RATIONALE: Nicotine replacement therapies (NRT) have been evaluated to facilitate cigarette smoking reduction in smokers unwilling or unable to quit. In most of these studies, only conventional doses of NRT have been tested and higher doses may be required to result in significant reductions in smoking and in biomarkers of exposure. OBJECTIVE: To determine if higher NRT doses in conjunction with smoking are safe and may promote significant reductions in cigarette smoking and biomarkers of exposure. METHODS: A dose-ranging, within-subject design was implemented to evaluate the effects of 15, 30 and 45 mg nicotine-patch treatment on measures of safety and the extent of smoking reduction and biomarker exposure per cigarette in smokers (N=20 completers) not immediately interested in quitting. RESULTS: Concurrent smoking and NRT were generally tolerated and resulted in no changes in blood pressure or heart rate. Slightly less than 10% of the study sample was not given the highest dose of NRT due to side effects. Self-reported cigarette smoking decreased with increasing doses of nicotine replacement and significant reductions were observed for total NNAL (a carcinogen biomarker) and carbon monoxide. However, even at the 45 mg dose, increased carbon monoxide and total NNAL per cigarette occurred, even though cotinine levels increased on average, 69.3% from baseline. CONCLUSIONS: The present results suggest that the use of high dose NRT is safe, leads to significant reductions in smoking (-49%), significant but less reductions in total NNAL (-24%) and carbon monoxide (-37%) due to compensatory smoking.
RATIONALE: Nicotine replacement therapies (NRT) have been evaluated to facilitate cigarette smoking reduction in smokers unwilling or unable to quit. In most of these studies, only conventional doses of NRT have been tested and higher doses may be required to result in significant reductions in smoking and in biomarkers of exposure. OBJECTIVE: To determine if higher NRT doses in conjunction with smoking are safe and may promote significant reductions in cigarette smoking and biomarkers of exposure. METHODS: A dose-ranging, within-subject design was implemented to evaluate the effects of 15, 30 and 45 mg nicotine-patch treatment on measures of safety and the extent of smoking reduction and biomarker exposure per cigarette in smokers (N=20 completers) not immediately interested in quitting. RESULTS: Concurrent smoking and NRT were generally tolerated and resulted in no changes in blood pressure or heart rate. Slightly less than 10% of the study sample was not given the highest dose of NRT due to side effects. Self-reported cigarette smoking decreased with increasing doses of nicotine replacement and significant reductions were observed for total NNAL (a carcinogen biomarker) and carbon monoxide. However, even at the 45 mg dose, increased carbon monoxide and total NNAL per cigarette occurred, even though cotinine levels increased on average, 69.3% from baseline. CONCLUSIONS: The present results suggest that the use of high dose NRT is safe, leads to significant reductions in smoking (-49%), significant but less reductions in total NNAL (-24%) and carbon monoxide (-37%) due to compensatory smoking.
Authors: Dorothy K Hatsukami; Joni Jensen; Lisa H Brauer; Marc Mooney; Susan Schulte; Mehmet Sofuoglu; Paul R Pentel Journal: Pharmacol Biochem Behav Date: 2003-04 Impact factor: 3.533
Authors: Dorothy K Hatsukami; John Slade; Neal L Benowitz; Gary A Giovino; Ellen R Gritz; Scott Leischow; Kenneth E Warner Journal: Nicotine Tob Res Date: 2002 Impact factor: 4.244
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Authors: Arthur L Brody; Alexey G Mukhin; Michael S Mamoun; Trinh Luu; Meaghan Neary; Lidia Liang; Jennifer Shieh; Catherine A Sugar; Jed E Rose; Mark A Mandelkern Journal: JAMA Psychiatry Date: 2014-07-01 Impact factor: 21.596
Authors: Rachel I Vogel; Steven G Carmella; Irina Stepanov; Dorothy K Hatsukami; Stephen S Hecht Journal: Biomarkers Date: 2011-08-03 Impact factor: 2.658
Authors: Danielle Menosi Gualandro; Pai Ching Yu; Bruno Caramelli; André Coelho Marques; Daniela Calderaro; Luciana Savoy Fornari; Claudio Pinho; Alina Coutinho Rodrigues Feitosa; Carisi Anne Polanczyk; Carlos Eduardo Rochitte; Carlos Jardim; Carolina L Z Vieira; Debora Y M Nakamura; Denise Iezzi; Dirk Schreen; Eduardo Leal Adam; Elbio Antonio D'Amico; Emerson Q de Lima; Emmanuel de Almeida Burdmann; Enrique Indalecio Pachón Mateo; Fabiana Goulart Marcondes Braga; Fabio S Machado; Flavio J de Paula; Gabriel Assis Lopes do Carmo; Gilson Soares Feitosa-Filho; Gustavo Faibischew Prado; Heno Ferreira Lopes; João R C Fernandes; José J G de Lima; Luciana Sacilotto; Luciano Ferreira Drager; Luciano Janussi Vacanti; Luis Eduardo Paim Rohde; Luis F L Prada; Luis Henrique Wolff Gowdak; Marcelo Luiz Campos Vieira; Maristela Camargo Monachini; Milena Frota Macatrão-Costa; Milena Ribeiro Paixão; Mucio Tavares de Oliveira; Patricia Cury; Paula R Villaça; Pedro Silvio Farsky; Rinaldo F Siciliano; Roberto Henrique Heinisch; Rogerio Souza; Sandra F M Gualandro; Tarso Augusto Duenhas Accorsi; Wilson Mathias Journal: Arq Bras Cardiol Date: 2017 Jan-Feb Impact factor: 2.000
Authors: André Arpad Faludi; Maria Cristina de Oliveira Izar; José Francisco Kerr Saraiva; Ana Paula Marte Chacra; Henrique Tria Bianco; Abrahão Afiune; Adriana Bertolami; Alexandre C Pereira; Ana Maria Lottenberg; Andrei C Sposito; Antonio Carlos Palandri Chagas; Antonio Casella; Antônio Felipe Simão; Aristóteles Comte de Alencar; Bruno Caramelli; Carlos Costa Magalhães; Carlos Eduardo Negrão; Carlos Eduardo Dos Santos Ferreira; Carlos Scherr; Claudine Maria Alves Feio; Cristiane Kovacs; Daniel Branco de Araújo; Daniel Magnoni; Daniela Calderaro; Danielle Menosi Gualandro; Edgard Pessoa de Mello; Elizabeth Regina Giunco Alexandre; Emília Inoue Sato; Emilio Hideyuki Moriguchi; Fabiana Hanna Rached; Fábio César Dos Santos; Fernando Henpin Yue Cesena; Francisco Antonio Helfenstein Fonseca; Henrique Andrade Rodrigues da Fonseca; Hermes Toros Xavier; Isabela Cardoso Pimentel Mota; Isabela de Carlos Back Giuliano; Jaqueline Scholz Issa; Jayme Diament; João Bosco Pesquero; José Ernesto Dos Santos; José Rocha Faria; José Xavier de Melo; Juliana Tieko Kato; Kerginaldo Paulo Torres; Marcelo Chiara Bertolami; Marcelo Heitor Vieira Assad; Márcio Hiroshi Miname; Marileia Scartezini; Neusa Assumpta Forti; Otávio Rizzi Coelho; Raul Cavalcante Maranhão; Raul Dias Dos Santos; Renato Jorge Alves; Roberta Lara Cassani; Roberto Tadeu Barcellos Betti; Tales de Carvalho; Tânia Leme da Rocha Martinez; Viviane Zorzanelli Rocha Giraldez; Wilson Salgado Journal: Arq Bras Cardiol Date: 2017-07 Impact factor: 2.000
Authors: David Hammond; Jessica L Reid; Pete Driezen; K Michael Cummings; Ron Borland; Geoffrey T Fong; Ann McNeill Journal: Addiction Date: 2008-10 Impact factor: 6.526
Authors: Dorothy K Hatsukami; Anne M Joseph; Mark Lesage; Joni Jensen; Sharon E Murphy; Paul R Pentel; Michael Kotlyar; Eugene Borgida; Chap Le; Stephen S Hecht Journal: Nicotine Tob Res Date: 2007-11 Impact factor: 4.244