Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction

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StatoCompletato

Sponsor

Mayo Clinic

Collaboratori

National Cancer Institute (NCI)

TEST CLINICO: NCT00392379

BioSeek: nct00392379

Parole chiave

nicotina

Astratto

This study will be a randomized, blinded, placebo-controlled two-group clinical trial. The independent variable is treatment assignment (active 4-mg nicotine lozenge vs. matching placebo lozenge), and the dependent variables are all tobacco and ST abstinence at 3 and 6 months. ST users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo.

Descrizione

Smokeless tobacco (ST) users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo. Both groups will receive a behavioral intervention. The two sites for this clinical trial will be the Mayo Clinic in Rochester, Minnesota (central coordinating site) and the Oregon Research Institute (ORI) in Eugene, OR. A total of 270 ST users will be recruited into this clinical trail. All subjects will be randomized to 4 mg Nicotine Lozenges (taken ad lib) or matching placebo. They will be on study medication for 12 weeks and followed up for 6 months from study enrollment

Date

Ultimo verificato:	03/31/2013
Primo inviato:	10/23/2006
Iscrizione stimata inviata:	10/24/2006
Primo pubblicato:	10/25/2006
Ultimo aggiornamento inviato:	04/15/2013
Ultimo aggiornamento pubblicato:	04/23/2013
Data dei primi risultati presentati:	06/01/2010
Data dei primi risultati QC presentati:	08/08/2010
Data dei primi risultati pubblicati:	08/29/2010
Data di inizio effettiva dello studio:	12/31/2006
Data di completamento primaria stimata:	02/28/2009
Data stimata di completamento dello studio:	02/28/2009

Condizione o malattia

Smokeless Tobacco Use

Intervento / trattamento

Drug: A

Drug: B

Fase

Fase 3

Gruppi di braccia

Braccio	Intervento / trattamento
Experimental: A 4 mg nicotine lozenges for 3 months	Drug: A Nicotine lozenges, 4 mg
Placebo Comparator: B Placebo nicotine lozenges for 3 months	Drug: B Placebo lozenge

Criteri di idoneità

Età idonea per lo studio	18 Years Per 18 Years
Sessi idonei allo studio	All
Accetta volontari sani	sì
Criteri	Inclusion Criteria: - are at least 18 years of age; - report smokeless tobacco (ST) as their primary tobacco of use; - have used ST daily for the past 6 months; - are in general good health (determined by medical history and screening physical examination); - have been provided with, understand, and have signed the informed consent.

Risultato

Misure di esito primarie

1. Prolonged Smokeless Tobacco Abstinence at 3 Months [3 months]

Participants had to have self-reported not having used any tobacco from two weeks past the target quit date to the 3-months post baseline.

Misure di esito secondarie

1. Self-reported Point Prevalence All Tobacco Abstinence at 3 Months [3 months]

Participants had to have self-reported not having used any tobacco for the 7 days prior to the 3 month visit.

2. Prolonged Smokeless Tobacco Abstinence at 6 Months [6 months]

Participants had to have self-reported not having used any tobacco from 2 weeks after the target quit date to 6 months after baseline (22 weeks).