Comparison Across Treatment Conditions to Reduce Smokeless Tobacco Use

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EstatiKonplete

Patwone

University of Minnesota

ESÈ KLINIK: NCT00218296

BioSeek: nct00218296

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Abstrè

Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has health risks associated with its use. While treatment programs that focus on stopping tobacco use may be effective, past research has shown that interventions that specifically focus on reducing tobacco use may be equally effective and may motivate individuals to eventually quit using tobacco. This study will compare the effectiveness of a ST reduction treatment program versus a usual tobacco cessation treatment program (immediate cessation) for reducing tobacco use in ST users.

Deskripsyon

Individuals who use ST are at increased risk for cancer or dying from cardiovascular disease. Other long-term effects include tooth abrasion, gum recession, and loss of bone in the jaw. Many individuals who use ST recognize the health risks associated with ST, but either do not want to quit or feel that it is impossible to quit. For these individuals, tobacco reduction may be an important transitional goal, either prior to quitting or as a treatment endpoint. By participating in a tobacco reduction program, these individuals may be motivated to eventually stop using tobacco altogether. The purpose of this study is to compare a ST reduction treatment program versus a standard tobacco cessation treatment program (immediate cessation) for reducing tobacco use in ST users.

This study will enroll regular users of ST. Participants will be randomly assigned to either a tobacco reduction program or to usual care, a standard tobacco cessation program during the first telephone contact. At the first clinic visit, participants assigned to the tobacco Reduction Group will replace their usual brand of ST with one of two options: an ST brand with less nicotine or nicotine lozenge. Participants will be encouraged to reduce their nicotine intake by at least 50% the first two weeks and encouraged to further reduce their nicotine intake in the following 4 weeks. Participants assigned to the Usual Care Group will be advised to quit and will be asked to set a quit date within two weeks. Telephone counseling, ideas on methods for sustaining cessation, and a self-help manual will also be provided along with a 2 week supply of nicotine patches. Study visits will occur at 2, 4, 8, 12, 26, and 32 (for reduction group) weeks. Outcome assessments will include vital signs, physiological measures related to tobacco use, levels of nicotine reduction, tobacco use status, and measures of motivation and self-efficacy to quit.

Dat

Dènye verifye:	08/31/2017
Premye Soumèt:	09/15/2005
Enskripsyon Estimasyon Soumèt:	09/15/2005
Premye afiche:	09/21/2005
Dènye Mizajou Soumèt:	09/12/2017
Dènye Mizajou afiche:	10/15/2017
Dat premye rezilta yo soumèt:	10/28/2013
Dat premye rezilta QC yo soumèt:	10/28/2013
Dat premye rezilta ki afiche yo:	12/18/2013
Dat aktyèl kòmanse etid la:	10/31/2006
Dat Estimasyon Prensipal Estimasyon an:	12/31/2008
Dat estime fini etid la:	12/31/2008

Kondisyon oswa maladi

Tobacco Use Disorder

Entèvansyon / tretman

Drug: Usual Care Group

Other: Reduction Group

Faz

Faz 2

Gwoup bra

Bra	Entèvansyon / tretman
Active Comparator: Usual Care Group Usual care for cessation with immediate quit date scheduled and two weeks of nicotine patch supplied.	Drug: Usual Care Group Nicotine replacement therapy
Experimental: Reduction Group Reduction in nicotine exposure for 6 weeks prior to quit date using medicinal nicotine lozenge or reduced nicotine smokeless tobacco.	Other: Reduction Group Subject selects preferred method for reduction.

Kritè kalifikasyon yo

Laj ki kalifye pou etid	18 Years Pou 18 Years
Sèks ki kalifye pou etid	All
Aksepte Volontè Healthy	Wi
Kritè	Inclusion Criteria: - No interest in stopping ST use within 90 days of study entry - Daily use of ST in the 6 months prior to study entry Exclusion Criteria: - Current use of tobacco or nicotine products, other than ST - Current unstable medical and mental health conditions - Use of any medication that may affect tobacco use or be affected by a reduction in tobacco use - Pregnant or breastfeeding

Rezilta

Mezi Rezilta Prensipal yo

1. Percent Abstinent From Tobacco at Week 12 (7 Day Point Prevalence) [12 weeks]

No tobacco use 7 days prior to Week 12 verified by biomarkers (urine, cotinine and CO)

2. Percent Prolonged Abstinence From Tobacco at Week 12 [12 weeks]

Continuous tobacco cessation from quit date through Week 12 verified by biomarkers (urine, cotinine and CO)

3. Percent Abstinent From Tobacco at Week 26 (7 Day Point Prevalence) [26 week]

Abstinence from tobacco 7 days prior to Week 26 (Assessed at 26 weeks for Usual Care and 20 weeks for Reduction Group post-quit date)

4. Percent Prolonged Abstinence From Tobacco at Week 26 [26 weeks]

Continuous Abstinence from quit date through Week 26 (Assessed at Week 26 for Usual Care and Week 20 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).

5. Percent Abstinent From Tobacco at Week 32 (7 Day Point Prevalence) [32 Weeks]

Abstinence from tobacco 7 days prior to Week 26 (Assessed at Week 32 for Usual Care and Week 26 for Reduction Group. Reduction Group's quit date is 6 weeks later than Usual Care).

6. Percent Prolonged Abstinence From Tobacco at Week 32 [32 Weeks]

Continuous Abstinence from quit date through Week 32 (Assessed at Week 32 for Usual Care and Week 26 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).

Comparison Across Treatment Conditions to Reduce Smokeless Tobacco Use

Mo kle

nicotine

kansè

tooth wear