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Research paper thumbnail of Alteration of Autophagy and Glial Activity in Nilotinib-Treated Huntington’s Disease Patients

Metabolites

Nilotinib is a tyrosine kinase inhibitor that is safe and tolerated in neurodegeneration, it achi... more Nilotinib is a tyrosine kinase inhibitor that is safe and tolerated in neurodegeneration, it achieves CSF concentration that is adequate to inhibit discoidin domain receptor (DDR)-1. Nilotinib significantly affects dopamine metabolites, including Homovanillic acid (HVA), resulting in an increase in brain dopamine. HD is a hereditary disease caused by mutations in the Huntingtin’s (HTT) gene and characterized by neurodegeneration and motor and behavioral symptoms that are associated with activation of dopamine receptors. We explored the effects of a low dose of nilotinib (150 mg) on behavioral changes and motor symptoms in manifest HD patients and examined the effects of nilotinib on several brain mechanisms, including dopamine transmission and gene expression via cerebrospinal fluid (CSF) miRNA sequencing. Nilotinib, 150 mg, did not result in any behavioral changes, although it significantly attenuated HVA levels, suggesting reduction of dopamine catabolism. There was no significant...

Research paper thumbnail of H41 How can clinical trials and outreach contribute to patient care outcomes in Huntington’s disease?

H: Clinical care and clinical services

Research paper thumbnail of Correction to Reduced nicotine content cigarettes in smokers of low socioeconomic status: study protocol for a randomized control trial

Trials, Jan 15, 2017

The title of the original publication [1] had an error; furthermore there were errors in Fig. 2. ... more The title of the original publication [1] had an error; furthermore there were errors in Fig. 2. The corrected version of the title and of Fig. 2 can be found below in this Erratum.

Research paper thumbnail of Reduced nicotine content cigarettes in smokers of low socioeconomic status: study protocol for a randomized control trial

Trials, Jan 3, 2017

The Family Smoking Prevention and Tobacco Control Act gave the Food and Drug Administration juris... more The Family Smoking Prevention and Tobacco Control Act gave the Food and Drug Administration jurisdiction over the regulation of all tobacco products, including their nicotine content. Under this act, a major strategy to reduce harm from cigarette tobacco is lowering the nicotine content without causing unintended adverse consequences. Initial research on reduced nicotine content (RNC) cigarettes has shown that smokers of these cigarettes gradually decrease their smoking frequency and biomarkers of exposure. The effectiveness of this strategy needs to be demonstrated in different populations whose response to RNC cigarettes might be substantially mediated by personal or environmental factors, such as low socioeconomic status (SES) populations. This study aims to evaluate the response to a reduced nicotine intervention in low SES smokers, as defined here as those with less than 16 years of education, by switching smokers from high nicotine commercial cigarettes to RNC cigarettes. Adul...

Research paper thumbnail of Additional file 1: of Reduced nicotine content cigarettes in smokers of low socioeconomic status: study protocol for a randomized control trial

SPIRIT 2013 checklist: recommended items to address in a clinical trial protocol and related docu... more SPIRIT 2013 checklist: recommended items to address in a clinical trial protocol and related documents. (DOC 121 kb)

Research paper thumbnail of Additional file 1: of Correction to Reduced nicotine content cigarettes in smokers of low socioeconomic status: study protocol for a randomized control trial

SPIRIT figure. (DOCX 48 kb)

Research paper thumbnail of Switching to Progressively Reduced Nicotine Content Cigarettes in Smokers With Low Socioeconomic Status: A Double-Blind Randomized Clinical Trial

Nicotine & Tobacco Research

Introduction The Food and Drug Administration issued an advanced notice of proposed rulemaking fo... more Introduction The Food and Drug Administration issued an advanced notice of proposed rulemaking for setting a product standard for nicotine levels in cigarettes, with an emphasis on minimally or non-addicting very low nicotine content (VLNC). Methods A 33 week, two-arm, double-blind randomized trial conducted in Hershey, Pennsylvania, USA and Washington, DC, USA included adult daily cigarette smokers (≥5 cigarettes per day) with less than a college degree, and who had no plans to quit within the next six months. Participants were randomized to either reduced nicotine content (RNC) study cigarettes tapered every three weeks to a final VLNC (0.2 mg/cigarette) for six weeks or to usual nicotine content (UNC) study cigarettes (11.6 mg/cigarette). Outcomes included acceptability of study cigarettes measured by attrition (primary outcome), compliance, reduction in cigarette dependence and tobacco biomarkers, and post-intervention cessation. Results The RNC (n = 122) versus UNC (n = 123) gr...

Research paper thumbnail of Lesbian , Gay , Bisexual , and Transgendered Health

The LGBT community faces a large variety of mental and bodily health issues, as well as a need fo... more The LGBT community faces a large variety of mental and bodily health issues, as well as a need for cultural acceptance, that differs from the general population. This paper will provide a literature review of some of these issues, including stigma, HIV, and mental health, in order to provide the reader with a broader understanding of the complexities of being LGBT and a knowledge of where further research is needed. This paper does not focus on one geographic region, but rather looks at global case studies in order to provide the reader with a strong introduction to these issues.

Research paper thumbnail of F11 Prevalence of cigarette smoking in huntington’s disease

Clinical studies

Background There is some evidence that Huntington’s Disease (HD) patients are more likely to cons... more Background There is some evidence that Huntington’s Disease (HD) patients are more likely to consume cigarettes than the general population. Aims To compare the prevalence of cigarette smoking within four different groups of Enroll-HD subjects (manifest HD, pre-manifest HD, genotype negative, and family controls) and to compare Unified Huntington’s Disease Rating Scale Total Motor Score (UHDRS-TMS) between smokers and non-smokers to determine whether motor symptom level is related to cigarette use. Methods/techniques The percentage of smokers versus non-smokers within each group of Enroll-HD subjects was calculated. ‘Smoker’ was defined as any participant who used 1 or more cigarettes daily in the past year. Percentage of smokers within all gene negative groups combined was also calculated. A p-value hypothesis test was done to test statistical significance. The average TMS score on the UHDRS motor exam was calculated for both smokers and non-smokers and a two-tailed, two sample unequal variance t-test was done. Results/outcome The percentage of smokers within manifest HD, pre-manifest HD, genotype negative, and family control groups were 25.8%, 22.7%, 18.5%, and 15.6%, respectively (p-value<0.0000007) The percentage of smokers in all HD negative groups combined was 19.6% (p-value<0.000004) The average TMS score was 35.98 for smokers and 40.91 for non-smokers. The results of the t-test were 0.0000005296. Conclusions It was determined that there is a statistically significant difference between the number of smokers in each Enroll-HD group, and that the prevalence of smokers within HD-manifest patients is significantly higher. It was also determined that non-smokers had more motor symptoms, on average. It is unclear from these data whether this difference comes from patients who quit smoking because of HD motor symptoms or if smokers are more likely to seek medical care.

Research paper thumbnail of Clinical trial recruitment of adult African American smokers from economically disadvantaged urban communities

Journal of ethnicity in substance abuse, Jan 28, 2018

This investigation evaluated the effectiveness and challenges of multiple recruitment methods, de... more This investigation evaluated the effectiveness and challenges of multiple recruitment methods, described as proactive, reactive, and combination methods, among adult African American smokers (N = 527) from economically disadvantaged urban communities enrolled to test progressively reduced nicotine content investigational cigarettes. The study evaluated success using descriptive statistics to measure the volume of phone calls and percentage of eligible participants per method. Reactive and combination strategies effectively prompted participants to call about the study. Combination methods yielded the highest eligibility rates. Findings demonstrate the unique recruitment successes within this population across a range of recruitment methods and may inform improved methods to recruit and engage African Americans in clinical trials.

Research paper thumbnail of Correction to Reduced nicotine content cigarettes in smokers of low socioeconomic status: study protocol for a randomized control trial

Trials, Jan 15, 2017

The title of the original publication [1] had an error; furthermore there were errors in Fig. 2. ... more The title of the original publication [1] had an error; furthermore there were errors in Fig. 2. The corrected version of the title and of Fig. 2 can be found below in this Erratum.

Research paper thumbnail of Journal of Ethnicity in Substance Abuse Clinical trial recruitment of adult African American smokers from economically disadvantaged urban communities

This investigation evaluated the effectiveness and challenges of multiple recruitment methods, de... more This investigation evaluated the effectiveness and challenges of multiple recruitment methods, described as proactive, reactive, and combination methods, among adult African American smokers (N¼527) from economically disadvantaged urban communities enrolled to test progressively reduced nicotine content investigational cigarettes. The study evaluated success using descriptive statistics to measure the volume of phone calls and percentage of eligible participants per method. Reactive and combination strategies effectively prompted participants to call about the study. Combination methods yielded the highest eligibility rates. Findings demonstrate the unique recruitment successes within this population across a range of recruitment methods and may inform improved methods to recruit and engage African Americans in clinical trials.

Research paper thumbnail of Reduced nicotine content cigarettes in smokers of low socioeconomic status: study protocol for a randomized control trial

Background: The Family Smoking Prevention and Tobacco Control Act gave the Food and Drug Administ... more Background: The Family Smoking Prevention and Tobacco Control Act gave the Food and Drug Administration jurisdiction over the regulation of all tobacco products, including their nicotine content. Under this act, a major strategy to reduce harm from cigarette tobacco is lowering the nicotine content without causing unintended adverse consequences. Initial research on reduced nicotine content (RNC) cigarettes has shown that smokers of these cigarettes gradually decrease their smoking frequency and biomarkers of exposure. The effectiveness of this strategy needs to be demonstrated in different populations whose response to RNC cigarettes might be substantially mediated by personal or environmental factors, such as low socioeconomic status (SES) populations. This study aims to evaluate the response to a reduced nicotine intervention in low SES smokers, as defined here as those with less than 16 years of education, by switching smokers from high nicotine commercial cigarettes to RNC cigarettes.

Research paper thumbnail of Alteration of Autophagy and Glial Activity in Nilotinib-Treated Huntington’s Disease Patients

Metabolites

Nilotinib is a tyrosine kinase inhibitor that is safe and tolerated in neurodegeneration, it achi... more Nilotinib is a tyrosine kinase inhibitor that is safe and tolerated in neurodegeneration, it achieves CSF concentration that is adequate to inhibit discoidin domain receptor (DDR)-1. Nilotinib significantly affects dopamine metabolites, including Homovanillic acid (HVA), resulting in an increase in brain dopamine. HD is a hereditary disease caused by mutations in the Huntingtin’s (HTT) gene and characterized by neurodegeneration and motor and behavioral symptoms that are associated with activation of dopamine receptors. We explored the effects of a low dose of nilotinib (150 mg) on behavioral changes and motor symptoms in manifest HD patients and examined the effects of nilotinib on several brain mechanisms, including dopamine transmission and gene expression via cerebrospinal fluid (CSF) miRNA sequencing. Nilotinib, 150 mg, did not result in any behavioral changes, although it significantly attenuated HVA levels, suggesting reduction of dopamine catabolism. There was no significant...

Research paper thumbnail of H41 How can clinical trials and outreach contribute to patient care outcomes in Huntington’s disease?

H: Clinical care and clinical services

Research paper thumbnail of Correction to Reduced nicotine content cigarettes in smokers of low socioeconomic status: study protocol for a randomized control trial

Trials, Jan 15, 2017

The title of the original publication [1] had an error; furthermore there were errors in Fig. 2. ... more The title of the original publication [1] had an error; furthermore there were errors in Fig. 2. The corrected version of the title and of Fig. 2 can be found below in this Erratum.

Research paper thumbnail of Reduced nicotine content cigarettes in smokers of low socioeconomic status: study protocol for a randomized control trial

Trials, Jan 3, 2017

The Family Smoking Prevention and Tobacco Control Act gave the Food and Drug Administration juris... more The Family Smoking Prevention and Tobacco Control Act gave the Food and Drug Administration jurisdiction over the regulation of all tobacco products, including their nicotine content. Under this act, a major strategy to reduce harm from cigarette tobacco is lowering the nicotine content without causing unintended adverse consequences. Initial research on reduced nicotine content (RNC) cigarettes has shown that smokers of these cigarettes gradually decrease their smoking frequency and biomarkers of exposure. The effectiveness of this strategy needs to be demonstrated in different populations whose response to RNC cigarettes might be substantially mediated by personal or environmental factors, such as low socioeconomic status (SES) populations. This study aims to evaluate the response to a reduced nicotine intervention in low SES smokers, as defined here as those with less than 16 years of education, by switching smokers from high nicotine commercial cigarettes to RNC cigarettes. Adul...

Research paper thumbnail of Additional file 1: of Reduced nicotine content cigarettes in smokers of low socioeconomic status: study protocol for a randomized control trial

SPIRIT 2013 checklist: recommended items to address in a clinical trial protocol and related docu... more SPIRIT 2013 checklist: recommended items to address in a clinical trial protocol and related documents. (DOC 121 kb)

Research paper thumbnail of Additional file 1: of Correction to Reduced nicotine content cigarettes in smokers of low socioeconomic status: study protocol for a randomized control trial

SPIRIT figure. (DOCX 48 kb)

Research paper thumbnail of Switching to Progressively Reduced Nicotine Content Cigarettes in Smokers With Low Socioeconomic Status: A Double-Blind Randomized Clinical Trial

Nicotine & Tobacco Research

Introduction The Food and Drug Administration issued an advanced notice of proposed rulemaking fo... more Introduction The Food and Drug Administration issued an advanced notice of proposed rulemaking for setting a product standard for nicotine levels in cigarettes, with an emphasis on minimally or non-addicting very low nicotine content (VLNC). Methods A 33 week, two-arm, double-blind randomized trial conducted in Hershey, Pennsylvania, USA and Washington, DC, USA included adult daily cigarette smokers (≥5 cigarettes per day) with less than a college degree, and who had no plans to quit within the next six months. Participants were randomized to either reduced nicotine content (RNC) study cigarettes tapered every three weeks to a final VLNC (0.2 mg/cigarette) for six weeks or to usual nicotine content (UNC) study cigarettes (11.6 mg/cigarette). Outcomes included acceptability of study cigarettes measured by attrition (primary outcome), compliance, reduction in cigarette dependence and tobacco biomarkers, and post-intervention cessation. Results The RNC (n = 122) versus UNC (n = 123) gr...

Research paper thumbnail of Lesbian , Gay , Bisexual , and Transgendered Health

The LGBT community faces a large variety of mental and bodily health issues, as well as a need fo... more The LGBT community faces a large variety of mental and bodily health issues, as well as a need for cultural acceptance, that differs from the general population. This paper will provide a literature review of some of these issues, including stigma, HIV, and mental health, in order to provide the reader with a broader understanding of the complexities of being LGBT and a knowledge of where further research is needed. This paper does not focus on one geographic region, but rather looks at global case studies in order to provide the reader with a strong introduction to these issues.

Research paper thumbnail of F11 Prevalence of cigarette smoking in huntington’s disease

Clinical studies

Background There is some evidence that Huntington’s Disease (HD) patients are more likely to cons... more Background There is some evidence that Huntington’s Disease (HD) patients are more likely to consume cigarettes than the general population. Aims To compare the prevalence of cigarette smoking within four different groups of Enroll-HD subjects (manifest HD, pre-manifest HD, genotype negative, and family controls) and to compare Unified Huntington’s Disease Rating Scale Total Motor Score (UHDRS-TMS) between smokers and non-smokers to determine whether motor symptom level is related to cigarette use. Methods/techniques The percentage of smokers versus non-smokers within each group of Enroll-HD subjects was calculated. ‘Smoker’ was defined as any participant who used 1 or more cigarettes daily in the past year. Percentage of smokers within all gene negative groups combined was also calculated. A p-value hypothesis test was done to test statistical significance. The average TMS score on the UHDRS motor exam was calculated for both smokers and non-smokers and a two-tailed, two sample unequal variance t-test was done. Results/outcome The percentage of smokers within manifest HD, pre-manifest HD, genotype negative, and family control groups were 25.8%, 22.7%, 18.5%, and 15.6%, respectively (p-value<0.0000007) The percentage of smokers in all HD negative groups combined was 19.6% (p-value<0.000004) The average TMS score was 35.98 for smokers and 40.91 for non-smokers. The results of the t-test were 0.0000005296. Conclusions It was determined that there is a statistically significant difference between the number of smokers in each Enroll-HD group, and that the prevalence of smokers within HD-manifest patients is significantly higher. It was also determined that non-smokers had more motor symptoms, on average. It is unclear from these data whether this difference comes from patients who quit smoking because of HD motor symptoms or if smokers are more likely to seek medical care.

Research paper thumbnail of Clinical trial recruitment of adult African American smokers from economically disadvantaged urban communities

Journal of ethnicity in substance abuse, Jan 28, 2018

This investigation evaluated the effectiveness and challenges of multiple recruitment methods, de... more This investigation evaluated the effectiveness and challenges of multiple recruitment methods, described as proactive, reactive, and combination methods, among adult African American smokers (N = 527) from economically disadvantaged urban communities enrolled to test progressively reduced nicotine content investigational cigarettes. The study evaluated success using descriptive statistics to measure the volume of phone calls and percentage of eligible participants per method. Reactive and combination strategies effectively prompted participants to call about the study. Combination methods yielded the highest eligibility rates. Findings demonstrate the unique recruitment successes within this population across a range of recruitment methods and may inform improved methods to recruit and engage African Americans in clinical trials.

Research paper thumbnail of Correction to Reduced nicotine content cigarettes in smokers of low socioeconomic status: study protocol for a randomized control trial

Trials, Jan 15, 2017

The title of the original publication [1] had an error; furthermore there were errors in Fig. 2. ... more The title of the original publication [1] had an error; furthermore there were errors in Fig. 2. The corrected version of the title and of Fig. 2 can be found below in this Erratum.

Research paper thumbnail of Journal of Ethnicity in Substance Abuse Clinical trial recruitment of adult African American smokers from economically disadvantaged urban communities

This investigation evaluated the effectiveness and challenges of multiple recruitment methods, de... more This investigation evaluated the effectiveness and challenges of multiple recruitment methods, described as proactive, reactive, and combination methods, among adult African American smokers (N¼527) from economically disadvantaged urban communities enrolled to test progressively reduced nicotine content investigational cigarettes. The study evaluated success using descriptive statistics to measure the volume of phone calls and percentage of eligible participants per method. Reactive and combination strategies effectively prompted participants to call about the study. Combination methods yielded the highest eligibility rates. Findings demonstrate the unique recruitment successes within this population across a range of recruitment methods and may inform improved methods to recruit and engage African Americans in clinical trials.

Research paper thumbnail of Reduced nicotine content cigarettes in smokers of low socioeconomic status: study protocol for a randomized control trial

Background: The Family Smoking Prevention and Tobacco Control Act gave the Food and Drug Administ... more Background: The Family Smoking Prevention and Tobacco Control Act gave the Food and Drug Administration jurisdiction over the regulation of all tobacco products, including their nicotine content. Under this act, a major strategy to reduce harm from cigarette tobacco is lowering the nicotine content without causing unintended adverse consequences. Initial research on reduced nicotine content (RNC) cigarettes has shown that smokers of these cigarettes gradually decrease their smoking frequency and biomarkers of exposure. The effectiveness of this strategy needs to be demonstrated in different populations whose response to RNC cigarettes might be substantially mediated by personal or environmental factors, such as low socioeconomic status (SES) populations. This study aims to evaluate the response to a reduced nicotine intervention in low SES smokers, as defined here as those with less than 16 years of education, by switching smokers from high nicotine commercial cigarettes to RNC cigarettes.