Clinical Trials Logo
  1. Home
  2. Tobacco Dependence
  3. NCT01152723

Pharmacokinetics With Two New Oral Nicotine Replacement Products and Nicorette® Gum

Tobacco Dependence Clinical Trial

Official title:
Single-dose Pharmacokinetics With Two New Oral Nicotine Replacement Products and Nicorette® Gum. A Study in Healthy Smokers.

Clinical Trial Summary

Single-dose pharmacokinetics with two new oral nicotine replacement products and Nicorette® gum.

Clinical Trial Description

The study is a single-dose, randomized, cross-over study. The investigational products will be given as single doses at separate visits. The product administrations comprise 30 minutes of chewing. Periods without NRT, lasting for at least 36 hours, will separate treatment visits. Before and after the start of product administration at each treatment visit, blood will be sampled for pharmacokinetic analyses, pre-dose, and during 8 hours after start of product administration. Used gums will be collected and analyzed to determine the amount of remaining nicotine. Subjects will also be monitored to capture any adverse events that may occur. Treatment labels will be concealed from subjects and study personnel. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01152723
Study type Interventional
Source Johnson & Johnson Consumer and Personal Products Worldwide
Contact
Status Completed
Phase N/A
Start date March 2008
Completion date May 2008
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Withdrawn NCT01847300 - cSBI-M for Young Military Personnel N/A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 NCT00722124 - S-Adenosyl-L-Methionine (SAMe) for Smoking Abstinence Phase 2/Phase 3
Completed NCT01113424 - Bioequivalence Between Nicotine Replacement Products and Nicorette® Gum N/A
Completed NCT00747643 - Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement N/A
Completed NCT01238627 - Bioequivalence Between Two Oral Nicotine Sublingual Tablets, 2 mg and 4 mg N/A
Completed NCT01228617 - Single-dose Pharmacokinetics of Oral Nicotine Replacement Products 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