Phase 2 N=326 Low Nicotine Content Cigarettes in Vulnerable Populations: Affective Disorders
Tobacco Use Disorder
Primary: Cigarettes Per Day — 22.54; 14.32; 11.76; 7.63 cigarettes per day
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 4 N=20 Treatment of Nicotine Dependence and Acute Depression
Major Depressive Disorder · Nicotine Dependence
Primary: Hamilton Depression Scale Score — -.5322 percentage of change in depression — p=<.001
Phase 3 N=479 Concurrent Nicotine Patch / Denicotinized Cigarette Therapy for Smoking Cessation II
Cigarette Smoking
Primary: Continuous Abstinence From Smoking at Ten Weeks Post-quit — 31; 21; 17; 26 participants
N/A N=245 Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status
Tobacco Dependence
Primary: Number of Participants Who Dropped Out of Study as a Measure of Adherence — 52; 19 Participants — p=<0.0001
Early Phase 1 N=34 Nicotine Reinforcement and Aversion in Young Adult Light Smokers
Nicotine Addiction
Primary: DEQ - Pleasurable — 2.14; 2.05; 1.98; 2.37 score on a scale
N/A N=326 Low Nicotine Content Cigarettes in Vulnerable Populations: Women of Reproductive Age
Tobacco Use Disorder
Primary: Number of Cigarettes Smoked Per Day — 22.54; 14.32; 11.76; 7.63 cigarettes per day
N/A N=188 Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders
Tobacco Dependence
Primary: Plasma Cotinine Concentration — 82.8; 259.0 ng/mL — p=<0.0001
Phase 3 N=74 Switching to Very Low Nicotine Content Cigarettes vs Reducing Cigarettes Per Day
Tobacco Use Disorder
Primary: Feasibility as Indicated by Self-reported Adherence to Study Cigarettes. — 7.1; 7.3; 10.4; 13.3 Percent non-study cigarettes per day
Phase 2 N=326 Low Nicotine Content Cigarettes in Vulnerable Populations: Opioid Use Disorder
Tobacco Use Disorder
Primary: Number of Cigarettes Smoked Per Day — 22.54; 14.32; 11.76; 7.63 cigarettes per day
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
Phase 4 N=93 Varenicline for Light Smokers
Smoking
Primary: Point Prevalence Smoking Outcome at 12 Weeks (End of Treatment) — 24; 7 participants — p=<0.001
Phase 4 N=42 Nicotine Receptor Density & Response to Nicotine Patch: Pt 2 Extended Treatment
Smoking Cessation · Schizophrenia
Primary: Exhaled Carbon Monoxide (CO) as Parts Per Million (PPM) — 11.5; 12.3; 12.0; 7.8 ppm
N/A N=34 Measuring Neuroadaptations in Response to Very Low Nicotine Content Cigarettes
Tobacco Dependence
Primary: Change in Blood Oxygen Level Dependent (BOLD) Signal Collected by Functional Magnetic Resonance Imaging (fMRI) During Monetary Delay Discounting Task — 0.13; -0.16…
Phase 2 N=75 Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia
Tobacco Use Disorder · Schizophrenia
Primary: Preferred Brand Smoke Intake (CO) — 3.30; 3.16; 9.07; 10.54 ppm
N/A N=31 Cigarette Smoking in Smokers With and Without Schizophrenia
Tobacco Dependence · Schizophrenia
Primary: End-of-session Carbon Monoxide — 62.7; 43.0 parts per million (ppm)
Phase 4 N=96 Combination Nicotine Replacement for Alcoholic Smokers
Smoking · Alcoholism
Primary: 6 Month Smoking Abstinence — 20; 12 percentage of participants abstinent
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=56 Medicinal Nicotine for Preventing Cue Induced Craving
Tobacco Use Disorder
Primary: Craving Symptom Severity Score Assessed Via Questionnaire — 0.52; 0.57; 0.31 units on a scale — p=0.25
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
Phase 2 N=67 Translational Neuropsychopharmacology Research of Nicotine Addiction
Nicotine Dependence, Cigarettes
Primary: Percent Change in Blood Oxygen Level Dependent (BOLD) Signal Response — -0.09; 1.07; 0.08; 1.19 Percentage change
Phase 2 N=775 Project 3, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in People With Current Affective Disorders
Tobacco Use Disorder
Primary: Cigarettes Per Day (CPD) — 25.28; 19.95; 17.74 cigarettes per day — p=<0.0001
N/A N=25 Nicotine Receptor Levels and Smoking Cessation
Smoking Cessation · Nicotine Addiction
Primary: Acetylcholinergic Nicotine Receptor Availability as Determined by 2FA -PET Brain Imaging. — 17.5; 26.8 Distribution Volume Ratio (Vt/fp) — p=0.037
N/A N=112 Nicotine Withdrawal Symptoms and Smoking Relapse
Nicotine Dependence
Primary: BOLD Activation in Right ACC During Parametric Flanker Task tDCS Stimulation — 1.051567464; 0.867749333; 0.8973946; 1.143702607 Percent BOLD change
N/A N=80 Low Nicotine Cigarettes Plus Electronic Cigarettes
Tobacco Dependence
Primary: Urinary NNAL (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol) — 505.6; 459.1; 373.3; 180.5 pg/mg creatinine — p=0.017
N/A N=213 Very Low Nicotine Content Cigarettes and E-Cigarettes in Promoting Smoking Cessation in Daily and Intermittent Cigarette Smokers
Cigarette Smoking-Related Carcinoma · Tobacco-Related Carcinoma
Primary: Usual Brand Cigarettes Per Day — 15.803; 2.1563; 1.8353; 1.4931 Cigarettes per Day
N/A N=369 Cessation in Non-Daily Smokers
Smoking
Primary: Smoking Cessation, Continuous 6-month Abstinence — 13; 10 Participants — p=0.46
N/A N=184 Brain Nicotine Receptor Density in Veteran Smokers
Positron Emission Tomography
Primary: PET Scan, Rating Scales — 7.1; 8.6; 7.9; 8.0 Vt/fp or mL/cm3
N/A N=24 Smokers' Response to Nicotine Dependence Genotyping
Cigarette Smoking · Nicotine Dependence
Primary: Change in Baseline Smoking Abstinence at 6 and 10 Weeks After Genotyping Results — 1; 0; 7; 11 Participants
Phase 2 N=87 Assessment of High Dose Transdermal Nicotine for Fast Metabolizers of Nicotine
Nicotine Dependence
Primary: Biochemically Verified 7-day Point Prevalence Abstinence at the End of 8 Weeks of Treatment — 10; 13 participants
N/A N=150 Methods Project 4: Clinical Trial
Smoker
Primary: Smoke-free Days — 14.5; 0; 0 days