Pinney Associates Inc.

North Bethesda, MD, United States

Pinney Associates Inc.

North Bethesda, MD, United States
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Stiles M.F.,RAI Services Company | Campbell L.R.,RAI Services Company | Graff D.W.,Celerion | Jones B.A.,RAI Services Company | And 2 more authors.
Psychopharmacology | Year: 2017

Rationale: Electronic cigarettes (ECs) are becoming popular alternatives for smokers, but there has been limited study of their abuse liability. Objectives: The objective of this study was to evaluate the abuse liability of three Vuse Solo ECs, ranging from 14 to 36 mg in nicotine content, relative to high- and low-abuse liability comparator products (usual brand combustible cigarettes and nicotine gum, respectively) in a group of 45 EC-naïve smokers. Methods: Enrolled subjects’ ratings of subjective effects and nicotine uptake over 6 h were used to measure abuse liability and pharmacokinetics following in-clinic use of each EC. Results: Use of Vuse Solo resulted in subjective measures and nicotine uptake that were between those of combustible cigarettes and nicotine gum, although generally closer to nicotine gum. Compared to combustible cigarettes, use of Vuse Solo resulted in significantly lower scores in measures of product liking, positive effects, and intent to use again. These pharmacodynamic findings were consistent with the pharmacokinetic data, showing that cigarettes produced substantially faster and higher levels of nicotine uptake as compared to Vuse Solo and nicotine gum. Vuse Solo resulted in more rapid initial uptake of nicotine compared to nicotine gum, but peak concentration and long-term extent of uptake were not different or were lower with Vuse. Conclusions: Collectively, these findings suggest that Vuse Solo likely has an abuse liability that is somewhat greater than nicotine gum but lower than cigarettes. Trial registration: ClinicalTrials.govidentifier: NCT02269514 © 2017 The Author(s)


Zapawa L.M.,Pinney Associates Inc. | Hughes J.R.,University of Vermont | Benowitz N.L.,University of California at San Francisco | Rigotti N.A.,Massachusetts General Hospital | And 2 more authors.
Addictive Behaviors | Year: 2011

Background: FDA-approved labeling for over-the-counter (OTC) nicotine replacement therapy (NRT) limits duration of use to a relatively short period of time (10-12. weeks) and explicitly advises against NRT use while smoking or with additional forms of NRT. Objective: To consider and summarize evidence accumulated since the OTC label was created regarding the safety and efficacy of longer-term and concomitant use to provide recommendations regarding these uses. Method: Literature searches were conducted on Medline, journal websites, and Internet search engines, with findings reviewed by six smoking cessation researchers. Results: Persistent (i.e., long-term) use of NRT does not appear harmful and self-selected persistent use is primarily driven by concerns about relapse to smoking, not addiction. Similarly, continued use of NRT and tobacco during a lapse or relapse and combination NRT treatment do not appear harmful and appear to enhance efficacy. Conclusions: Persistent users of NRT should be counseled to reduce and stop NRT only when they are not concerned about relapsing to smoking. Use of NRT with return to smoking during a lapse or relapse should not be automatically discontinued. Combination NRT therapy should be considered for all smokers, especially those who are unable to quit smoking using a single form of NRT. © 2010 Elsevier Ltd.


Ferguson S.G.,Menzies Research Institute | Gitchell J.G.,Pinney Associates Inc. | Shiffman S.,Pinney Associates Inc. | Shiffman S.,University of Pittsburgh
Addiction | Year: 2012

Aims Smokers who lapse during a cessation attempt are at particularly high risk of relapse, so interventions to help smokers recover from lapses are urgently needed. Two recent studies have suggested continuing to use nicotine patches following a lapse may be a beneficial relapse prevention strategy. However, to date no study that uses approved doses of nicotine patches under real-world conditions has tested this hypothesis. Design and setting Clinical trial conducted across eight US study sites. Participants and measurements Using data from 509 subjects (240 active; 269 placebo) who lapsed during weeks 3-5 of treatment in a randomized, double-blind placebo-controlled trial of 21-mg nicotine patches, we examined whether active nicotine patch use improved the chances of recovering abstinence (7-day point-prevalence) at weeks 6 and 10. Findings Active patch use (versus placebo) increased the likelihood of recovery from a lapse both at 6 weeks [8.3% versus 0.8%; relative risk (RR)=11.0, P<0.001] and at 10 weeks (9.6% versus 2.6%; RR=3.7, P<0.001). Conclusions Continuing treatment to aid smoking cessation with active patches promotes recovery from lapses. Smokers should be encouraged to persist with patch treatment if they lapse to smoking. © 2012 Society for the Study of Addiction.


Shiffman S.,Pinney Associates Inc | Gerlach K.K.,Pinney Associates Inc | Sembower M.A.,Pinney Associates Inc | Rohay J.M.,Pinney Associates Inc
Annals of Pharmacotherapy | Year: 2011

BACKGROUND: Patient education and warnings have emerged as prominent interventions for improving drug safety. As part of the provision of information and guidance on safe use of drugs, patients often receive multiple pieces of written information when they obtain a prescription medication, including a Food and Drug Administration (FDA)-mandated medication guide (MG), consumer medication information (CMI), and patient package insert (PPI). OBJECTIVE: To determine whether patients understand the materials providing drug information and whether the materials convey the intended information. METHODS: Fifty-two adults with a high school education or less were shown an actual (blinded) MG, CMI, and PPI for a marketed antidepressant medication. Comprehension was tested with methods used by the FDA to assess label comprehension for nonprescription products. RESULTS: The majority of participants (88.2%) looked at all 3 pieces of information provided. The mean (SD) time spent reviewing the CMI was 5.2 (4.8) minutes (range 0-21.9), 16.5 (13.3) minutes for the PPI (range 0-43.0), and 2.5 (1.6) minutes for the MG (range 0-7.6). Less than 20% of participants were able to identify the symptoms of a rare but potentially life-threatening situation that can occur with this medication and only 61.5% recalled the risk of teen suicide, which is the sole focus of the MG. Respondents with lower literacy scores performed more poorly than those with higher literacy scores. CONCLUSIONS: Information provided with at least some prescription drugs is not adequately understood by less-educated consumers and does not effectively communicate critical safety messages or directions.


Sweeney C.T.,Pinney Associates Inc. | Sembower M.A.,Pinney Associates Inc. | Ertischek M.D.,Pinney Associates Inc. | Shiffman S.,Pinney Associates Inc. | Schnoll S.H.,Pinney Associates Inc.
Journal of Addictive Diseases | Year: 2013

Multidrug use is well documented among nonmedical users of prescription stimulants. We sought to provide insight into the drug use patterns of those reporting nonmedical use of prescription attention-deficit hyperactivity disorder (ADHD) stimulants in an attempt to discern whether such use is a first step in a pattern of drug-abusing behavior or, conversely, is a later development accompanied or preceded by a history of drug abuse. A cross-sectional, population-based survey of the U.S. civilian, non-institutionalized population aged 12 years and older was analyzed for lifetime nonmedical use of prescription ADHD stimulants, lifetime nonmedical use of another prescription drug, illicit drug use, and drug use initiation patterns. This included 443,041 respondents from the 2002-2009 National Survey on Drug Use and Health. Lifetime nonmedical use of prescription ADHD stimulants was reported by 3.4% of those aged 12 years and older. Of these, 95.3% also reported use of an illicit drug (i.e., marijuana, cocaine/crack, heroin, hallucinogens, inhalants) or nonmedical use of another prescription drug (i.e., tranquilizers, pain relievers, or sedatives), and such use preceded nonmedical use of prescription ADHD stimulants in 77.6% of cases. On average, 2.40 drugs were used prior to the first nonmedical use of prescription ADHD stimulants. These data suggest that nonmedical use of prescription ADHD stimulants is not commonly an initiating factor leading to the nonmedical use of other prescription medications or abuse of illicit drugs. Rather, nonmedical use of prescription ADHD stimulants appears to be adopted by individuals already engaged in broader patterns of drug abuse and misuse. © 2013 Copyright Taylor and Francis Group, LLC.


PubMed | Pinney Associates Inc.
Type: Journal Article | Journal: Addictive behaviors | Year: 2011

FDA-approved labeling for over-the-counter (OTC) nicotine replacement therapy (NRT) limits duration of use to a relatively short period of time (10-12 weeks) and explicitly advises against NRT use while smoking or with additional forms of NRT.To consider and summarize evidence accumulated since the OTC label was created regarding the safety and efficacy of longer-term and concomitant use to provide recommendations regarding these uses.Literature searches were conducted on Medline, journal websites, and Internet search engines, with findings reviewed by six smoking cessation researchers.Persistent (i.e., long-term) use of NRT does not appear harmful and self-selected persistent use is primarily driven by concerns about relapse to smoking, not addiction. Similarly, continued use of NRT and tobacco during a lapse or relapse and combination NRT treatment do not appear harmful and appear to enhance efficacy.Persistent users of NRT should be counseled to reduce and stop NRT only when they are not concerned about relapsing to smoking. Use of NRT with return to smoking during a lapse or relapse should not be automatically discontinued. Combination NRT therapy should be considered for all smokers, especially those who are unable to quit smoking using a single form of NRT.


PubMed | Pinney Associates Inc.
Type: Journal Article | Journal: The Annals of pharmacotherapy | Year: 2011

Patient education and warnings have emerged as prominent interventions for improving drug safety. As part of the provision of information and guidance on safe use of drugs, patients often receive multiple pieces of written information when they obtain a prescription medication, including a Food and Drug Administration (FDA)-mandated medication guide (MG), consumer medication information (CMI), and patient package insert (PPI).To determine whether patients understand the materials providing drug information and whether the materials convey the intended information.Fifty-two adults with a high school education or less were shown an actual (blinded) MG, CMI, and PPI for a marketed antidepressant medication. Comprehension was tested with methods used by the FDA to assess label comprehension for nonprescription products.The majority of participants (88.2%) looked at all 3 pieces of information provided. The mean (SD) time spent reviewing the CMI was 5.2 (4.8) minutes (range 0-21.9), 16.5 (13.3) minutes for the PPI (range 0-43.0), and 2.5 (1.6) minutes for the MG (range 0-7.6). Less than 20% of participants were able to identify the symptoms of a rare but potentially life-threatening situation that can occur with this medication and only 61.5% recalled the risk of teen suicide, which is the sole focus of the MG. Respondents with lower literacy scores performed more poorly than those with higher literacy scores.Information provided with at least some prescription drugs is not adequately understood by less-educated consumers and does not effectively communicate critical safety messages or directions.

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