Phase 2 N=130 Health Effects of SLT, Cigarette Smoking, and New Tobacco Products
Nicotine Dependence
Primary: Toxicant Exposure by Products — 835.3; 782.1; 726.8; 0.157 ng/ml — p=0.002
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=81 Nicotine Lozenge or Tobacco-Free Snuff for Smokeless Tobacco Reduction
Tobacco Dependence
Primary: Tobacco Abstinence at 12 Weeks — 8; 5 participants
Phase 3 N=52 Highdose Nicotine Patch Therapy for Smokeless Tobacco Use
Smokeless Tobacco Use
Primary: End of Treatment (Week 8) Point Prevalence Abstinence — 11; 6 participants — p=0.05
N/A N=359 Novel Determinants and Measures of Smokeless Tobacco Use: Study 1
Smokeless Tobacco Use · Tobacco Dependence
Primary: Extent of Toxicity: Mean of Median Values of NNK+NNN in 7 Smokeless Tobacco Brands — 2.4; 2.25; 3.19; 5.51 ug/g
N/A N=104 Evaluation of Oral Tobacco as a Harm Reduction Method for Smokers
Tobacco Use Disorder
Primary: Product Preference — 27; 23; 24; 24 participants
Phase 4 N=432 Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use
Tobacco Use Cessation
Primary: Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco — 125; 85 participants — p=<0.0001
Phase 2 N=237 Efficacy of Varenicline for Smokeless Tobacco Use in India
Tobacco Use Disorder
Primary: 7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment. — 30; 23 participants
Phase 2 N=332 Comparison Across Treatment Conditions to Reduce Smokeless Tobacco Use
Tobacco Use Disorder
Primary: Percent Abstinent From Tobacco at Week 12 (7 Day Point Prevalence) — 31; 17 percentage of randomized — p=0.04
N/A N=1,236 A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco
Smoking · Smoking Cessation
Primary: Quit Attempts and Abstinence — 25.7; 30.8; 19.8; 25.6 percentage of participants
N/A N=76 Varenicline for the Treatment of Smokeless Tobacco
Nicotine Dependence
Primary: 7-day Point Prevalence All Tobacco Abstinence — 21; 16 participants — p=0.126
Phase 3 N=270 Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction
Smokeless Tobacco Use
Primary: Prolonged Smokeless Tobacco Abstinence at 3 Months — 65; 41 Participants — p=<0.05
N/A N=60 Smokeless Tobacco Cessation Intervention for Firefighters
Smokeless Tobacco Cessation
Primary: Number of First Responders Recruited Who Completed a Screening Assessment — 163 Participants
N/A N=1,257 Effects of FDA Authorized Smokeless Tobacco Claims Among US Adults Who Smoke Cigarettes
Tobacco Product Beliefs and Use
Primary: General Relative Harm Perception — 3.04; 2.76; 2.84; 3.19 score on a scale
Phase 2 N=391 Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine
Tobacco Use Disorder
Primary: Product Effect on Complete Substitution for Smoking — 56; 56 participants
Phase 4 N=250 Controlled Study of the Ability of a Smokefree Tobacco Product to Increase the Quit Rate Among Cigarette Smokers
Cigarette Smoking
Primary: Continuous Rate of Smoking Cessation by Self-report and Confirmed by Expired Air Carbon Monoxide Less or Equal Than 8 Ppm — 5; 2 participants
N/A N=31 Impact of Exclusive Use of Low Nicotine Cigarettes on Compensatory Smoking
Smoking
Primary: Breath Sample (Expired Carbon Monoxide) — 18.77; 31.07; 25.38; 30.49 parts per million — p=0.92
N/A N=67 Acceptability of Less Harmful Alternatives to Cigarettes
Bladder Cancer · Cervical Cancer · Esophageal Cancer
Primary: Number of Participants With no Interest in Trial of Harm-reduction Products (HRPs) — 7 participants
N/A N=30 Switching to Potential Reduced Exposure Products in Adult Smokers
Tobacco Use Disorder · Oral Nicotine Pouch Use · Smoking Behaviors
Primary: Number of Cigarettes Smoked Per Day (Log-transformed) — 2.0; 1.8 number of cigarettes smoked
N/A N=150 Methods Project 4: Clinical Trial
Smoker
Primary: Smoke-free Days — 14.5; 0; 0 days
Phase 1 N=100 Oral Mucosal Effects In Adult Smokers Associated With Two Nicotine Lozenge Formulations
Safety Issues
Primary: OMI-20 Total Score Change From Baseline to Day 3 — 0.0; 0.0 score on a scale
Phase 2 N=49 Impact of Nicotine Reduction on Adolescent Cigarette Use, Alternative Tobacco Use, and Harm From Tobacco
Nicotine Dependence, Cigarettes, Uncomplicated
Primary: Average Cigarettes Smoked Per Day — 4.3; 8.0 average cigarettes per day — p=.111
N/A N=136 Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors
Tobacco Addiction · Dual Tobacco Use
Primary: Number of Days Using Alternative Products — 14; 26; 20 Number of days
N/A N=187 Effects Among Smokers Who Use and Do Not Use E-Cigarettes
Toxicant Exposure
Primary: Toxicant Exposure — 40; 97 pg/ml
N/A N=231 A Study to Evaluate Changes in Smokers Using Oral Tobacco-derived Nicotine Products.
Tobacco Use
Primary: Summary of Urine Total NNAL Amount Excreted and Absolute Change From Baseline (ng/24 Hour) by Study Group and Study Day (mITT Population) — 511.889; 581.676; 548.751…
N/A N=103 Addiction and Behavior Related to Menthol Cigarette Substitutes
Smoking (Tobacco) Addiction
Primary: Puffing Topography: Puff Duration — 1.99; 2.06; 2.66; 1.87 seconds
N/A N=33 The Abuse Liability of a Novel Heated Tobacco Product (IQOS) and Its Feasibility as a Menthol Cigarette Substitute
Tobacco Use
Primary: Percent Change in Average Daily Cigarette Use Per Day From Baseline — 36.8; 80.36 % reduction in cigarettes per day
N/A N=154 A Study to Evaluate Changes in Smokers Using An Oral Tobacco-Derived Nicotine Product
Tobacco Use
Primary: Summary Statistics of Percent Change From Baseline for Urinary Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (%) (Per-Protocol Population) — 3.8; 13.8…
N/A N=36 Palatability of Experimental Cigarettes - Study 2
Smoking
Primary: Change in UrineTotal Nicotine Equivalent (TNE) Between Baseline and Week 1 — -16.2; -7.6; 1.3 nmols/ml
N/A N=24 User Acceptability of a Nicotine Lactate Delivery System (P3L)
Smoking
Primary: Change From Baseline Plasma Concentration of Nicotine/Cotinine After Each ad Libitum Use Session. — 1.7621; 2.4113; 1.9446; 5.5571 (ng/mL)
Phase 4 N=90 Tobacco Use Treatment in Cancer Patients
Smoking, Cigarette
Primary: Smoking 7-Day Point Prevalence at 12 Weeks — 2; 2; 3 Participants