Nicotine Lozenge or Tobacco-Free Snuff for Smokeless Tobacco Reduction

Status Completed

Clinical Trial Summary

Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Extant literature on cigarette smokers suggests that smoking reduction increases smoking abstinence among smokers not interested in quitting. The overarching goal of this line of research is to develop a ST reduction intervention among ST users not interested in quitting tobacco. Our first step is to conduct the proposed pilot study designed to assess the efficacy of the nicotine lozenges or tobacco-free snuff for reducing ST use or facilitating ST abstinence among ST users not interested in quitting.

Clinical Trial Description

In this study, we will enroll 81 subjects who will be randomized to either the nicotine lozenge or tobacco-free snuff to reduce their ST use over 8 weeks with follow-up at 12 weeks. Forty subjects will be recruited at Mayo Clinic in Rochester, MN, and 40 subjects will be recruited at the Oregon Research Institute in Eugene, Oregon. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01018394
Study type	Interventional
Source	Mayo Clinic
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	January 2009
Completion date	July 2012

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01928719` - Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status	N/A
Completed	`NCT01995123` - Behavioral Activation for Smoking Cessation in PTSD	N/A
Not yet recruiting	`NCT03249428` - E-Cigarette Inner City RCT	N/A
Recruiting	`NCT02564289` - Cardiovascular Effects of Chronic Snus Use	N/A
Completed	`NCT01928758` - Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders	N/A
Withdrawn	`NCT01847300` - cSBI-M for Young Military Personnel	N/A
Completed	`NCT01428310` - Study to Evaluate the Safety and Efficacy of Dietary Supplement Anatabloc in Reducing Daily Smokers' Urge to Smoke	Phase 1
Completed	`NCT01570595` - Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV	Phase 1/Phase 2
Recruiting	`NCT00977249` - Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users	Phase 2/Phase 3
Active, not recruiting	`NCT00968513` - Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry	Phase 3
Completed	`NCT00747643` - Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement	N/A
Completed	`NCT01113424` - Bioequivalence Between Nicotine Replacement Products and Nicorette® Gum	N/A
Completed	`NCT00722124` - S-Adenosyl-L-Methionine (SAMe) for Smoking Abstinence	Phase 2/Phase 3
Completed	`NCT01228617` - Single-dose Pharmacokinetics of Oral Nicotine Replacement Products	N/A
Completed	`NCT01238627` - Bioequivalence Between Two Oral Nicotine Sublingual Tablets, 2 mg and 4 mg	N/A
Completed	`NCT00296647` - Smoking Cessation Intervention: Effectiveness in Primary Care	Phase 4
Completed	`NCT00394420` - Emergency Department Telephone Quitline	N/A
Recruiting	`NCT05487807` - Adapting and Evaluating a Tobacco Use Cessation Program for People Living With HIV in Uganda and Zambia	Phase 1
Completed	`NCT03553992` - An Extended Facebook Intervention for Young Sexual and Gender Minority Smokers	N/A
Withdrawn	`NCT05440721` - Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification	N/A