Clinical Trials Logo
  1. Home
  2. Tobacco Dependence
  3. NCT01368016

Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Therapy and Nicotine Gum

Tobacco Dependence Clinical Trial

Official title:
Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Product and Nicotine Gum 4 mg. A Study in Healthy Smokers

Clinical Trial Summary

A comparison of two products for oral nicotine replacement with respect to relief of urges to smoke after single doses of nicotine.

Clinical Trial Description

This study will be performed at two sites and two-hundred and fifty (250) healthy male and female subjects will be included. Treatments comprise single doses of an experimental Nicotine Replacement Therapy (NRT) and Nicorette Freshfruit gum 4 mg, which are chewed during 30 minutes. All subjects will be given both treatments in a crossover setting. The length of the time interval separating treatment visits, and during which no NRT must be used, will be at least 36 hours.

The subjects will abstain from smoking from 8 pm the evening before until the end of each visit. The subjects will take the gums according to instructions from the study personnel. After chewing, used gums will be collected for nicotine analysis.

Electronic diaries will be used to collect data. Urges to smoke will be scored on a 100 mm visual analogue scale (VAS) before the start of treatment and during 5 hours thereafter. Subjects will also be monitored to capture any adverse events that may occur. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01368016
Study type Interventional
Source Johnson & Johnson Consumer and Personal Products Worldwide
Contact
Status Completed
Phase N/A
Start date April 2011
Completion date July 2011
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Withdrawn NCT01847300 - cSBI-M for Young Military Personnel N/A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 NCT01570595 - Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV Phase 1/Phase 2
Completed NCT01428310 - Study to Evaluate the Safety and Efficacy of Dietary Supplement Anatabloc in Reducing Daily Smokers' Urge to Smoke Phase 1
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