med Internet Res ; 25: e43826, 2023 06 22.
Article in English | MEDLINE | ID: mdl-37347538

ABSTRACT

BACKGROUND: Ecological momentary assessment (EMA) is increasingly used to evaluate behavioral health processes over extended time periods. The validity of EMA for providing representative, real-world data with high temporal precision is threatened to the extent that EMA compliance drops over time. OBJECTIVE: This research builds on prior short-term studies by evaluating the time course of EMA compliance over 9 weeks and examines predictors of weekly compliance rates among cigarette-using adults. METHODS: A total of 257 daily cigarette-using adults participating in a randomized controlled trial for smoking cessation completed daily smartphone EMA assessments, including 1 scheduled morning assessment and 4 random assessments per day. Weekly EMA compliance was calculated and multilevel modeling assessed the rate of change in compliance over the 9-week assessment period. Participant and study characteristics were examined as predictors of overall compliance and changes in compliance rates over time. RESULTS: Compliance was higher for scheduled morning assessments (86%) than for random assessments (58%) at the beginning of the EMA period (P<.001). EMA compliance declined linearly across weeks, and the rate of decline was greater for morning assessments (2% per week) than for random assessments (1% per week; P<.001). Declines in compliance were stronger for younger participants (P<.001), participants who were employed full-time (P=.03), and participants who subsequently dropped out of the study (P<.001). Overall compliance was higher among White participants compared to Black or African American participants (P=.001). CONCLUSIONS: This study suggests that EMA compliance declines linearly but modestly across lengthy EMA protocols. In general, these data support the validity of EMA for tracking health behavior and hypothesized treatment mechanisms over the course of several months. Future work should target improving compliance among subgroups of participants and investigate the extent to which rapid declines in EMA compliance might prove useful for triggering interventions to prevent study dropout. TRIAL REGISTRATION: ClinicalTrials.gov NCT03262662; https://clinicaltrials.gov/ct2/show/NCT03262662.


Subject(s)
Ecological Momentary Assessment , Health Behavior , Smoking Cessation , Adult , Humans , Black or African American/statistics & numerical data , Health Behavior/ethnology , Smoking Cessation/methods , Smartphone , White/statistics & numerical data , United States/epidemiology
8.
JAMA ; 329(23): 2013-2014, 2023 06 20.
Article in English | MEDLINE | ID: mdl-37261810

ABSTRACT

This Viewpoint discusses the proliferation of decentralized clinical trials during the COVID-19 pandemic and the need for rigorous studies to inform whether decentralized approaches promote or prevent access to clinical trials for people facing health disparities.


Subject(s)
Clinical Trials as Topic , Health Equity , Humans , Healthcare Disparities , Pandemics , Clinical Trials as Topic/methods , Clinical Trials as Topic/organization & administration
10.
Pediatr Obes ; 18(5): e13010, 2023 05.
Article in English | MEDLINE | ID: mdl-36734672

ABSTRACT

BACKGROUND: Although the association between prenatal tobacco exposure and child obesity risk is well-established, less is known about co-exposure to tobacco and cannabis. OBJECTIVE: Determine the relation between prenatal substance co-exposure and obesity risk. METHODS: In a diverse sample of pregnant women, we examined the association between prenatal substance exposure (tobacco-only and co-exposure) and child BMI (kg/m2 ) trajectories from birth to mid-childhood (n = 262), overweight/obese status based on BMI percentiles from toddlerhood (24 months) to mid-childhood (9-12 years), and adiposity outcomes at mid-childhood (fat mass [kg], fat mass [%] and fat free mass [kg]; n = 128). Given that the major goal of this study was to examine the associations between prenatal substance exposure and child outcomes, we oversampled pregnant women for substance use (with tobacco as the primary focus). RESULTS: Multilevel models demonstrated that children in both exposure groups had a steeper increase in BMI trajectory from birth to mid-childhood and among co-exposed children, girls had a steeper increase than boys. Odds ratio of having obesity by mid-childhood was 12 times higher among those co-exposed than non-exposed. Co-exposure led to significantly greater fat mass and fat mass % compared with no exposure, but exposure to only tobacco was no different than no exposure. CONCLUSIONS: Results highlight potentiating effects of cannabis exposure in the context of maternal tobacco use in pregnancy on obesity risk and the importance of multi-method assessments of obesity.


Subject(s)
Cannabis , Pediatric Obesity , Prenatal Exposure Delayed Effects , Child , Male , Pregnancy , Female , Humans , Cannabis/adverse effects , Nicotiana/adverse effects , Pediatric Obesity/epidemiology , Pediatric Obesity/etiology , Overweight , Adiposity , Body Mass Index , Prenatal Exposure Delayed Effects/epidemiology
11.
JAMA Netw Open ; 5(11): e2241731, 2022 11 01.
Article in English | MEDLINE | ID: mdl-36367720

ABSTRACT

Importance: Even with varenicline, the leading monotherapy for tobacco dependence, smoking abstinence rates remain low. Preliminary evidence suggests that extending the duration of varenicline treatment before quitting may increase abstinence. Objective: To test the hypotheses that, compared with standard run-in varenicline treatment (1 week before quitting), extended run-in varenicline treatment (4 weeks before quitting) reduces smoking exposure before the target quit date (TQD) and enhances abstinence, particularly among women. Design, Setting, and Participants: This double-blind, randomized, placebo-controlled clinical trial enrolled participants from October 2, 2017, to December 9, 2020, at a single-site research clinic in Buffalo, New York. Of 1385 people screened, 320 adults reporting smoking 5 or more cigarettes per day (CPD) were randomized and followed up for 28 weeks. Data were analyzed from August 2021 to June 2022. Interventions: In the pre-TQD period (weeks 1-4), the extended run-in group received 4 weeks of varenicline; the standard run-in group received 3 weeks of placebo followed by 1 week of varenicline. Both groups received open-label varenicline during weeks 5 to 15 and brief quit counseling at 6 clinic visits. Main Outcomes and Measures: The primary outcome consisted of cotinine-verified (at end of treatment [EOT]) self-reported continuous abstinence from smoking (in CPD) during the last 4 weeks of treatment. Secondary outcomes included bioverified self-report of continuous abstinence at the 6-month follow-up and percentage of reduction in self-reported smoking rate during the prequit period (week 1 vs week 4). Results: A total of 320 participants were randomized, including 179 women (55.9%) and 141 men (44.1%), with a mean (SD) age of 53.7 (10.1) years. Continuous abstinence during the final 4 weeks of treatment (weeks 12-15; EOT) was not greater in the extended run-in group (64 of 163 [39.3%]) compared with the standard run-in group (57 of 157 [36.3%]; odds ratio [OR], 1.13 [95% CI, 0.72-1.78]), nor was the hypothesized group × sex interaction significant (OR, 0.52 [95% CI, 0.21-1.28]). Similar nonsignificant results were obtained for continuous abstinence at the 6-month follow-up. The mean (SE) decrease in self-reported smoking rate during the prequit period was greater in the extended run-in group (-38.8% [2.8%]) compared with the standard run-in group (-17.5% [2.7%]). Conclusions and Relevance: Among adult daily smokers, extending the duration of prequit varenicline treatment beyond the standard 1-week run-in period reduced prequit smoking exposure but, more importantly, did not significantly improve continuous abstinence rates. Trial Registration: ClinicalTrials.gov Identifier: NCT03262662.


Subject(s)
Nicotinic Agonists , Smoking Cessation , Female , Animals , Varenicline/therapeutic use , Nicotinic Agonists/therapeutic use , Smoking Cessation/methods , Benzazepines/therapeutic use , Quinoxalines/therapeutic use , Smoking/drug therapy , Smoking/epidemiology
12.
Nicotine Tob Res ; 24(12): 1914-1920, 2022 11 12.
Article in English | MEDLINE | ID: mdl-35906990

ABSTRACT

INTRODUCTION: Although treatment outcome expectancies (TOEs) may influence clinical outcomes, TOEs are rarely reported in the smoking cessation literature, in part because of the lack of validated measures. Therefore, we conducted a psychometric evaluation of TOEs scores with the Stanford Expectations of Treatment Scale (SETS) in the context of a smoking cessation clinical trial. METHODS: Participants were 320 adults enrolled in a randomized controlled trial of extended versus standard pre-quit varenicline treatment for smoking cessation (clinicaltrials.gov ID: NCT03262662). Across an 8-week treatment period, we examined the nature and stability of the factor structure using confirmatory factor analysis (CFA), evaluated discriminant validity by examining correlations with abstinence self-efficacy and positive/negative affect (PA/NA), and assessed internal consistency and test-retest reliability of SETS scores. RESULTS: CFAs supported a 2-factor structure that was stable (ie, invariant) across weeks. Positive and negative TOEs were each reflected in three-item subscales that exhibited acceptable to excellent internal consistency (Cronbach's alphas ≥ .77). Positive and negative TOEs were modestly correlated with PA and NA (all |rs| <.27, p < .05). Positive TOEs, but not negative TOEs, were moderately correlated with abstinence self-efficacy (rs = .45 to .61, p < .01). Both positive and negative TOEs scores demonstrated moderate test-retest reliability between assessments (rs = .54 to .72). CONCLUSIONS: SETS scores generally reflect a valid and reliable assessment of positive and negative TOEs in a sample of adults enrolled in a smoking cessation trial. The SETS appears to be a reasonable option for assessing TOEs in future smoking treatment studies. IMPLICATIONS: Assessments of treatment outcome expectancies are rarely reported in the smoking cessation literature. The present results support the validity and reliability of the SETS scores among adults seeking treatment for their smoking behavior.


Subject(s)
Smoking Cessation , Adult , Humans , Smoking Cessation/methods , Psychometrics , Reproducibility of Results , Motivation , Varenicline/therapeutic use
13.
Nicotine Tob Res ; 24(11): 1803-1810, 2022 10 26.
Article in English | MEDLINE | ID: mdl-35639828

ABSTRACT

INTRODUCTION: Negative reinforcement models posit that relapse to cigarette smoking is driven in part by changes in affect and craving during the quit attempt. Varenicline may aid cessation by attenuating these changes; however, this mediational pathway has not been formally evaluated in placebo-controlled trials. Thus, trajectories of negative affect (NA), positive affect (PA), and craving were tested as mediators of the effect of varenicline on smoking cessation. AIMS AND METHODS: Secondary data analysis was conducted on 828 adults assigned to either varenicline or placebo in a randomized controlled trial for smoking cessation (NCT01314001). Self-reported NA, PA, and craving were assessed 1-week pre-quit, on the target quit day (TQD), and 1 and 4 weeks post-TQD. RESULTS: Across time, NA peaked 1-week post-quit, PA did not change, and craving declined. Less steep rises in NA (indirect effect 95% CI: .01 to .30) and lower mean craving at 1-week post-quit (CI: .06 to .50) were mediators of the relationship between varenicline and higher cessation rates at the end of treatment. PA was associated with cessation but was not a significant mediator. CONCLUSIONS: These results partially support the hypothesis that varenicline improves smoking cessation rates by attenuating changes in specific psychological processes and supported NA and craving as plausible treatment mechanisms of varenicline. IMPLICATIONS: The present research provides the first evidence from a placebo-controlled randomized clinical trial that varenicline's efficacy is due, in part, to post-quit attenuation of NA and craving. Reducing NA across the quit attempt and craving early into the attempt may be important treatment mechanisms for effective interventions. Furthermore, post-quit NA, PA, and craving were all associated with relapse and represent treatment targets for future intervention development.


Subject(s)
Cigarette Smoking , Smoking Cessation , Adult , Humans , Varenicline/therapeutic use , Craving , Smoking Cessation/methods , Recurrence , Quinoxalines/therapeutic use , Benzazepines/therapeutic use
14.
Nicotine Tob Res ; 24(2): 270-274, 2022 02 01.
Article in English | MEDLINE | ID: mdl-34460924

ABSTRACT

INTRODUCTION: Varenicline is the most efficacious drug for smoking cessation; saliva varenicline concentrations can be useful for the evaluation of adherence in smoking cessation trials. Saliva is a useful noninvasive matrix for mail-in specimen collection, if stable. We investigated the stability of varenicline in saliva at different storage temperatures simulating the time it takes to mail in a sample. METHODS: We evaluated the concentrations of varenicline, nicotine, cotinine, 3'-hydroxycotinine, and 3'-hydroxycotinine/cotinine (3HC/COT) ratio in quality control saliva samples (and after repeated freezing and thawing), and in smokers' saliva samples, stored for up to 21 days at room temperature (~25°C), 4°C, and -80°C. RESULTS: In saliva quality control samples, concentrations of varenicline, nicotine, cotinine, 3'-hydroxycotinine, and 3HC/COT remained unchanged and showed little within-sample variation (CV ≤ 5.5%) for up to 21 days at the three storage temperatures; they were also not altered after three thaw-freeze cycles. In smokers' saliva, a significant main effect of storage duration, but not temperature, was observed for varenicline, cotinine, and 3'-hydroxycotinine, but not for nicotine or the 3HC/COT ratio. However, these changes were within analytical (i.e., equipment) variation resulting in little within-sample variation (CV ≤ 5.8%) for all analytes in smokers' saliva. CONCLUSIONS: Varenicline, the other analytes, and the 3HC/COT ratio remained stable in saliva during storage for 21 days at all temperatures tested and after repeated freezing and thawing with only minor changes in concentration over time. These findings support the potential use of mail-in approach for saliva samples in varenicline smoking cessation clinical trials. IMPLICATIONS: Assessing saliva varenicline concentrations can be useful for the evaluation of adherence in smoking cessation trials. Saliva is a noninvasive matrix suitable for mail-in specimen collection. This is the first investigation of stability of varenicline in saliva. Varenicline, nicotine, cotinine, 3'-hydroxycotinine, and 3HC/COT were stable in saliva for up to 21 days at room temperature (~25°C), 4°C, and -80°C, supporting the use of a mail-in approach for saliva specimen in smoking cessation trials.


Subject(s)
Saliva , Smoking Cessation , Cotinine , Humans , Nicotine , Temperature , Varenicline
15.
JMIR Form Res ; 5(4): e25541, 2021 Apr 30.
Article in English | MEDLINE | ID: mdl-33878020

ABSTRACT

BACKGROUND: The pandemic of SARS-CoV-2, which causes COVID-19, has caused disruptions in ongoing clinical trials and is expected to accelerate interest in conducting research studies remotely. OBJECTIVE: A quasi-experimental, mixed methods approach was used to examine the rates of visit completion as well as the opinions and experiences of participants enrolled in an ongoing clinical trial of smoking cessation who were required to change from in-person clinic visits to remote visits using video or telephone conferencing due to the COVID-19 pandemic. METHODS: For quantitative comparisons, we used a quasi-experimental design, comparing a cohort of participants followed during the pandemic (n=23, COVID-19 cohort) to a comparable cohort of participants followed over a similar time period in the calendar years 2018 and 2019 (n=51, pre-COVID-19 cohort) to examine the rates of completion of scheduled visits and biospecimen collection. For the qualitative component, interviews were conducted with participants who experienced the transition from in-person to remote visits. RESULTS: Participants in the COVID-19 cohort completed an average of 83.6% of remote clinic visits (95% CI 73.1%-91.2%), which was not significantly different than the in-person completion rate of 89.8% in the pre-COVID-19 cohort. Participants in the COVID-19 cohort returned an average of 93.2% (95% CI 83.5%-98.1%) of saliva specimens for remote clinic visits completed, which was not significantly different than the in-person saliva specimen completion rate of 100% in the pre-COVID-19 cohort. Two broad themes emerged from the qualitative data: (1) the benefits of remote visits and (2) the challenges of remote counseling compared to in-person counseling. Despite limited experience with telehealth prior to this transition, most participants expressed a willingness to engage in remote visits in the future. CONCLUSIONS: Even in the context of a rapid transition from in-person to remote visits necessitated by the COVID-19 pandemic, rates of visit completion and return of biospecimens remained high. Participants were generally accepting of the transition. Further research is needed to identify the optimal mix of in-person and remote visits beyond the pandemic context and to better understand how these changes may impact study outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT03262662; https://clinicaltrials.gov/ct2/show/study/NCT03262662.

16.
Am J Addict ; 30(4): 382-388, 2021 07.
Article in English | MEDLINE | ID: mdl-33772971

ABSTRACT

BACKGROUND AND OBJECTIVES: Persons with current or past major depressive disorder (MDD) vs those without have higher smoking rates. The nicotine metabolite ratio (NMR) represents variation in the rate of nicotine metabolism and has been associated with smoking behaviors and response to tobacco treatments. We compared NMR between smokers with current or past MDD (MDD+) vs smokers without MDD (MDD-). We also assessed correlates of NMR and compared withdrawal and craving between MDD+ and MDD- smokers. METHODS: Using baseline data from two clinical trials and propensity score weighting based on sex, race, body mass index, and smoking rate, we compared NMR between MDD+ (N = 279) and MDD- (N = 1575) smokers. We also compared groups on and nicotine withdrawal and craving. RESULTS: Mean NMR (ß = -.02, 95% confidence interval [CI]: -0.05 to 0.01, P = .13) and the distribution of smokers across NMR quartiles (odds ratio [OR] = 0.76, 95% CI: 0.50 to 1.16, P = .21) were similar between MDD+ and MDD- samples. This relationship was not affected by antidepressant medication. In the MDD+ sample, African Americans had significantly lower mean NMR, while older smokers and smokers with lower education had higher mean NMR (Ps < .05). MDD+ smokers had significantly higher withdrawal and craving than MDD- smokers (Ps < .05). DISCUSSION AND CONCLUSIONS: While variability in NMR may not explain differences in smoking rates between MDD+ and MDD- smokers, MDD+ smokers report increased withdrawal and craving. SCIENTIFIC SIGNIFICANCE: In this first study to assess NMR among MDD+ smokers, the findings underscore the need to address withdrawal and craving within smoking cessation treatments for those with MDD. (Am J Addict 2021;00:00-00).


Subject(s)
Depressive Disorder, Major/epidemiology , Nicotine/metabolism , Smokers/psychology , Smoking/epidemiology , Adult , Craving , Female , Humans , Male , Middle Aged , Smokers/statistics & numerical data , Smoking/psychology , Substance Withdrawal Syndrome/epidemiology
17.
Article in English | MEDLINE | ID: mdl-33435462

ABSTRACT

The consequences of the COVID-19 pandemic on behavioral health, including tobacco use, are not fully known. The current study sought to measure the perceived impact of COVID-19 and the resulting stay-at-home orders in Philadelphia, Pennsylvania and Buffalo, New York on smokers enrolled in four smoking cessation trials between March 2020 and July 2020. The survey collected quantitative data regarding life changes due to COVID-19, health/exposure status, and the impact on their cessation attempt (e.g., motivation to quit, change in triggers). The questionnaire collected qualitative data to better understand how such changes could explain changes in smoking behavior. Of the 42 participants surveyed, approximately half indicated that COVID-19 changed their motivation and ability to quit or remain quit. Among those who reported that it was easier to quit following the stay-at-home orders (n = 24), most attributed this to concerns regarding the severity of COVID-19 among smokers. Among those who reported more difficulty quitting (n = 15), most attributed this to their increased stress due to the pandemic and the inability to access activities, places, or people that could help them manage triggers. Given public health warnings of continued surges in COVID-19, these data provide insight into who may benefit from further smoking cessation support should existing restrictions or new stay-at-home orders be enacted.


Subject(s)
COVID-19 , Motivation , Patient Acceptance of Health Care/statistics & numerical data , Smokers , Smoking Cessation/statistics & numerical data , Humans , New York/epidemiology , Pandemics , Philadelphia/epidemiology , Surveys and Questionnaires
18.
Psychopharmacology (Berl) ; 238(2): 599-609, 2021 Feb.
Article in English | MEDLINE | ID: mdl-33219852

ABSTRACT

RATIONALE: Varenicline, a partial nicotinic agonist, is theorized to attenuate pre-quit smoking reinforcement and post-quit withdrawal and craving. However, the mechanisms of action have not been fully characterized, as most studies employ only retrospective self-report measures, hypothetical indices of reinforcing value, and/or nontreatment-seeking samples. OBJECTIVES: The current research examined the impact of pre-quit varenicline (vs. placebo) on laboratory measures of smoking and food (vs. water) reinforcement and craving. METHODS: Participants were 162 treatment-seeking smokers enrolled in a randomized controlled trial of smoking cessation ( clinicaltrials.gov ID: NCT03262662). Participants completed two laboratory sessions: a pre-treatment session, ~ 1 week prior to beginning varenicline or placebo, and an active treatment session, after ~ 3 weeks of treatment. At each session, participants completed a laboratory choice procedure; on each of 36 trials, a lit cigarette, food item, or cup of water was randomly presented. Participants reported level of craving and spent $0.01-0.25 to have a corresponding 5-95% chance to sample the cue. RESULTS: As predicted, spending was significantly higher on cigarette trials than water trials, and varenicline resulted in a greater between-session decline in spending on cigarette trials (but not water) than did placebo. Cigarette craving was enhanced in the presence of smoking cues compared to water, but neither average (tonic) cigarette craving nor cue-specific cigarette craving was significantly influenced by varenicline. Food spending and craving were generally unaffected by varenicline treatment. CONCLUSIONS: These laboratory data from treatment-seeking smokers provide the strongest evidence to date that varenicline selectively attenuates smoking reinforcement prior to quitting.


Subject(s)
Craving/drug effects , Nicotinic Agonists/pharmacology , Reinforcement, Psychology , Smoking Cessation/psychology , Smoking/psychology , Varenicline/pharmacology , Adult , Benzazepines/pharmacology , Cues , Double-Blind Method , Female , Humans , Laboratories , Male , Middle Aged , Quinoxalines/pharmacology , Retrospective Studies , Smokers/psychology , Smoking/drug therapy , Smoking Cessation/methods , Treatment Outcome
19.
Exp Clin Psychopharmacol ; 29(1): 82-89, 2021 Feb.
Article in English | MEDLINE | ID: mdl-32437192

ABSTRACT

Despite the growing interest in caffeine use and its effects among adolescents, and a large literature on caffeine and attention among adults, there is a lack of experimental work examining the impact of caffeine on sustained attention among adolescents. We evaluated the acute effects of caffeine (vs. placebo) during a long (33-min) classic vigilance task among 31 adolescents (aged 12-17; 15 female; median caffeine use = 28 mg/day). We predicted a dose-dependent effect of caffeine, which would attenuate declines in target detection over time (i.e., a vigilance decrement). In each of 3 visits, participants completed an identical pairs continuous performance task beginning ∼25 min after consumption of noncaloric flavored water containing placebo, 1 mg/kg, or 3 mg/kg caffeine (order counterbalanced). Percent hits for low probability targets across 12 100-trial blocks was the primary outcome measure. As predicted, the linear decline in hits across trial blocks was attenuated by caffeine (Caffeine vs. Placebo × Block Linear, p = .01), with significant improvements in Blocks 9-12 (ps < .03). Compared to 1 mg/kg, 3 mg/kg caffeine resulted in earlier improvement in target detection (Drug Dose × Block Quadratic, p = .001). This study demonstrated that caffeine acutely and dose-dependently improves sustained attention among adolescents. These results were likely due to the attention-enhancing effect of caffeine, rather than withdrawal reversal, as our sample was characterized by light to moderate caffeine use. This study provides the foundation for further work on the impact of chronic caffeine consumption on cognitive function during adolescence. (PsycInfo Database Record (c) 2021 APA, all rights reserved).


Subject(s)
Adolescent Behavior/drug effects , Adolescent Behavior/psychology , Attention/drug effects , Caffeine/administration & dosage , Central Nervous System Stimulants/administration & dosage , Psychomotor Performance/drug effects , Adolescent , Adolescent Behavior/physiology , Attention/physiology , Child , Cognition/drug effects , Cognition/physiology , Double-Blind Method , Female , Humans , Male , Neuropsychological Tests , Psychomotor Performance/physiology , Reaction Time/drug effects , Reaction Time/physiology
20.
Dev Psychopathol ; 33(1): 29-46, 2021 02.
Article in English | MEDLINE | ID: mdl-32308172

ABSTRACT

Given the equivocal literature on the relationship between internalizing symptoms and early adolescent alcohol use (AU) and AU disorder (AUD), the present study took a developmental perspective to understand how internalizing and externalizing symptoms may operate together in the etiology of AU and AUD. We pit the delayed onset and rapid escalation hypothesis (Hussong et al., 2011) against a synthesis of the dual failure model and the stable co-occurring hypothesis (Capaldi, 1992; Colder et al., 2013, 2018) to test competing developmental pathways to adolescent AU and AUD involving problem behavior, peer delinquency, and early initiation of AU. A latent transactional and mediational framework was used to test pathways to AUD spanning developmental periods before AU initiation (Mage = 11) to early and high risk for AUD (Mage = 14-15 and Mage = 17-18). The results supported three pathways to AUD. The first started with "pure" externalizing symptoms in early childhood and involved multiple mediators, including the subsequent development of co-occurring symptoms and peer delinquency. The second pathway involved stable co-occurring symptoms. Interestingly, chronically elevated pure internalizing symptoms did not figure prominently in pathways to AUD. Selection and socialization effects between early AU and peer delinquency constituted a third pathway.


Subject(s)
Alcoholism , Problem Behavior , Underage Drinking , Adolescent , Child , Child, Preschool , Humans , Peer Group , Risk Factors
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