N/A N=12 Pharmacokinetics of Nicotine Film in Smokers
Smoking Cessation
Primary: Peak Plasma Nicotine Concentrations Following Ingestion of a Single (Phase 1) or Repeated (Phase 2) Doses of Nicotine Film — 5.78; 20.5; 8.71; 8.80 ng/mL
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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=45 Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product
Tobacco Dependence
Primary: Maximum Plasma Concentration — 3.04; 4.94; 8.63; 6.44 (ng/ml)
Phase 2 N=40 Pharmacokinetic Study of 4 mg Nicotine Lozenge.
Smoking Cessation
Primary: Area Under the Curve From Time 0 to t, AUC (0-t) — 89.14; 87.38; 86.60; 91.97 nanograms (ng)*hours (h)/milliliter (mL)
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
Phase 1 N=200 Oral Tolerability Of Two Nicotine Dosage Forms
Healthy Volunteer Smokers
Primary: Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 1 — 2.3; 12.6 Percentage
Early Phase 1 N=23 Nicotine Delivery Rate and Its Abuse Potential: Impact of Menthol
Nicotine Dependence
Primary: Peak Changes on Items of the Drug Effects Questionnaire (DEQ) - Stimulatory Effects — 7.03; 37.48; 41.91; 28.22 score on a scale
Phase 4 N=47 Nicotine Replacement Therapy in the Intensive Care Unit
Delirium · Psychomotor Agitation · Substance Withdrawal Syndrome
Primary: 30-day Mortality — 9.5; 7.7 percentage of patients
N/A N=40 Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product.
Tobacco Dependence
Primary: Maximum Plasma Concentration — 15.43; 16.49; 30.07; 27.07 (ng/ml)
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
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
Phase 2 N=45 Effects of Random Nicotine Delivery on Smoking Cessation
Smoking Cessation · Cigarette Smoking · Smoking (Tobacco) Addiction
Primary: Change in Number of Cigarettes Smoked Per Day (CPD) — -10.3; -9.0; -7.6 cigarettes per day — p=.55
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
Phase 2 N=7 Nicotine Treatment of Cognitive Decline in Down Syndrome
Down Syndrome · Mild Cognitive Impairment
Primary: Tolerability of Nicotine Intervention — 1; 3 Participants
N/A N=17 Varenicline and Nicotine Interactions in Humans (VA)
Smoking Cessation
Primary: Subjective Responses to Intravenous Nicotine — 23; 38; 51; 14 millimeters — p=<0.05
Phase 2 N=94 The Role of Nicotine Dose and Route of Delivery in Affecting Adoption of E-cigarettes and Reducing Exposure to Toxic Combustion Products
Nicotine Dependence, Cigarettes
Primary: Expired Air Carbon Monoxide (CO) to Assess Recent Smoking — 18.3; 22.9; 21.3; 25.6 Parts per million (ppm) — p=0.01
Phase 4 N=89 Nicotine Administration and Post-operative Opioid Use With Bariatric Surgery
Pain, Postoperative
Primary: Postoperative Opioid Use During the Postanesthesia Care Unit (PACU) Stay, and the First 24 Hours Postoperatively — 5.3; 5.2; 39.6; 32.7 mg — p=0.828
N/A N=38 Clinical Pharmacology of Electronic Cigarettes
Nicotine Dependence
Primary: Standardized Session: Mean CMax — 6.1; 20.2 ng/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
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=26 Nicotine Flux, a Potentially Powerful Tool for Regulating Nicotine Delivery From Electronic Cigarettes
Nicotine Vaping
Primary: Change in Maximum Arterial Blood Nicotine Delivery (Cmax) — 3.75; 2.48; 8.12; 2.96 ng/ml
N/A N=43 Low-Dose Galantamine to Potentiate the Attention-Enhancing Effects of Low-Dose Nicotine
Basic Science Study of the Mechanisms of Attentional Enhancement by Compounds Acting on the Nicotinic Receptor
Primary: Spatial Attentional Resource Allocation Task Predictive Trials Reaction Time — 420; 408; 416; 413 ms
Phase 2 N=16 Effects of Varenicline on Cigarette Self Administration
Nicotine Dependence
Primary: Cigarette Choice — 3.67; 3.17; 2.83; 2.83 number of cigarette choices (0-9)
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=16 Nicotine Pharmacokinetic and Pharmacodynamics Profile, Safety and Tolerability of P3L
Smoking
Primary: Maximum Concentration (Cmax) of Nicotine Following Single Use of Nicorette® Inhalator — 6.095 ng/mL
N/A N=36 Treatment for Nicotine Addiction in Women
Nicotine Dependence
Primary: Withdrawal Symptoms (MNWS Score) — 13.33; 9.40; 11.95; 13.29 score on a scale — p=0.18
Phase 2 N=24 Effects of Semaglutide on Nicotine Intake
Tobacco Use Disorder · Nicotine Addiction
Primary: Change in Nicotine Self-Administration — -0.8; -0.5 Number of cigarettes
Phase 2 N=29 Depressed Mood Improvement Through Nicotine Dosing 2
Depressive Disorder
Primary: MADRS (Montgomery Asberg Depression Rating Scale) Score Change — -15.4 units on a scale — p=< 0.001
N/A N=18 Nicotine Pharmacokinetics and Pharmacodynamics, Safety and Tolerability of P3P
Pharmacokinetics
Primary: Plasma Nicotine Concentration-time Profile — 0.751; 0.336; 0.205; 0.478 ng/mL
Early Phase 1 N=16 Nicotine's Potential Abuse With Menthol
Nicotine Dependence
Primary: Drug Effect Questionnaire - Stimulatory Effects — 39.37; 33.48; 32.35; 33.23 units on a scale — p=0.93